Improving patients' lives through research

At The Ohio State University Division of Nephrology, our team conducts basic, translational and clinical research for diseases that affect the kidney and the consequences of kidney failure.

For questions or for more information, contact us at nephrologyresearch@osumc.edu.

Clinical Trials 

With over 15 active trials, division scientists in the Nephrology Clinical Trials Unit are investigating the following topics:

Alport Syndrome

Study Name: R3R01
Title: A Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in Alport Syndrome Patients with Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients with Primary Steroid-Resistant Focal Segmental Glomerulosclerosis (R3R01-ASFSGS-201)
PI: Isabelle Ayoub, MD
Sponsor: River 3 Renal Corp
Study Type: Interventional

APOL1-Mediated Kidney Disease

Study Name: Vertex 301
Title: A Phase 2/3 Adaptive, Double-blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Subjects Aged 18 Years and Older With APOL1-mediated Proteinuric Kidney Disease
PI: Sethu Madhavan, MD
Sponsor: Vertex Pharmaceuticals Incorporated
Study Type: Interventional

Diabetic Nephropathy

Study Name: Trident
Title: Transformative Research In Diabetic Nephropathy
PI: Salem Almaani, MBBS
Sponsor: Boehringer Ingelheim, Glaxo Smith Kline, Regeneron, Gilead Sciences, Novo Nordisk, Juvenile Diabetes Research Foundation
Study Type: Registry

Study Name: CureGN-DM
Title: CureGN – Diabetes
PI: Salem Almaani, MBBS
Sponsor: National Institutes of Health – The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Type: Registry

Fabry Disease

Study Name: Fabry Disease Registry
Title: Fabry Disease Registry Protocol
PI: Isabelle Ayoub, MD
Sponsor: Sanofi Genzyme
Study Type: Registry

Study Name: Amicus
Title: A Retrospective Characterization of Patients with Amenable GLA Variants Being Treated for Fabry Disease
PI: Isabelle Ayoub, MD
Sponsor: Amicus Therapeutics, Inc
Study Type: Registry

FSGS

Study Name: BIPI 1434
Title: Boehringer Ingelheim Pharmaceuticals, Inc. / “A multicenter, randomized, double-blind, parallel group, placebo-controlled study to assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics profile of BI 764198 administered orally once daily for 12 weeks in patients with focal segmental glomerulosclerosis.”
PI: Isabelle Ayoub, MD
Sponsor: Boehringer Ingelheim Pharmaceuticals, Inc.
Study Type: Interventional

Study Name: R3R01
Title: A Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in Alport Syndrome Patients with Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients with Primary Steroid-Resistant Focal Segmental Glomerulosclerosis (R3R01-ASFSGS-201)
PI: Isabelle Ayoub, MD
Sponsor: River 3 Renal Corp
Study Type: Interventional

IgA

Study Name: Omeros IgA
Title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (Artemis-IGAN)
PI: Isabelle Ayoub, MD
Sponsor: Omeros Corporation
Study Type: Interventional

Study Name: Otsuka-IgA-Phase 3
Title: Otsuka Pharmaceutical Development & Commercialization, Inc. / “A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy”
PI: Isabelle Ayoub, MD
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc
Study Type: Interventional

Study Name: Otsuka-IgA-OLE
Title: Otsuka Pharmaceutical Development & Commercialization, Inc. / “A Phase 2/3 Multicenter, Open-label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy”
PI: Isabelle Ayoub, MD
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc
Study Type: Interventional

Lupus Nephritis/SLE

Study Name: Alexion
Title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
PI: Samir Parikh, MD
Sponsor: Alexion Pharmaceuticals, Inc
Study Type: Interventional

Membranous

Study Name: REBOOT
Title: Efficacy of Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy
PI: Isabelle Ayoub, MD
Sponsor: National Institutes of Allergy and Infectious Diseases (NIAID)
Study Type: Interventional

Multiple Disease Registries

Diseases: Minimal Change Disease (MCD), FSGS, Membranous Nephropathy or IgA
Study Name: CureGN
Title: CureGN: Cure Glomerulonephropathy Network
PI: Brad Rovin, MD
Sponsor: National Institutes of Health – The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NephCure Kidney International
Study Type: Registry

Diseases: Minimal Change Disease (MCD), FSGS, Membranous Nephropathy or Alport Syndrome
Study Name: Neptune
Title: The Nephrotic Syndrome Study Network (Neptune)
PI: Salem Almaani, MBBS
Sponsor: Office of Rare Diseases, National Institutes of Health – The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NephCure Kidney International, Department of Health and Human Services (DHHS), The University of Michigan
Study Type: Registry