Research

The Division of Nephrology and Hypertension at East Carolina University is involved in clinical and translational research. Research areas include hypertension, diabetes, Chronic Kidney Disease (CKD), End Stage Renal Disease (ESRD), and Kidney Transplantation.

Through new discoveries in the renal research we strive to improve the quality of care for our patient population. Our research has not only allowed us to escalate our knowledge but also to extend the knowledge available in the literature.

For more information regarding our studies, please contact our research staff at 252-744-0671 or nephrologyresearch@ecu.edu

Current Projects

CURRENT CLINICAL TRIALS

Title:    A Phase 1b/2a Study of VB119 in Adult Subjects with Primary Membranous Nephropathy

• Principal Investigator: Reginald Obi, MD
• Funded by: ValenzaBio, Inc.
• Open to Enrollment

This study is a Phase 1b/2a, open‑label, sequential-cohort, dose escalation, and dose expansion study to evaluate the safety, tolerability, PK, and PD of VB119 in subjects with primary MN.

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Title:    A Randomized Parallel-group, Placebo-controlled, Double-blind, Event-driven, Multi-center Phase 2 Clinical Outcome Trial of Prevention of Arteriovenous Graft Thrombosis and Safety of MK-2060 in Patients with End Stage Renal Disease Receiving Hemodialysis

• Principal Investigator: Cynthia Christiano, MD
• Funded by: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
• Open to Enrollment

The purpose of this study is to evaluate the efficacy and safety of MK-2060 in ESRD participants receiving hemodialysis via an arteriovenous graft.
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Title:  A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Phase 3 Study to Investigate the Efficacy and Safety of FInerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Patients with Non-Diabetic Chronic Kidney Disease (FIND-CKD)

• Principal Investigator: Cynthia Christiano, MD
• Funded by: Bayer HealthCare Pharmaceuticals Inc.
• Open to Enrollment

The purpose of this study is to investigate the efficacy and safety of finerenone, i.e., 10 mg and 20 mg once daily, compared with placebo, on the progression of non-diabetic chronic kidney disease in male and female patients over 18 years of age, over minimum of 32-months of study intervention per participant, in addition to standard of care.
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Title:  A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Zilebesiran Used as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2)

• • Principal Investigator: Paul Bolin, MD
  • Funded by: Alnylam Pharmaceuticals, Inc.
  • Open to Enrollment

The primary objective of this study is to evaluate the add-on effect of zilebesiran on systolic blood pressure as assessed by 24 hour ambulatory blood pressure monitoring at Month 3 for each protocol-specified background antihypertensive medication (olmesartan, amlodipine, or indapamide).
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Title:  A Phase 2 Study of VB119 in Adult Subjects with Steroid-Sensitive Primary Minimal Change Disease or Primary Focal Segmental Glomerulosclerosis

• Principal Investigator: Reginald Obi, MD
• Funded by: ValenzaBio, Inc.
• Open to Enrollment

The primary efficacy objective is to assess the efficacy of VB119 on maintenance of remission defined as ˂0.5 g/g urine protein/creatinine ratio (UPCR) in subjects with Minimal Change Disease or Primary Focal Segmental Glomerulosclerosis who are corticosteroid-dependent or frequently relapsing.

COLLABORATIVE RESEARCH STUDIES

Title: Trial to Assess Chelation Therapy (TACT2)

• Principal Investigator: James R. Powell, MD  (General Internal Medicine)
• Funded by: National Institute of Health, Mount Sinai Medical Center
• Closed to Enrollment

A randomized, double blind controlled factorial clinical trial of edetate disodium-based chelation and high-dose oral vitamins and minerals to prevent recurrent cardiac events in diabetic patients with a prior myocardial infarction.

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Title:  Efficacy and safety of GMRx2 (a single pill combination containing telmisartan/amlodipine/indapamide) compared to dual combinations for the treatment of hypertension. (GMRx2-HTN-2020-ACT1)

• Principal Investigator: James R. Powell, MD (General Internal Medicine)
• Funded by: George Medicines Pty Limited
• Open to Enrollment

The purpose of this study is to investigate the efficacy and safety of GMRx2 compared to the three dual combinations of the component drugs for the treatment of hypertension.

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Title:    Aspirin in Reducing Events in the Elderly – eXTension (ASPREE-XT)

• Principal Investigator: James R. Powell, MD
• Funded by: Hennepin Health Care
• Closed to Enrollment

ASPREE-XT is a post-treatment, longitudinal observational follow-up study of ASPREE participants to enable the monitoring of possible delayed effects of aspirin treatment, primarily on cancer incidence, metastasis, and mortality.

INVESTIGATOR-INITIATED STUDIES

Title:  Glomerulonephritis Database

• Principal Investigator: Reginald Obi, MD
• Unfunded
• Open to Enrollment

The purpose of this database is to collect clinically relevant information from the electronic medical record of patients undergoing a native kidney biopsy from January 2003 to the present in order to evaluate the prevalence of glomerulonephritis, its management and subsequent kidney specific follow up outcomes.

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Title:  COVID-19 Acute Kidney Injury Risks and Outcomes in Eastern North Carolina

• Principal Investigator: Hsiao Lai, MD
• Unfunded
• Open to Enrollment

The aim of this project is to review the Vidant Electronic Health Record of patients hospitalized from March 2020 to October 2020 with SarsCoV-2 infection and renal involvement to determine the impact on morbidity and mortality, the risk factors for severe or persistent renal injury and to identify the management strategies  associated with better renal outcomes.
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Title:  Hemodialysis Adherence Survey

• Principal Investigator: Hsaio L. Lai, MD
• Unfunded
• Open to Enrollment

The intent of this study is to identify specific factors associated with in-center hemodialysis non-adherence.  Dialysis non-adherence is associated with worse outcomes including increased mortality, ER visits, and hospital and ICU admissions.

Publications

Resources

National Kidney Foundation

The National Kidney Foundation is the leading organization in the U.S. dedicated to the awareness, prevention and treatment of kidney disease for hundreds of thousands of healthcare professionals, millions of patients and their families, and tens of millions of Americans at risk.