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
StatusActive
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.

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

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

Study TitleCellular Models of Human Kidney Disease and Regeneration
Principal InvestigatorBenjamin Freedman
Funding AgencyNIH/NIDDK K01 Career Development Award PKD Foundation Research Award ASN Carl W. Gottschalk Research Scholar Grant
StatusActive
Description

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.

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

Study TitleCureGN: Cure Glomerulonephropathy Network
Principal InvestigatorPeter Nelson
Funding AgencyNIDDK
StatusActive
Description

This is a multi-center consortium 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

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

Study TitleGLUTE: Randomized Trial of Glutamine in Chronic Kidney Disease
Principal InvestigatorJonathan Himmelfarb
Funding AgencyNIDDK and New York Medical College
StatusActive
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
StatusActive
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
StatusActive
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 TitleKRI Registry
Principal InvestigatorJonathan Himmelfarb
Funding AgencyKidney Research Institute
StatusActive
Description

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.

Study TitleKRI Repository
Principal InvestigatorJonathan Himmelfarb
Funding AgencyKidney Research Institute
StatusActive
Description

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.

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

Chronic kidney disease may affect the normal functioning of skeletal muscle, leading to fatigue, weakness and changes to the way the body processes nutrients. The main purpose of this study is to understand how CKD affects muscle mitochondria, an essential component of skeletal muscle cells.

Study TitleMENTOR: Membranous Nephropathy Trial Of Rituximab
Principal InvestigatorAshley Jefferson
Funding AgencyMayo Clinic
StatusActive
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.

Study TitleNEPTUNE: Nephrotic Syndrome Study Network
Principal InvestigatorPeter Nelson
Funding AgencyU54 DK083912
StatusActive
Description

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.

Study TitlePDOPPS: Peritoneal Dialysis Outcomes and Practice Patterns Study
Principal InvestigatorRaj Mehrotra
Funding AgencyNIDDK: 5R01DK0991653
StatusActive
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
StatusActive
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 TitleSKS: Seattle Kidney Study
Principal InvestigatorBryan Kestenbaum
Funding AgencyR01HL070938
StatusActive
Description

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.

Study TitleSMART: Smart Phone Application to Improve Renal Transplants
Principal InvestigatorChristopher Blosser
Funding AgencyTapCloud, LLC
StatusActive
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
StatusActive
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
StatusActive
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 TitleUSRDS Special Study Center on Palliative and End-of-Life Care
Principal InvestigatorAnn O'Hare
Funding AgencyNIDDK: 5U01DK102150
StatusActive
Description

The purpose of this research is to evaluate the palliative care needs, quality of communication about end-of-life care, prognostic expectations and readiness to engage in advance care planning among patients with end-stage renal disease

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

The goal of this study is to determine renal clearance parameters of three common medications and compare these measurements with the estimated glomerular filtration rate and proximal tubule solute clearances. The proposed experiemnts will be conducted among participants who have a wide range of kidney function, from normal to severe impairment. This study is a cross-sectional design using a one-sequence cocktail-dosing design regimen of famciclovir, tenofovir, and oseltamivir.

Study TitleWED-HED Study: Wearable Cardioverter Defibrillator in Hemodialysis Patients
Principal InvestigatorNisha Bansal
Funding AgencyZoll, Inc
StatusUpcoming
Description

This study is sponsored by Zoll Services, LLC. The purpose of the study is to evaluate whether the LifeVest device, a wearable cardioverter defibrillator, prevents sudden cardiac deaths in patients with ESRD on hemodialysis.

Study TitleCF: Clearance of 25-hydroxyvitamin D in Cystic Fibrosis
Principal InvestigatorIan de Boer
Funding AgencyNIH
StatusUpcoming
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 TitleACE/ARB study: Genes, Fibrinolysis, and Endothelial Dysfunction
Principal InvestigatorJonathan Himmelfarb
Funding AgencyNHLBI
StatusCompleted
Description

The purpose of this study was to find out if methods of inhibiting angiotensin, a hormone that can cause an increase in blood pressure, differ in their success. In particular, researchers investigated the efficacy of these drugs in terms of cardiovascular events in those undergoing hemodialysis.

Study TitleCoQ10: Coenzyme Q10 Biomarker Trial
Principal InvestigatorJonathan Himmelfarb
Funding AgencyR21 AT004265
StatusCompleted
Description

This trial assessed the effects of the dietary supplement coenzyme Q10 on biomarkers of oxidative stress, systemic inflammation and endothelial function in hemodialysis patients.

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 TitleFish Oil: Omega-3 Fatty Acid Administration in Dialysis Patients
Principal InvestigatorJonathan Himmelfarb
Funding AgencyNCCAM: 5R21AT004265
StatusCompleted
Description

The goal of this study was to examine the role of EPA/DHA supplementation in improving the inflammatory state of uremia and the related muscle protein catabolism in those requiring dialysis.

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 TitlePINTA: A Randomized, Double-blind, Pilot Study of PINTA 745 in Patients with End-Stage Renal Disease who Require Maintenance Hemodialysis and have Protein Energy Wasting
Principal InvestigatorBryan Kestenbaum
Funding AgencyAtara Biopharma
StatusCompleted
Description

Many people on dialysis experience decreased muscle function. This study aimed to assess how the drug PINTA 745 binds to myostatin, a protein involved in controlling muscle growth and inflammation, to see if it is effective in treating protein energy wasting in patients receiving maintenance hemodialysis.

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.

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