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 Pharmaceutical
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
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
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: 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
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
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
Study Type: Interventional
Study Name: Lupkynis
Title: A Prospective Observational Registry of Patients Treated with LUPKYNIS (voclosporin) in the US
PI: Isabelle Ayoub, MD
Sponsor: Aurinia Pharmaceuticals
Study Type: Observational
Study Name: HiBio
Title: An Open Label Phase 1b Study of Felzartamab in Lupus Nephritis
PI: Isabelle Ayoub, MD
Sponsor: Hi-Bio
Study Type: Interventional
Study Name: Kezar
Title: A Phase 2b, Randomized, Controlled Double-blind, Multicenter Study Comparing the Efficacy and Safety of Zetomipzomib (KZR-616) 30 mg or 60 mg with Placebo in Patients with Active Lupus Nephritis
PI: Samir Parikh, MD
Sponsor: Kezar Life Sciences
Study Type: Interventional
Study Name: Kyverna
Title: A Phase 1, Open-Label, Multicenter Study of KYV-101, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Lupus Nephritis
PI: Isabelle Ayoub, MD
Sponsor: Icon Clinical RES
Study Type: Interventional
Study Name: LockiT
Title: Identification and Molecular Characterization of Incipient Lupus Nephritis: Lupus Omics Cutaneous Kidney Investigative Team, Kidney Project 1
PI: Brad Rovin,MD
Sponsor: NIH
Study Type: Registry
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