Clinical Trials

Nephrology Clinical Trials and Other Human Subject Research 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: June 29, 2018

Trials in Chronic Kidney Disease

Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants with Diabetic Nephropathy (CREDENCE)

Sponsor: Janssen Research & Development, LLC

ClinicalTrials.gov ID: NCT02065791

Site PI: John Middleton

Currently not recruiting

The goal of this study is to assess whether canagliflozin (SGLT-2 inhibitor) has a renal and vascular protective effect in reducing the progression of renal impairment relative to placebo in participants with type 2 diabetes mellitus, Stage 2 or 3 chronic kidney disease and macroalbuminuria, who are receiving standard of care including a maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker.

 

The BASE Study: Bicarbonate Administration to Stabilize Estimated Glomerular Filtration Rate (eGFR)

Sponsor: NIDDK

ClinicalTrials.gov ID: NCT02521181

Site PI: John Middleton

Currently not recruiting

Sodium bicarbonate, also known as baking soda, may help prevent kidney failure in people with chronic kidney disease. The purpose of the BASE Study is to help inform the decision regarding sodium bicarbonate dose for a Phase 3 trial by examining the safety, compliance, and pharmacodynamics of two rational doses of sodium bicarbonate in patients who have chronic kidney disease.

MURDOCK Kidney Health Study

PI: Julia Scialla

The study aim is to understand factors that prevent the development of kidney disease in people at risk. The study will focus on the relationships between diet, bacteria living within the gastrointestinal tract (known as the gut microbiota), differences in metabolism, and the risk of kidney disease.

Trials in Hypertension

A Multicenter Study to Evaluate the ROX Coupler in Subjects with Hypertension (CONTROL HTN-2)

Sponsor: ROX Medical, Inc.

ClinicalTrials.gov ID: NCT02895386

Site Co-Investigator: Crystal Tyson

Currently enrolling patients with uncontrolled hypertension

The ROX Coupler is a device placed by minimally invasive procedure between the artery and vein in the upper thigh (between the iliac artery and vein) to allow a fixed amount of blood to flow between them, known as an arteriovenous anastomosis. This study is to evaluate the safety and effectiveness of the ROX Coupler in patients with uncontrolled hypertension.

 

Global Clinical Study of Renal Denervation with the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients with Uncontrolled Hypertension in the Absence of Antihypertensive Medications (SPYRAL HTN-OFF MED)

Sponsor: Medtronic Vascular

ClinicalTrials.gov ID: NCT02439749

Site Co-Investigator: Crystal Tyson

Currently enrolling patients with uncontrolled hypertension

SPYRAL Trial is designed to evaluate the safety and efficacy of renal denervation to lower blood pressure in adults with uncontrolled hypertension. The purpose of SPYRAL HTN-OFF MED study is to obtain an assessment of the efficacy and safety of renal denervation in the absence of antihypertensive medications.

 

Treating Resistant Hypertension Using Lifestyle Modification to Promote Health (TRIUMPH)

Sponsor: Duke University

Site Co-Investigator: Crystal Tyson

ClinicalTrials.gov ID: NCT02342808

ClinicalTrials.gov ID: NCT03001427 

Currently enrolling adults with resistant hypertension

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

Trials in Glomerulonephritis

A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome – CARDINAL study

Sponsor: Reata Pharmaceuticals, Inc.

ClinicalTrials.gov ID: NCT03019185

Site PI: Rasheed Gbadegesin

Currently enrolling patients with Alport Syndrome

The primary objective of the study is to assess the change from baseline in estimated glomerular filtration rate in bardoxolone methyl-treated patients and to assess the safety of bardoxolone methyl in patients with Alport Syndrome.  Bardoxolone methyl is a compound that activates Nrf2 and inhibits NF-κB, potentially reducing oxidative stress and inflammation. 

 

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: Bristol-Myers Squibb

Clinicaltrials.gov ID:  NCT02592798

Site PI: Rasheed Gbadegesin

Currently enrolling patients with 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 nephrotic syndrome due to either focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD). Abatacept will be administered by venous infusion every 4 weeks.

 

Pathogenesis of Goodpasture Syndrome

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.

Trials in Dialysis

Ascending-dose study of extracorporeal mesenchymal stromal cell therapy (SBI-101 Therapy) in subjects with Acute Kidney Injury receiving continuous renal replacement therapy

Sponsor: Sentien Biotechnologies, Inc.

ClinicalTrials.gov ID: NCT03015623

Site Co-Investigator: John Middleton

Currently enrolling patients in ICU with acute kidney injury receiving renal replacement therapy

This study is designed to assess the safety and tolerability of SBI-101, a hollow- fiber plasmapheresis unit, that incorporates human mesenchymal stromal cells to regulate inflammation and promote repair of injured tissue in subjects with acute kidney injury.

 

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

Sponsor: Christopher Granger

ClinicalTrials.gov ID: NCT02942407

Site PI: John Middleton

Currently enrolling patients on hemodialysis who have atrial fibrillation and end-stage renal disease

This is a multicenter study in adult patients with atrial fibrillation and end-stage renal disease who are on hemodialysis and who have stroke risk factors making them candidates for oral anticoagulation. Patients will be randomized to apixaban versus warfarin, and will be treated for up to 15 months. The objective of this study is 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.

 

Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study A (RADAR-A)

Sponsor: NIH/NHLBI

ClinicalTrials.gov ID: NCT03519347

Site PI: Patrick Pun

Currently enrolling patients with end-stage renal disease on dialysis

The primary purpose of this study is to test the feasibility of trials which change the dialysate (dialysis bath prescription) of potassium and bicarbonate according to a standardized algorithm and according to the results of blood testing performed prior to each dialysis. In addition, the trial will provide estimates of the extent to which performing dialysis in this way lowers the risk of abnormal heart rhythms in people with kidney failure who are being treated with chronic hemodialysis.

 

Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study B (RADAR-B)

Sponsor: NIH/NHLBI

ClinicalTrials.gov ID: NCT03519360

Site PI: Patrick Pun

Currently enrolling patients with end-stage renal disease on dialysis

The purpose of this study is to test the feasibility of trials that change the dialysis ultrafiltration rate by limiting the maximum rate and to estimate the extent to which limiting the ultrafiltration rate reduces the risk of abnormal heart rhythms in people with kidney failure who are being treated with chronic hemodialysis.

 

A Phase 3 Clinical Trial of Intravenous Sodium Thiosulfate in Acute Calciphylaxis Patients (CALISTA)

Sponsor: Hope Pharmaceuticals

ClinicalTrials.gov ID: NCT03150420

Site PI: Patrick Pun

Enroll will start soon. Patients with acute calciphylaxis-associated pain on chronic hemodialysis

Calciphylaxis is a rare disease characterized by abnormal calcification in soft tissues. Patients with calciphylaxis frequently develop painful skin lesions. The purpose of this study is to evaluate the efficacy and safety of intravenous Sodium Thiosulfate Injection for treatment of acute calciphylaxis-associated pain in chronic hemodialysis patients.

 

Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients Treated with Hemodialysis (PEARL-HD)

Sponsor: Relypsa

ClinicalTrials.gov ID:

Site PI: John Middleton

Enroll will start soon. Patients with end-stage renal disease on hemodialysis

The primary aim of the study is to determine whether once-daily dosing of patiromer will reduce the frequency of hyperkalemic episodes in ESRD patients who receive conventional hemodialysis.  A secondary aim is to examine whether patiromer will reduce the frequency of cardiac arrhythmias compared to usual care in ESRD patients who receive hemodialysis.

 

Integrated Mineral Metabolism Treatment Strategies in Patients with End-Stage Kidney Disease on Dialysis: A Qualitative Study

PI: Julia Scialla

Enrolling patients with end-stage renal disease on dialysis

The purpose of this study is to determine what is important to patients on dialysis and their care providers when treating mineral metabolism problems, like high phosphorus and parathyroid hormone levels.  Novel insights from this series of interviews will help our team design a clinical trial to study the best approaches to treat this problem.

 

Improving Quality of Life Measurement in Older Dialysis Patients

PI: Rasheeda Hall

Enrolling patients with end-stage renal disease 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 Kidney Disease and Quality of Life (KDQOL-36), and open-ended questions about life on dialysis.

Trials in Kidney Transplantation

Transplant Social Worker Support for Live Kidney Donation in African Americans (TALKS)

Sponsor: Duke University

Clinicaltrials.gov ID:  NCT02369354

Site PI: Matthew Ellis

Currently not recruiting

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.

 

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

Sponsor: Bristol-Myers Squibb

Clinicaltrials.gov ID:  NCT01820572

Site PI: Matthew Ellis

Currently not recruiting

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