Nephrology Clinical Trials and Other Human Subject Research Seeking Enrollment at Duke
We are currently conducting trials in each of these areas:
Contact John P. Middleton, MD if you are interested in more information
Updated: April 2023
Trials in Chronic Kidney Disease
Community APOL1 Research Engagement (CARE)
Sponsor: National Institutes of Health (NIH)
ClinicalTrials.gov ID: NCT05237388
PI: Opeyemi Olabisi
Currently enrolling
The purpose of this project is to increase the awareness of APOL1-mediated kidney disease. This is achieved through community engagement and screening for kidney disease (urine- and blood-based tests) and screening for kidney disease-causing APOL1 gene (saliva-based test). Individuals found to have APOL1-associated kidney disease will have the opportunity to participate in a clinical trial seeking a cure.
See more information on this study
Diet and Hypertension Management in African Americans with Chronic Kidney Disease
Sponsors: National Institutes of Health (NIH)/Duke Endowment
ClinicalTrials.gov ID: NCT04084574
PI: Crystal Tyson
Currently enrolling
Aim 1: To identify barriers and facilitators of adherence to the Dietary Approaches to Stop Hypertension (DASH) dietary pattern among African Americans with chronic kidney disease (CKD).
Aim 2: To develop and pilot test the effectiveness of a culturally-sensitive and disease-relevant counseling intervention to lower blood pressure (BP) in African Americans with CKD.
Duke ApoL1 Nephropathy Biorepository (DARB)
Sponsors: Duke University/National Institutes of Health (NIH)
ClinicalTrials.gov ID: NCT04160507
PI: Opeyemi Olabisi
Currently enrolling
The goal of this study is to discover how two common changes in the APOL1 gene cause kidney disease in some people while other carriers of the gene are protected. The study seeks African American/Black adults with non-diabetic kidney failure (FSGS). Participation involves a onetime donation of a tablespoon of blood for research.
Janus kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease
Sponsor: National Institutes of Health (NIH)
ClinicalTrials.gov ID: NCT05237388
PI: Opeyemi Olabisi
Currently enrolling
The goal of this Phase 2 clinical trial is to evaluate the efficacy and safety of Baricitinib to reduce albuminuria in African American/Blacks with APOL1-associated FSGS and APOL1-associated CKD due to hypertension (HTN-CKD).
See more information on this study
Trials in Hypertension
Trials in Glomerulonephritis
Community APOL1 Research Engagement (CARE)
Sponsor: National Institutes of Health (NIH)
ClinicalTrials.gov ID: NCT05237388
PI: Opeyemi Olabisi
Currently enrolling
The purpose of this project is to increase the awareness of APOL1-mediated kidney disease. This is achieved through community engagement and screening for kidney disease (urine- and blood-based tests) and screening for kidney disease-causing APOL1 gene (saliva-based test). Individuals found to have APOL1-associated kidney disease will have the opportunity to participate in a clinical trial seeking a cure.
See more information on this study
Duke ApoL1 Nephropathy Biorepository (DARB)
Sponsors: Duke University/National Institutes of Health (NIH)
ClinicalTrials.gov ID: NCT04160507
PI: Opeyemi Olabisi
Currently enrolling
The goal of this study is to discover how two common changes in the APOL1 gene cause kidney disease in some people while other carriers of the gene are protected. The study seeks African American/Black adults with non-diabetic kidney failure (FSGS). Participation involves a onetime donation of a tablespoon of blood for research.
Janus kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease
Sponsor: National Institutes of Health (NIH)
ClinicalTrials.gov ID: NCT05237388
PI: Opeyemi Olabisi
Currently enrolling
The goal of this Phase 2 clinical trial is to evaluate the efficacy and safety of Baricitinib to reduce albuminuria in African American/Blacks with APOL1-associated FSGS and APOL1-associated CKD due to hypertension (HTN-CKD).
See more information on this study
Trials in Dialysis
A Prospective, RanDomized, Multi-Center, Open-Label, Cross-Over Study of Sodium Zirconium Cyclosilicate to Control Interdialytic HyperkalemiA Following Augmentation of Dialysate Potassium: Efficacy to Reduce the Incidence of Post-Dialysis Atrial Fibrillation and Clinically SignificanT Cardiac Arrhythmias - ADAPT Trial
Sponsors: NephroNet, Inc./AstraZeneca
PI: John Middleton
Currently enrolling
The overall aim of the study is to determine whether converting stable dialysis subjects from a “standard” regimen (without Lokelma) to a different experimental dialysis regimen including Lokelma, to treat high potassium during dialysis, will reduce the number of times a person has atrial fibrillation.
Deprescribing for Older Dialysis Patients
Sponsors: Duke University/NIH
ClinicalTrials.gov ID: NCT03631290
PI: Rasheeda Hall
Currently enrolling
The purpose of the proposed research is to acquire evidence to inform an evidence-based strategy to reduce inappropriate prescribing in older dialysis patients. The research aims are to: 1) identify elements of a deprescribing intervention that are acceptable to nephrologists, primary care providers, pharmacists, dialysis staff, and patients, and 2) determine the feasibility of a deprescribing intervention tailored for older dialysis patients.
*Patients are approached for participation if their dialysis clinicians supports deprescribing the medication
Novel Mechanisms and Therapeutic Targets for Pulmonary Hypertension in End-Stage Kidney Disease (PH-ESKD)
Sponsor: National Institutes of Health (NIH)
PI: Daniel Edmonston
Currently enrolling
The objective of this study is to determined how select risk factors which affect vascular biology associate with the risk, severity, and progression of pulmonary hypertension (PH) in persons with ESKD.
Trials in Kidney Transplantation
CardioRenal Effects of SGLT2 inhibition in Kidney Transplant recipients (CREST-KT)
Sponsors: Haller Foundation/Boehringer Ingelheim
Clinicaltrials.gov ID: NCT04906213
PI: Myles Wolf
Currently enrolling
CREST-KT is a single-center, double-blinded, randomized trial to determine safety and efficacy of Empagliflozin therapy in kidney transplant recipients with and without type 2 diabetes in improving clinical parameters of eGFR, albuminuria, cardiac structure and function, and insulin sensitivity.