Completed Research Studies

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Study TitleASCEND: A Trial of Sertraline vs. CBT for End-Stage Renal Disease Patients with Depression
Principal InvestigatorRaj Mehrotra
Funding AgencyPCORI: CER-1310*07253
StatusCompleted
Description

The study looks at ways to help hemodialysis patients who have depression, either through cognitive behavioral therapy during their dialysis sessions or via drug therapy with sertraline. ClinicalTrials.gov Registration Number: NCT02358343.

Study TitleASPIRED: Assessing Patient-Reported Experience of Care for Home Dialysis
Principal InvestigatorMatthew Rivara
Funding AgencySatellite Healthcare
StatusCompleted
Description

This study aims to develop and validate two instruments to measure patient CES for PD and home HD with input from patients, caregivers, and kidney care professionals. The ultimate goal of development and validation of these instruments is for dissemination and use in clinical practice for quality improvement initiatives, tailoring aspects of care to patients’ values and preferences, and to provide an enhanced voice for home dialysis patients in their ongoing care.

Study TitleASSESS-AKI: Assessment, Serial Evaluation, and Subsequent Sequelae in Acute Kidney Injury
Principal InvestigatorJonathan Himmelfarb
Funding AgencyNIDDK: 5U01DK084012
StatusCompleted
Description

This is a national research study of individuals who were hospitalized and experienced an acute kidney injury (AKI), matched with those who were hospitalized and did not. The goals are to determine whether hospitalized persons who experience an episode of AKI have a (1) greater risk of developing chronic kidney disease or a faster progression of pre-existing CKD or (2) have a higher risk of death, cardiovascular or other adverse events after discharge.

Study TitleBio-PD: Biological Determinants of Peritoneal Dialysis
Principal InvestigatorRaj Mehrotra
Funding AgencyNIDDK: R01DK099165-02
StatusCompleted
Description

This study focuses on the peritoneal dialysis population, and creates a repository of plasma, DNA and spent dialysate samples from pre-existing biorepositories as well as prospectively enrolled subjects. The repository will be used to explore common genetic variants that determine the baseline peritoneal membrane function in patients starting treatment with PD and change in function upon treatment. ClinicalTrials.gov Registration Number: NCT02694068.

Study TitleCANDY: Continuous Glucose Monitoring to Assess Glycemia in Chronic Kidney Disease
Principal InvestigatorIan de Boer
Funding AgencyAmerican Diabetes Association
StatusCompleted
Description

The main purpose of this study is to understand how blood sugar varies in people with diabetes and chronic kidney disease. This information will impact the way blood glucose is managed.

Study TitleCANDY CANE: Continuous Glucose Monitoring to Assess Glycemia in Chronic Kidney Disease – Changing Glucose Management
Principal InvestigatorIan de Boer
Funding AgencyAmerican Diabetes Association
StatusCompleted
Description

The goal of this study is to test, in people with chronic kidney disease, whether two different types of drugs improve their time in normal blood glucose range as well as reduce blood glucose variability. ClinicalTrials.gov Registration Number: NCT02608177.

Study TitleCLEAR: Clearance of 25-hydroxyvitamin D in chronic kidney disease
Principal InvestigatorIan de Boer
Funding AgencyNIDDK: 5R01DK099199
StatusCompleted
Description

Subjects in this study will receive IV administration of vitamin D. We hope to better understand the use of vitamin D in the body and how it is affected by CKD and race. ClinicalTrials.gov Registration Number: NCT02937350.

Study TitleESTEEM: Exercise Study Testing Enhanced Energetics of Muscle Mitochondria in Chronic Kidney Disease
Principal InvestigatorBaback Roshanravan
Funding AgencyNIDDK: 5R01DK101509
StatusCompleted
Description

This trial compares patients who start a 12-week exercise program against those who do not change their regular care. Mitochondria and change in physical functioning will be measured to determine if there was any significant improvement. ClinicalTrials.gov Registration Number: NCT02923063.

Study TitleGLUTE: Randomized Trial of Glutamine in Chronic Kidney Disease
Principal InvestigatorJonathan Himmelfarb
Funding AgencyNIDDK and New York Medical College
StatusCompleted
Description

This study aims to determine positive effects of glutamine, a type of amino acid used to make protein. Subjects receive either glutamine or a placebo to determine if there is any change in the circulatory system and mitochondria (part of the cell responsible for energy production).

Study TitleHealthy Kidney Study
Principal InvestigatorIan de Boer
Funding AgencyNIH
StatusCompleted
Description

This study collects data from people with healthy kidneys to better determine how normal kidney function affects the rate of heart disease, infections and bone disease. The study is taking place at University of Washington, Harborview Medical Center and Northwest Kidney Centers.

Study TitleLUCID: Longitudinal U.S./Canada Incident Dialysis Study
Principal InvestigatorJonathan Himmelfarb
Funding AgencyMassachusetts General Hospital
StatusCompleted
Description

A large prospective observational study of patients beginning dialysis in the U.S. and Canada, LUCID collects information on risk factors and outcomes from an ethnically diverse patient population. The study will also collect and store specimens obtained at baseline and annually for up to two years. There are 170 patients participating in the study.

Study TitleMEND: Muscle Mitochondria Energetics in Chronic Kidney Disease
Principal InvestigatorBryan Kestenbaum
Funding AgencyNIDDK: 5R01DK101509-02
StatusCompleted
Description

People with kidney disease often have muscle weakness and difficulty with mobility. This can affect physical abilities, independence, and quality of life. Mitochondria are the primary energy producing structures in muscle cells. Previous studies suggest that kidney disease may disrupt mitochondrial function; however, these studies have mostly been limited to animal models.

The purpose of this study was to measure mitochondrial properties in people who have chronic kidney disease. We used a specialized procedure to do this in one hand muscle and one leg muscle in 77 participants – 53 kidney disease and 24 controls. We also tested their physical performance using the 6-minute walk test.

Results:

ATPmax – which represents the maximal mitochondrial generation of energy – was lower in the leg muscle of people with CKD but not in the hand muscle. Oxygen uptake was also higher in people with CKD, suggesting a need for more oxygen to achieve the same amount of work. Our specialized measurements of ATPmax tracked strongly with performance on the 6-minute walk test. These results provide further evidence that mitochondrial impairment is an important potential cause of muscle dysfunction in people with chronic kidney disease.

Findings:

This study provides further evidence that kidney disease disrupts the body’s energy producing cells to cause muscle weakness.

Publications:

https://pubmed.ncbi.nlm.nih.gov/32161192/

Study TitleMENTOR: Membranous Nephropathy Trial Of Rituximab
Principal InvestigatorAshley Jefferson
Funding AgencyMayo Clinic
StatusCompleted
Description

This is a multi-center, prospective, randomized, controlled Phase III trial. This study looks into determining whether Rituximab is non-inferior to Cyclosporine in inducing long-term remission of proteinuria in patients with Idiopathic Membranous Nephropathy.

Results:

A total of 130 patients underwent randomization. At 12 months, 39 of 65 patients (60%) in the rituximab group and 34 of 65 (52%) in the cyclosporine group had a complete or partial remission. At 24 months, 39 patients (60%) in the rituximab group and 13 (20%) in the cyclosporine group had a complete or partial remission. Among patients in remission who tested positive for anti-phospholipase A2 receptor (PLA2R) antibodies, the decline in autoantibodies to anti-PLA2R was faster and of greater magnitude and duration in the rituximab group than in the cyclosporine group. Rituximab was non-inferior to cyclosporine in inducing complete or partial remission of proteinuria at 12 months and was superior in maintaining proteinuria remission up to 24 months.

Findings:

Rituximab’s performance was equivalent to Cyclosporine at 12 months and superior at 24 months. Both drugs may be used to treat or prevent the progression of abnormal quantities of protein in the urine but this study showed that Rituximab may be the more effective option in the longer term.

Publications:

https://pubmed.ncbi.nlm.nih.gov/31269364/

https://pubmed.ncbi.nlm.nih.gov/26087670/

Study TitlePDOPPS: Peritoneal Dialysis Outcomes and Practice Patterns Study
Principal InvestigatorRaj Mehrotra
Funding AgencyNIDDK: 5R01DK0991653
StatusCompleted
Description

This observational study is assessing the optimal way to care for peritoneal dialysis patients. The goal is to increase the appropriate use of PD, extend technique survival and improve quality of life for PD patients.

Study TitlePERL: Preventing Early Renal Loss in Diabetes
Principal InvestigatorIan de Boer
Funding AgencyJoslin Diabetes Center
StatusCompleted
Description

This is a multicenter study testing medication therapy for people with type 1 diabetes and early stage kidney disease. The study aims to see if taking allopurinol to decrease uric acid levels may prevent kidney disease in people with type 1 diabetes.

Study TitleSMART: Smart Phone Application to Improve Renal Transplants
Principal InvestigatorChristopher Blosser
Funding AgencyTapCloud, LLC
StatusCompleted
Description

This is a randomized, intent-to-treat, prospective pilot clinical trial study that aims to assess efficacy of a smartphone application in improving quality of life and adherence to anti-rejection medications compared with usual care. This pilot trial is sponsored by TapCloud LLC.

Study TitleSpin-D: Safety and Cardiovascular Efficacy on Spironolactone in Hemodialysis Patients
Principal InvestigatorJonathan Himmelfarb
Funding AgencyNIDDK: Hemodialysis Novel Therapies (HDNT) Consortium
StatusCompleted
Description

The goal of this study is to test the safety and effectiveness of Spironolactone in patients with kidney failure who are on hemodialysis. People with kidney failure have an increased risk of heart failure due to thickening of the heart wall and an increase risk of abnormal heart rhythms. Spironolactone has been approved for treating heart failure; it is not known whether this benefit occurs in patients who also have kidney failure.

Study TitleTarGut: Targeting Gut Microbiome in ESRD
Principal InvestigatorJonathan Himmelfarb
Funding AgencyNIDDK: Hemodialysis Novel Therapies (HDNT) Consortium
StatusCompleted
Description

This study aims to evaluate the safety, tolerability and feasibility of the administration of p-inulin on gut microbiome in ESRD patients who are undergoing hemodialysis.

Study TitleACTION: Anti-Cytokine Therapy for Hemodialysis Inflammation Trial
Principal InvestigatorJonathan Himmelfarb
Funding AgencyNIDDK: Hemodialysis Novel Therapies (HDNT) Consortium
StatusCompleted
Description

The purpose of this study is to evaluate the safety and tolerability of the administration of the drug Anakinra in the suppression of inflammation in hemodialysis patients.

Study TitleCoQ10 Study CKD
Principal InvestigatorBryan Kestenbaum
Funding AgencyNIDDK: 5R01DK101509
StatusCompleted
Description

Volunteers who participate in this study will be assigned to either CoQ10 supplementation for 12 weeks or observation, and we hope to see improvements in physical functioning and mitochondrial function in muscles.

Study TitlePROCLAIM: Proximal Tubule Clearance of Renal Medications Study
Principal InvestigatorBryan Kestenbaum
Funding AgencyNIDDK
StatusCompleted
Description

The kidney tubules are responsible for eliminating hundreds of prescribed medications. Yet, kidney drug dosing is still based on the glomerular filtration rate – a different kidney function. The goal of this study was to compare tubular clearance and the glomerular filtration rate as predictors of kidney drug elimination. We administered two common medications for this purpose: furosemide and penciclovir to 54 people with a wide range of kidney function from chronic kidney disease to normal.

Results:

Kidney tubular clearance strongly predicted the elimination of both test medications. However, the glomerular filtration was only slightly less predictive of kidney medication clearance, suggesting that, among stable outpatients, these two kidney functions are in fact tightly linked. Additional studies are underway to compare these kidney functions in different disease settings, such as acute kidney injury, and for different medications.

Findings:

This study shows that tubular secretory clearance, a kidney function not measured in practice, can be used to accurately predict kidney drug elimination.

Publications:

https://pubmed.ncbi.nlm.nih.gov/33239392/

Study TitleCF: Clearance of 25-hydroxyvitamin D in Cystic Fibrosis
Principal InvestigatorIan de Boer
Funding AgencyNIH
StatusCompleted
Description

This observational study will record how well Vitamin D was processed in the body of patients with Cystic Fybrosis. Subjects in this study will receive IV administration of vitamin D.

Study TitleEDEN-EPO Dosing for Anemia in End-Stage Kidney Disease
Principal InvestigatorJonathan Himmelfarb
Funding AgencyNIH through University of Louisville: R01 DK091584
StatusCompleted
Description

The goal of this study was to improve existing EPO dosing algorithms, with the hope that this will lead to a more personalized and accurate dosing of EPO in people with end-stage renal disease.

Study TitleHemodialysis Fistula Maturation Consortium Study
Principal InvestigatorJonathan Himmelfarb
Funding AgencyNIDDK: 5U01DK08217
StatusCompleted
Description

The overall goal of this study was to better understand the predictors and cause of arteriovenous fistula maturation and failure in hemodialysis patients.

Study TitlePOM: Pomegranate and Hemodialysis Pilot Trial
Principal InvestigatorJonathan Himmelfarb
Funding AgencyPOM Wonderful, LLC
StatusCompleted
Description

This pilot trial assessed the effect of pomegranate juice and extract on biomarkers of oxidative stress, systemic inflammation and monocyte function in hemodialysis patients.

Study TitleSUGAR: Study of Glucose and Insulin in Renal Disease
Principal InvestigatorIan de Boer
Funding AgencyNIDDK: R01DK087726
StatusCompleted
Description

This observational study aimed to better understand how the body’s lack of response to insulin might impact moderate-severe CKD patients

Study TitleVitamin D Metabolism in Cystic Fibrosis
Principal InvestigatorIan de Boer
Funding AgencyNIH
StatusCompleted
Description

We compared banked samples from healthy controls with CF patients in an effort to find problems in vitamin D metabolic pathways. Low Vitamin D levels are common in CF patients and this study hoped to better describe the factors that might affect the way that vitamin D is processed in the body.

Study TitleWAK: Wearable Artificial Kidney
Principal InvestigatorJonathan Himmelfarb
Funding AgencyGift
StatusCompleted
Description

The first U.S. trial of the Wearable Artificial Kidney looked at the safety and effectiveness of the device to deliver dialysis therapy at least equal to existing dialysis machines that deliver thrice weekly in-center hemodialysis treatments.

Study TitleRBK: Rebuilding the Glomerular Filtration Barrier by Regenerating Adult Podocytes
Principal InvestigatorStuart Shankland & Ying Zheng
Funding AgencyNIDDK
StatusCompleted
Description

This project aims to rebuild kidney glomeruli by regenerating podocytes, terminally differentiated cells in the kidney glomerular filtering units that limit the passage of proteins from the blood into the urine, from two candidate resident stem/progenitor cells, cells of renin lineage (CoRL) and parietal epithelial cells (PECs).

Study TitleIdentification of AKI sub-phenotypes based on trajectory of serum creatinine
Principal InvestigatorPavan Bhatraju
Funding AgencyPulmonary and Critical Care Medicine Research Training Grant
StatusCompleted
Description

ICU patients included in the ASSESS-AKI study will be evaluated and identified for AKI sub-phenotypes based on the trajectory of serum creatinine. In addition, the association of AKI sub-phenotypes with long-term outcomes such as incidence and progression of chronic kidney disease and need for renal replacement therapy will be identified. The goal is to develop a more accurate and real-time risk stratifying tool to identify patients at increased risk for poor long-term outcomes after development of AKI in the ICU.

Study TitleBOLD: Blood Pressure Lowering In Dialysis Trial
Principal InvestigatorNisha Bansal
Funding AgencyNIH
StatusCompleted
Description

Description

Under the care of Dr Bansal, 25 Seattle area dialysis patients and 25 San Francisco are dialysis patients took part in this study looking at the feasibility, safety and efficacy of home versus in-center dialysis blood pressure goals.

Blood pressure is one of the most important and treatable risk factors to prevent cardiovascular disease and lower the risk of death. Patients with kidney failure (end-stage-renal disease) treated with hemodialysis have very high risk of cardiovascular disease and death. Patients on hemodialysis are unique in that they can have blood pressures taken at different settings, including at the start of dialysis treatment (in the dialysis unit) or at a regular doctor’s office visit or at home (outside of the dialysis unit). However it remains unknown which of these blood pressures is the best target for treatment in this population.

The purpose of this pilot study was to test if it is possible to adjust dry weight and blood pressure medication to achieve systolic blood pressure <140 mmHg among hemodialysis patients measured in two different settings–at the dialysis unit or at home. We hope this pilot study will lead to a larger scale study to examine whether such different blood pressure management will improve clinical outcomes.

Results:

50 of 70 (71%) patients who were approached agreed to participate. All enrollees completed the study except for 1 who received a kidney transplant. In the home BP treatment group, adherence to obtaining/reporting home BP was 97.4% (and consistent over the 4 months). There was no increased frequency of high (defined as SBP > 200 mm Hg; 0.2% vs 0%) or low (defined as <90 mm Hg; 1.8% vs 1.2%) predialysis BP readings in the home versus predialysis treatment arms, respectively. However, participants in the home BP arm had higher frequency of fatigue (32% vs 16%). This pilot trial demonstrates feasibility and high adherence to home BP measurement and treatment in hemodialysis patients.

Findings:

This pilot trial shows a high home blood pressure measurement rate among participants. This demonstrates that treatment of home blood pressure in hemodialysis patients may be safe and effective but further studies are needed.

Publications:

https://pubmed.ncbi.nlm.nih.gov/32800842/

Study TitleLong-term Outcomes Associated With Implantable Cardioverter Defibrillator in Adults With Chronic Kidney Disease
Principal InvestigatorNisha Bansal Bansal
Funding AgencyNIH
StatusCompleted
Description

Description

Chronic kidney disease (CKD) is common in adults with heart failure and is associated with an increased risk of sudden cardiac death. Randomized trials of participants without CKD have demonstrated that implantable cardioverter defibrillators (ICDs) decrease the risk of arrhythmic death in selected patients with reduced left ventricular ejection fraction (LVEF) heart failure. However, whether ICDs improve clinical outcomes in patients with CKD is not well elucidated.

The objective was to examine the association of primary prevention ICDs with risk of death and hospitalization in a community-based population of potentially ICD-eligible patients who had heart failure with reduced LVEF and CKD.

This noninterventional cohort study included adults with heart failure and an LVEF of 40% or less and measures of serum creatinine levels available from January 1, 2005, through December 31, 2012, who were enrolled in 4 Kaiser Permanente health care delivery systems. Chronic kidney disease was defined as an estimated glomerular filtration rate of less than 60 mL/min/1.73 m2. Patients who received and did not receive an ICD were matched (1:3) on CKD status, age, and high-dimensional propensity score to receive an ICD. Follow-up was completed on December 31, 2013. Data were analyzed from 2015 to 2017.

Results:

A total of 5877 matched eligible adults with CKD (1556 with an ICD and 4321 without an ICD) were identified (4049 men [68.9%] and 1828 women [31.1%]; mean [SD] age, 72.9 [8.2] years). In models adjusted for demographics, comorbidity, and cardiovascular medication use, no difference was found in all-cause mortality between patients with CKD in the ICD vs non-ICD groups (adjusted hazard ratio, 0.96; 95% CI, 0.87-1.06). However, ICD placement was associated with increased risk of subsequent hospitalization due to heart failure (adjusted relative risk, 1.49; 95% CI, 1.33-1.60) and any-cause hospitalization (adjusted relative risk, 1.25; 95% CI, 1.20-1.30) among patients with CKD.

Findings:

This study found that implantable cardioverter defibrillators (ICDs) do not improve clinical outcomes in patients with CKD and heart failure.

Publications:

https://pubmed.ncbi.nlm.nih.gov/27742796/

Study TitleGDF-15, Galectin 3, Soluble ST2, And Risk Of Mortality And Cardiovascular Events In CKD
Principal InvestigatorNisha Bansal
Funding AgencyNIH
StatusCompleted
Description

Description

Inflammation, cardiac remodeling, and fibrosis may explain in part the excess risk for cardiovascular disease (CVD) in patients with chronic kidney disease (CKD). Growth differentiation factor 15 (GDF-15), galectin 3 (Gal-3), and soluble ST2 (sST2) are possible biomarkers of these pathways in patients with CKD.

In this observational cohort study, individuals with CKD enrolled in either of 2 multicenter CKD cohort studies: the Seattle Kidney Study or C-PROBE (Clinical Phenotyping and Resource Biobank Study) will be recruited. The primary outcome was all-cause mortality. Secondary outcomes included hospitalization for physician-adjudicated heart failure and the atherosclerotic CVD events of myocardial infarction and cerebrovascular accident.

Cox proportional hazards models used to test the association of each biomarker with each outcome, adjusting for demographics, CVD risk factors, and kidney function.

 

Results:

Among 883 participants, mean estimated glomerular filtration rate was 49±19mL/min/1.73m2. Higher GDF-15 (adjusted HR [aHR] per 1-SD higher, 1.87; 95% CI, 1.53-2.29), Gal-3 (aHR per 1-SD higher, 1.51; 95% CI, 1.36-1.78), and sST2 (aHR per 1-SD higher, 1.36; 95% CI, 1.17-1.58) concentrations were significantly associated with mortality. Only GDF-15 level was also associated with heart failure events (HR per 1-SD higher, 1.56; 95% CI, 1.12-2.16). There were no detectable associations between GDF-15, Gal-3, or sST2 concentrations and atherosclerotic CVD events.

 

Findings:

This study found that markers of inflammation may be linked with cardiovascular disease and death in patients with CKD.

 

Publications:

 

https://pubmed.ncbi.nlm.nih.gov/29866459/

Study TitleSoluble ST2 And Galectin-3 And Progression Of CKD
Principal InvestigatorNisha Bansal
Funding AgencyNIH
StatusCompleted
Description

Description

Cardiac biomarkers soluble ST2 (sST2) and galectin-3 may reflect cardiac inflammation and fibrosis. It is plausible that these mechanisms may also contribute to the progression of kidney disease. We examined associations of sST2 and galectin-3 with kidney function decline in participants with chronic kidney disease (CKD).

This was a pooled analysis of 2 longitudinal cohorts of participants with CKD: the Clinical Phenotyping and Resource Biobank (C-PROBE) study and the Seattle Kidney Study (SKS). We measured circulating concentrations of sST2 and galectin-3 at baseline. Our primary outcome was progression to estimated glomerular filtration rate (eGFR) <15 ml/min per 1.73 m2 or end-stage renal disease (ESRD). We used competing risk Cox regression models to study the association of sST2 and galectin-3 with CKD progression, adjusting for demographics, kidney function, and comorbidity.

 

Results:

Among the 841 participants in the pooled cohort, baseline eGFR was 51 ± 27 ml/min per 1.73 m2 and median urine albumin-to-creatinine ratio (UACR) was 141 (interquartile range = 15-736) mg/g. Participants with higher sST2 and galectin-3 were more likely to be older, to have heart failure and diabetes, and to have lower eGFR. Adjusting for demographics, kidney function, and comorbidity, every doubling of sST2 was not associated with progression to eGFR <15 ml/min per 1.73 m2 or ESRD (adjusted hazard ratio 1.02, 95% confidence interval = 0.76-1.38). Every doubling of galectin-3 was significantly associated with a 38% (adjusted hazard ratio = 1.35, 95% confidence interval = 1.01-1.80) increased risk of progression to eGFR <15 ml/min per 1.73 m2 or ESRD.

Findings:

This study demonstrates that higher levels of markers of inflammation may be linked with progression of CKD.

 

Publications:

https://pubmed.ncbi.nlm.nih.gov/30596173/

Study TitleBlood Pressure And Risk Of All-Cause Mortality in Advanced Chronic Kidney Disease and Hemodialysis: The Chronic Renal Insufficiency Cohort Study
Principal InvestigatorNisha Bansal
Funding AgencyNIH
StatusCompleted
Description

Description

Studies of hemodialysis patients have shown a U-shaped association between systolic blood pressure (SBP) and mortality. These studies have largely relied on dialysis-unit SBP measures and have not evaluated whether this U-shape also exists in advanced chronic kidney disease, before starting hemodialysis. We determined the association between SBP and mortality at advanced chronic kidney disease and again after initiation of hemodialysis. This was a prospective study of Chronic Renal Insufficiency Cohort participants with advanced chronic kidney disease followed through initiation of hemodialysis.

Results:

We studied the association between SBP and mortality when participants (1) had an estimated glomerular filtration rate <30 mL/min/1.73 m2 (n=1705), (2) initiated hemodialysis and had dialysis-unit SBP measures (n=403), and (3) initiated hemodialysis and had out-of-dialysis-unit SBP measured at a Chronic Renal Insufficiency Cohort study visit (n=326). Cox models were adjusted for demographics, cardiovascular risk factors, and dialysis parameters. A quadratic term for SBP was included to test for a U-shaped association. At advanced chronic kidney disease, there was no association between SBP and mortality (hazard ratio, 1.02 [95% confidence interval, 0.98-1.07] per every 10 mm Hg increase). Among participants who started hemodialysis, a U-shaped association between dialysis-unit SBP and mortality was observed. In contrast, there was a linear association between out-of-dialysis-unit SBP and mortality (hazard ratio, 1.26 [95% confidence interval, 1.14-1.40] per every 10 mm Hg increase). In conclusion, more efforts should be made to obtain out-of-dialysis-unit SBP, which may merit more consideration as a target for clinical management and in interventional trials.

Findings:

This study demonstrates that out-of-dialysis-unit blood pressure measurements may be more accurate and, therefore, more useful for clinical and research purposes.

Publications:

https://pubmed.ncbi.nlm.nih.gov/25287404/

Study TitleBlood Pressure And Risk Of Cardiovascular Events In Patients On Chronic Hemodialysis: The CRIC Study (Chronic Renal Insufficiency Cohort)
Principal InvestigatorNisha Bansal
Funding AgencyNIH
StatusCompleted
Description

Description

We recently reported a linear association between higher systolic blood pressure (SBP) and risk of mortality in hemodialysis patients when SBP is measured outside of the dialysis unit (out-of-dialysis-unit-SBP), despite there being a U-shaped association between SBP measured at the dialysis unit (dialysis-unit-SBP) with risk of mortality. Here, we explored the relationship between SBP with cardiovascular events, which has important treatment implications but has not been well elucidated. Among 383 hemodialysis participants enrolled in the prospective CRIC study (Chronic Renal Insufficiency Cohort), multivariable splines and Cox models were used to study the association between SBP and adjudicated cardiovascular events (heart failure, myocardial infarction, ischemic stroke, and peripheral artery disease), controlling for differences in demographics, cardiovascular disease risk factors, and dialysis parameters.

 

Results:

Dialysis-unit-SBP and out-of-dialysis-unit-SBP were modestly correlated (r=0.34; P<0.001). We noted a U-shaped association of dialysis-unit-SBP and risk of cardiovascular events, with the nadir risk between 140 and 170 mm Hg. In contrast, there was a linear stepwise association between out-of-dialysis-unit-SBP with risk of cardiovascular events. Participants with out-of-dialysis-unit-SBP ≥128 mm Hg (top 2 quartiles) had >2-fold increased risk of cardiovascular events compared with those with out-of-dialysis-unit-SBP ≤112 mm Hg (3rd SBP quartile: adjusted hazard ratio, 2.08 [95% confidence interval, 1.12-3.87] and fourth SBP quartile: adjusted hazard ratio, 2.76 [95% confidence interval, 1.42-5.33]). In conclusion, among hemodialysis patients, although there is a U-shaped (paradoxical) association of dialysis-unit-SBP and risk of cardiovascular disease, there is a linear association of out-of-dialysis-unit-SBP with risk of cardiovascular disease. Out-of-dialysis-unit blood pressure provides key information and may be an important therapeutic target.

Findings:

These results support the argument that utilizing systolic blood pressure (SBP) measurements outside of the dialysis unit may be more appropriate in clinical practice and research.

Publications:

https://pubmed.ncbi.nlm.nih.gov/28674037/

Study TitleSMART: Smart Phone Application to Improve Renal Transplants
Principal InvestigatorChristopher Blosser
Funding AgencyTapCloud, LLC
StatusCompleted
Description

Description

In this prospective cross-sectional pilot study of prevalent 18-34 year-old KTRs cared for at the University of Washington Transplant Program, we assessed the feasibility and potential efficacy in improving KTRs’ quality of life (QoL) over 3 months with TapCloud technology that integrates patient-reported information, medication reminders and a patient-provider communication link. This pilot study is sponsored by TapCloud LLC.

Results: 

Use of TapCloud was consistent across subgroups, with signs that early post-transplant recipients (<1 yr), younger KTRs (<29 yrs) and KTRs with high school or equivalent education may have used the app more than older, more educated KTRs and those further from transplant. Increased use and earlier post-transplant use were associated with improved physical measures of QoL via KTQ-25 survey (higher scores are better) from start to end of study.

Findings:

This pilot study provides valuable feasibility and patient-oriented data demonstrating mobile health technology may help improve kidney transplant recipients quality of life and clinical outcomes and requires further study.

Study TitleASPIRED: Assessing Patient-Reported Experience of Care for Home Dialysis
Principal InvestigatorMatthew Rivara
Funding AgencySatellite Healthcare
StatusCompleted
Description

Description: 

This study aimed to develop and validate one instrument to measure patient-care experience satisfaction for peritoneal dialysis (PD) and home hemodialysis (HD) with input from patients, caregivers, and kidney care professionals.  The ultimate goal of development and validation of this instrument is for dissemination and use in clinical practice for quality improvement initiatives, tailoring aspects of care to patients’ values and preferences, and to provide an enhanced voice for home dialysis patients in their ongoing care.  Instrument development was accomplished using a mixed-methods multiple stakeholder approach that employed focus groups, interviews, and a prioritization survey among patients, nurses, care partners, and nephrologists.

Results/Findings:

Development of a final instrument for measurement of patient experience of care in home dialysis was completed in March 2020, and demonstrated that the home dialysis domains of highest importance to patients for inclusion were patient education and communication, care coordination, and personalization of care. In collaboration with Satellite Healthcare, the instrument, entitled the Home Dialysis Care Experience (Home-DCE) instrument, was administered to nearly 500 patients undergoing PD or home HD at Satellite dialysis facilities in the summer and fall of 2020.  Results from the survey administration will be used to determine the psychometric (measurement) properties of the Home-DCE instrument.

Study TitleDialysis Decision-Making among Adults with Advanced Kidney Disease
Principal InvestigatorSusan Wong
Funding AgencyNIDDK
StatusCompleted
Description

Dialysis Decision-Making among Adults with Advanced Kidney Disease

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