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.
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.
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.
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.
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.
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.
This is a registry for patients with kidney disease or a disease syndrome with a kidney component. Participants send in urine or hair samples which are used to generate stem cells. The stem cells are used to generate new kidney cells for the study of kidney disease and regeneration in the laboratory.
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.
This is a multi-center consortium sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) that aims to work collaboratively to address major challenges to understanding the underlying biology of Minimal Change Disease, FSGS, MN and IgAN. The goal is to recruit and maintain a large cohort of patients (2,400) with glomerular disease and follow them prospectively with standardized clinical data and biospecimen collection. In April 2020 CureGN 2.0 launched, extending the study for an additional 5 years.
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.
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).
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.
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.
Patients interested in taking part in ongoing and future research studies are invited to join the KRI registry, a database that allows investigators to identify potential subjects for research. The registry increases patient participation in research at the KRI.
The purpose of the repository is to use banked data and specimens for the study of kidney disease in the future. Samples may come from hemodialysis, peritoneal dialysis and chronic kidney disease patients, as well as people with normal kidney function. Some banked samples from PD patients will be added to the International Bio-PD study, a study that looks at genetic markers that impact how well peritoneal dialysis works at baseline. A second aim is to look at pathways that contribute to the decline of the PD membrane over time. More than 4,800 patients from the U.S., Europe and Australia will participate.
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.
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.
This study provides further evidence that kidney disease disrupts the body’s energy producing cells to cause muscle weakness.
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.
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.
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.
This study is sponsored by the Office of Rare Diseases, NIH, NIDDK, DHHS, NephCure Kidney International, and University of Michigan. It is a longitudinal observational study that, among others, aims to establish a collaborative, integrated and cost-effective investigational infrastructure to conduct clinical and translational research in FSGS, MCD, MN and childhood onset NS.
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.
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.
We launched the Seattle Kidney Study in 2004 to better understand risk factors and the progression of CKD to ESRD. Almost 700 people have enrolled in this study and we are recording their kidney disease symptoms, medications, physical activity and functioning, and collecting biological specimens.
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.
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.
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.
Under a contract with the USRDS Coordinating Center at Hennepin County Medical Center in Minneapolis we analyze updated information on a survey we conducted among patients on diaysis at dialysis facilities in the greater Seattle and Nashville areas and their family members from 2015-2018 to produce an annual “patient experience” chapter for the USRDS Report. The survey includes questions pertaining to multiple different domains of end-of-life care including engagement in advance care planning, treatment preferences, values around life prolongation, preferred role in making treatment decisions and expectations about prognosis. The most recent chapter can be found here: https://adr.usrds.org/2020/end-stage-renal-disease/12-patient-experience-end-of-life-care-for-patients-with-esrd
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.
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.
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.
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.
This study shows that tubular secretory clearance, a kidney function not measured in practice, can be used to accurately predict kidney drug elimination.
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.
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.
The overall goal of this study was to better understand the predictors and cause of arteriovenous fistula maturation and failure in hemodialysis patients.
This pilot trial assessed the effect of pomegranate juice and extract on biomarkers of oxidative stress, systemic inflammation and monocyte function in hemodialysis patients.
This observational study aimed to better understand how the body’s lack of response to insulin might impact moderate-severe CKD patients
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.
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.
This study evaluates views concerning providing genetic testing information about the Apolipoprotein (APOL1) gene mutation to patients and family members who may be at risk for kidney disease. The goal of the study is to address a bioethics concern, specifically to gain community input on the question of genetic testing for kidney disease risk in African American communities.
This study uses “real world” data to study the efficacy and safety of atrial fibrillation therapies in patients with chronic kidney disease. This study is evaluating ~250,000 patients with incident atrial fibrillation, with and without CKD, to evavaluate adverse effects of commonly used atrial fibrillation therapies and procedures. Further, the study will evaluate whether successful use of atrial fibrillation therapies and procedures reduces rates of stroke, progression of kidney disease, heart failure and death.
This study aims to assess a scenario-planning communication tool designed to help physicians and patients with advanced kidney disease arrive at treatment decisions aligned with patient goals, values, and preferences.
Diabetes affects the small blood vessels of the eye and kidney. This is a cross-sectional, observational study exploring associations between kidney biopsy findings and eye imaging findings in adults with diabetes. We will be using optical coherence tomography, a high-resolution imaging technique, to obtain detailed mapping of retinal blood vessels.
This study aims to evaluatie real world outcomes in participants who receive in-home dialysis on the Tablo Hemodialysis System. It is a prospective, multicenter trial for treatment of participants with end stage renal disease in the home setting. Approxiamtely 250 participants will be enrolled at up to 30 sites. Participants will be followed for 12 months.
This is a pilot study to prospectively assess peritonitis events in peritoneal dialysis (PD) patients over a 1-year study period. This study is also looking at capturing peritonitis events that have occurred prior to an individual commencing PD at home while distinguishing between variable peritonitis events.
This is a multi-center clinical trial testing the impact of a video-based decision aid for treatment of advanced kidney disease in supporting patients with making treatment decisions that uphold their healthcare goals.
This project is a collaboration between Nortis Inc. and the University of Washington School of Pharmacy. The goal of this project is to develop commercially viable kidney proximal tubule microphysiologic systems (KPT-MPS) using rat and canine proximal tubule epithelial cells (PTECs) that can be used in pre-clinical drug development to identify potential nephrotoxicity.
The goal of this project is to model microvascular interactions with immune cells and humoral factors as initiating tubulo-interstitial disease in lupus nephritis and use a novel renal vascular tubular unit to create an integrated MPS model of lupus nephritis.
Using our ‘human kidney-on-a-chip’ microphysiological systems (MPS), this project aims to better understand the mechanisms of kidney involvement in COVID-19 infection to foster development of effective therapies beyond supportive care. We aim to 1) Characterize SARS-CoV-2 (COVID-19) receptor expression, binding, engagement and modulation in kidney proximal tubular epithelial cells, podocytes, and microvascular endothelial cells within human kidney and vascular MPS, and 2) Assess SARS-CoV-2 (COVID-19) candidate therapeutics including recombinant ACE 2, DPP-4 inhibitors, and angiopoietin 1 hyper-signaling constructs for ability to block kidney specific cellular uptake of SARS-CoV-2 (COVID-19) and/or alter downstream signaling and injury phenotypes within human kidney and vascular MPS.
We hypothesize that kidney-on-a-chip microphysiological systems (MPS) will manifest patient-specific phenotypic responses in vitro commensurate with clinical trial outcomes in vivo, establishing a robust molecular and cellular basis for kidney precision medicine approaches.
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).
This is a repository of fresh urine from healthy donors, that can be accessed by any researcher needing such a resource for their study. Up to 20L of urine will be available at any time.
This is a parallel group randomized controlled trial looking at insomnia in the dialysis population. 126 hemodialysis patients will be enrolled in community-based dialysis facilities in Seattle and New Mexico and randomized to 6 week treatment to telehealth cognitive based therapy, trazodone, or medication placebo. Response to treatment will be assessed after 6 weeks of treatment, and persistence of treatment effect will be ascertained at 25 weeks.
This complementary study to ROKIT will determine whether COVID-19 infection impairs the functioning of the kidney tubules in critical illness.
This study, conducted in partnership with Vanderbilt University, seeks to identify new methods of measuring kidney function in critically ill adults. The study will evaluate the secretory function of the kidney proximal tubules using novel methods and determine associations with prognosis and kidney drug dosing.
The goal of this project is to change the treatment paradigm for diseases affecting the podocytes, cells that physically filter the blood to form the urine, by combining therapeutics development with cell-specific delivery to enhance the natural ability of the body to repair and regenerate these highly specialized cells.
The goal of this work is to develop and pilot test a new communication tool to facilitate shared decision-making for treatment of advanced kidney disease and end-of-life care.
This is a multicenter follow-up study for PERL participants. PERL tested medication therapy for people with type 1 diabetes and early stage kidney disease. The PERL study aimed to see if taking allopurinol to decrease uric acid levels may prevent kidney disease in people with type 1 diabetes.
This study is a pilot, double-blind, placebo-controlled, multicenter, interventional clinical trial with oral nicotinamide riboside (NR) 500 mg (versus placebo) twice daily for a total of 10 days in hospitalized participants with COVID-19. Biospecimens will be collected in participants.
The KPMP consortia is focused on finding new ways to treat AKI and CKD. Renal tissue will be obtained from participating volunteers, and will be analyzed in an effort to redefine kidney disease in molecular terms and identify novel targeted therapies. The consortia will develop state-of-the-art methods to obtain and analyze these biopsies, linking information on cellular programs with kidney structure. The Kidney Research Institute serves as the central hub for this project.
KIND-HF is a prospective study of 400 patients admitted with acute decompensated heart failure at a UW hospital.. The study will compare traditional and novel measures of kidney function and the response to treatment for acute decompensated heart failure while in the hospital and post discharge.
The goal of this research is to develop a model system that predicts drug handling (especially drug excretion and kidney toxicity) in the human kidney. Using this model, researchers will emulate healthy and disease related conditions.
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.
The goal of this study is to evaluate new markers of kidney function that focus on the kidney tubules in people with cirrhosis of the liver.
Patients undergoing long-term dialysis with chronic pain needing opioids will be enrolled in a clinical trial to test multiple strategies to see if they help patients get off prescription opioids. Some patients will receive pain coping skill therapy (PCST) or usual care. After an initial period of treatment, people who are using significant doses of opioids will be randomly assigned to be offered treatment with buprenorphine or usual care, to determine if it allows for a decrease in use of full-agnoist opioids.
This study looks at patients with chronic kidney disease. The goal of this study is to examine a panel of clinically available and novel cardiac biomarkers measured in the blood of patients with kidney disease to identify novel mechanisms that contribute to the risk of heart disease in patients with chronic kidney disease.
This study looks at patients presenting to the Emergency Department with sepsis or septic shock. It examines associations between fluid management and time to antimicrobial administration with renal outcomes.
The goal of this work is to develop and pilot test a dedicated decision aid for conservative care to improve informed and shared decision-making for the treatment of advanced chronic kidney disease
This is a randomized clinical trial testing two agents that target mitochondria (the energy producing units of muscle): coenzyme Q10 and nicotinamide riboside for improving exercise efficiency in people with chronic kidney disease.
This study is being done to find out whether treatment of major depression with the medication, Bupropion, Behavioral Activation Teletherapy (BAT), both, Clinical Management (CM) and/or placebo will improve depression, quality of life and overall functioning in CKD patients. The secondary purpose is to find out whether CKD patients will be able to tolerate these treatments.
This is a prospective observational cohort study enrolling patients admitted to the intensive care unit and at high risk for organ dysfunction, such as acute kidney injury or respiratory failure. Clinical data is collected till 90 days after hospitalization and biological samples are collected at two time points during hosptializaton.
This is a prospective observational cohort study that is enrolling patients with COVID-19 and patients with suspicion of COVID-19 but who ultimately are PCR negative. Biological samples are collected at three main time-points over hospitalization.
This is a multi-center, prospective, cohort study of CloudCath system for the early detection of peritonitis in patients undergoing peritoneal dialysis. The CloudCath system analyzes effluent dialysis solution for changes associated with peritonitis, and then uploads the data to a cloud portal for analysis. Participants are asked to use the CloudCath system for 12 continuous months.
This project will send a kidney model created through our Kidney on a Chip study to the International Space Station in order to understand how microgravity and other factors affect kidney function, and to use these discoveries to design better treatments for proteinuria, osteoporosis, and kidney stones on earth.
This prospective cohort study looks at incidence and severity of hypoglycemia in dialysis patients through use of a continuous glucose monitoring (CGM) device. The study aims to enroll up to 600 participants, along with non-dialysis control subjects. Patients undergoing hemodialysis or peritoneal dialysis for kidney failure are eligible for enrollment.