Clinical Trials

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

Updated: August, 2020

Trials in Chronic 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.

 

 

Trials in Dialysis

HiLo: Pragmatic Trial of Higher vs Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis

Sponsor: NIH/NIDDK

ClinicalTrials.gov ID: NCT04095039

PI: Myles Wolf

Currently enrolling patients with end-stage renal disease on dialysis

HiLo study will be a pragmatic, open-label, multicenter, cluster-randomized trial of ~4400 patients with ESRD undergoing in-center maintenance hemodialysis at 120-150 units maintained by two dialysis organizations that care for a substantial proportion of the US dialysis population.

 

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.

 

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

Sponsor: Relypsa

ClinicalTrials.gov ID: NCT03781089

Site PI: John Middleton

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.

 

Deprescribing for Older Dialysis Patients

Sponsor: Duke University/NIH

ClinicalTrials.gov ID:  NCT03631290

PI: Rasheeda Hall

Patients with end-stage renal disease on hemodialysis (Not yet enrolling)

Older adults receiving dialysis are often prescribed multiple medications. Some of these medications are used to treat symptoms, but they also can increase the chance of significant health problems. The purpose of this study is to identify if it is feasible to reduce the use of medications that have been identified as causing an increased risk for health problems.

 

 

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.