Clinical Trials

Nephrology Clinical Trials Seeking Enrollment at Duke

We are currently conducting trials in each of these areas

Chronic Kidney Disease

Hypertension

Glomerulonephritis

Dialysis

Kidney Transplantation

Contact John P. Middleton, MD if you are interested in more information

Date: September 20, 2015

Trials in Chronic Kidney Disease

ABC Study

PI: Julia Scialla

ClinicalTrials.gov Identifier: NCT02427594

Currently enrolling adults with CKD

Acid-Base Compensation in CKD (ABC study): Measurement and Physiologic Impact.  The study will evaluate the role of reducing the dietary acid load with sodium bicarbonate on net acid excretion, ambulatory blood pressure, and metabolomic profiles in a 3-4 week study.

CREDENCE

Site PI: John Middleton

ClinicalTrials.gov Identifier: NCT02065791

Currently enrolling patients with diabetic nephropathy

This is a randomized, double-blind, event-driven, placebo-controlled, multicenter study of the effects of the SGLT-2 inhibitor canagliflozin on renal and cardiovascular outcomes in subjects with T2 diabetes mellitus and diabetic nephropathy.

Trials in Hypertension

SPYRAL Trials

Site Co-Investigator: Crystal Tyson

ClinicalTrials.gov Identifiers: NCT02439775; NCT02439749

Currently enrolling adults with uncontrolled hypertension

SPYRAL includes two multi-center, prospective randomized, sham-controlled trials designedto evaluate the safety and efficacy of renal denervation to lower BP in adults with uncontrolled hypertension.

TRIUMPH Study

Site Co-Investigator: Crystal Tyson

ClinicalTrials.gov Identifier:NCT02342808

Currently enrolling adults with uncontrolled hypertension

TRIUMPH is a prospective, randomized trial to test the effectiveness of a 16-week lifestyle intervention involving diet and weight loss counseling and thrice-weekly supervised exercise, to lower BP in adults with resistant hypertension.

Trials in Glomerulonephritis

Pathogenesis of Goodpasture Syndrome

Site PI: Mary Foster

Currently enrolling patients with anti-GBM nephritis and Goodpasture Syndrome

This study involves blood donation (and plasmapheresis fluid from patients if available) for use for in vitro studies on the glomerular injury in autoimmune glomerular diseases. 

Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Adults and Children 6 Years and Older With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

Sponsor: BMS

Clinicaltrials.gov ID:  NCT02592798

Site PI: R. Gbadegesin

This is a A Phase II randomized, placebo-controlled, double-blind, parallel arms with switchover, pilot study to evaluate the efficacy and safety of intravenous Abatacept in treatment resistant nephrotic syndrome (Focal Segmental Glomerulosclerosis/ Minimal change).  The purpose of this study is evaluate if abatacept is effective and safe in decreasing the level of protein loss in the urine in patients with excessive loss of protein in the urine (nephrotic syndrome) due to either focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD). Candidates must have a prior kidney biopsy with either diagnosis. Eligible patients must have failed or be intolerant of prior therapy for their kidney disease. The failed or intolerant therapy must include corticosteroids and at least one other drug. Eligible patients can be adults and children over the age of 6. Abatacept will be administered by venous infusion every 4 weeks in this trial.

Trials in Dialysis

Improving Quality of Life Measurement in Older Dialysis Patients

PI: Rasheeda Hall

Enrolling patients with ESRD on dialysis

This is a qualitative research study in which prevalent dialysis patients > 70 years of age will be recruited to participate in semi-structured interviews about quality of life. The interviews will include functional assessment, administration of the KDQOL-36, and open-ended questions about life on dialysis. 

Computational Approach to Personalized Anemia Management

Site PI: John Middleton

ClinicalTrials.gov Identifier: NCT01719146

Enrolling patients with ESRD on hemodialysis

This is an observational study that collects information from hemodialysis patients on their outcomes and interventions to manage CKD-associated anemia.  The goal is to develop computational models to optimize the therapy of anemia in this vulnerable population.

WED-HED: Wearable Cardioverter Defibrillator in Hemodialysis Patients

Site PI: Patrick Pun

ClinicalTrials.gov Identifier: NCT02481206

Enrolling patients with ESRD on hemodialysis

A multi-center, prospective, randomized controlled clinical trial with 1:1 assignment of treatment and control. This study will evaluate the impact of wearable cardioverter defibrillator use on sudden cardiac death in incident hemodialysis patients.

RENal hemodialysis patients ALlocated apixaban versus warfarin in Atrial Fibrillation (RENAL-AF) Randomized Clinical Trial

Sponsor: BMS

Site PI: Middleton

This is an open label prospective trial being performed in ESRD patients on hemodialysis who have atrial fibrillation comparing apixaban 5mg BID (or apixaban 2.5mg BID in patients ≥ 80 years of age and/or ≤ 60 kg) vs. adjusted-dose warfarin. Duration of treatment will be a maximum of 15 months and the target is a mean follow-up of approximately 12 months.  The primary objective will be to compare the safety of apixaban versus warfarin with respect to major bleeding or clinically relevant non-major bleeding events in patients with ESRD on hemodialysis and non-valvular atrial fibrillation.

Trials in Kidney Transplantation

Transplant Social Worker Support for Live Kidney Donation in African American Patients

Site PI: Matthew Ellis

ClinicalTrials.gov Identifier: NCT02369354

Enrolling African American patients with ESRD

This study examines the effectiveness of a culturally sensitive and health literacy-sensitive transplant social worker intervention to improve live kidney donation and transplantation among African Americans with ESRD.

A Phase 2A randomized open-label active control multicenter trial to assess the efficiency and safety of ASKP1240 in de novo kidney transplant recipients.

Site PI: Matthew Ellis

ClinicalTrials.gov Identifier: NCT01780844

Enrolling kidney transplant recipients

This study aims to understand the effects of ASKP1240 in kidney transplant patients at risk for delayed graft function.

Evaluation of the benefits and risks of maintenance renal transplant recipients following conversion to Nulojix (belatacept)-based immunosuppression

Site PI: Matthew Ellis

ClinicalTrials.gov Identifier: NCT01820572

Enrolling kidney transplant recipients

This study evaluates the safety of switching first-time kidney transplant patients from immunosuppression with a calcineurin inhibitor to belatacept.

Solid organ transplantation and the use of raltegravir in HIV-infected patients: An observational study of pharmacokinetics, safety, and efficacy.

Site PI: Matthew Ellis

ClinicalTrials.gov Identifier: NCT01793467

Enrolling kidney transplant patients with HIV infection.