With over 20 active trials, division scientists in the Nephrology Clinical Trials Unit are investigating the following topics:

Lupus Nephritis/SLE

Study Name: Divine
Title: Dynamic Imaging of Variation in Lupus Nephritis (“DIVINE”)
PI: Brad Rovin, MD
Sponsor: RLITE

Study Name: KZR-616 1/2b
Title: A Phase 1b/2 Study of KZR-616 in Patients with Systemic Lupus Erythematosus with and without Nephritis
PI: Samir Parikh, MD
Sponsor: Kezar

Study Name: BMS1107
Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis
PI: Samir Parikh, MD
Sponsor: Bristol Myers Squibb

Study Name: CFZ533
Title: A randomized, placebo-controlled, patient and investigator blinded study investigating the safety, tolerability, pharmacokinetics and preliminary efficacy of multiple doses of CFZ533 in patients with moderately active proliferative lupus nephritis
PI: Samir Parikh, MD
Sponsor: Novartis

FSGS

Study Name: ROBSO FSGS
Title: A phase 2, 12-week, adaptive, open label, sequential cohort trial to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06730512 following multiple doses in adult subjects with primary focal segmental glomerulosclerosis (FSGS)-
PI: Isabelle Ayoub, MD
Sponsor: Pfizer

Study Name: Voclosporin FSGS
Title: An Open-Label Dose-Exploration Cohort Study Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects with Focal Segmental Glomerulosclerosis
PI: Samir Parikh, MD
Sponsor: Aurinia

Study Name: Duplex
Title: A Randomized, multicenter, double-blind, parallel, active-control study of the effects of sparsentan, a dual endothelin receptor and angiotensin receptor blocker, on renal outcomes in patients with primary FSGS
PI: Isabelle Ayoub, MD
Sponsor: Retrophin

IGA

Study Name: 021GAN17001
Title: A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy
PI: Isabelle Ayoub, MD
Sponsor: Retrophin

Study Name: NEF-301 IgA
Title: A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary Iga Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd)
PI: Isabelle Ayoub, MD
Sponsor: Calliditas

Study Name: OMS721-IgA-001
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

Diabetic Nephropathy

Study Name: Trident
Title: Transformative Research In Diabetic Nephropathy
PI: Salem Almaani, MBBS
Sponsor: UPenn

C3

Study Name: CL011_168
Title: A Randomized, double-blind, placebo-controlled phase 2 study to evaluate the safety and efficacy of Avacopan (CCX168) in patients with C3 Glomerulopthy
PI: Samir Parikh, MD
Sponsor: ChemoCentryx, Inc.

Study Name: Achillion C3
Title: An Open-label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated with ACH-0144471
PI: Samir Parikh, MD
Sponsor: Achillion

CKD

Study Name: EMPA-KIDNEY
Title: EMPA-KIDNEY: A multicenter international randomized parallel group double-blind placebo-controlled clinical trial of EMPAgliflozin once daily to assess cardio-renal outcomes in patients with chronic KIDNEY disease
PI: Udayan Bhatt, MD
Sponsor: Boehringer Ingelheim

Registry

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

Study Name: CureGN
Title: Cohort consortium of glomerular disease patients followed prospectively with standardized clinical data and bio specimen collection
PI: Brad Rovin, MD
Sponsor: The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Name: LVG Registry
Title: Ohio State Lupus and Vasculitis Registry
PI: Stacy Ardoin, MD
Sponsor: Investigator Initiated

Study Name: ALN-LECT2
Title: A Study of the Natural History of Leukocyte Chemotactic Factor 2 Amyloidosis (ALECT2) Disease
PI: Samir Parikh, MD
Sponsor: Alnylam

Membranous

Study Name: REBOOT
Title: Anti-plasma cell antibody (cd38) primary MN
PI: Isabelle Ayoub, MD
Sponsor: ITN

Study Name: MOR202C103MN
Title: A Phase Ib/IIA, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (aMN)- M-Place
PI: Isabelle Ayoub, MD
Sponsor: Morphosys

Vasculitis

Study Name: INS1007
Title: Safety and Efficacy of INS1007, in the maintenance of remission in patients with Granulomatosis with Polyangiitis GPA
PI: Salem Almaani, MBBS
Sponsor: INSMED

PKD

Study Name: ADPK
Title: A 52-Week Phase 3, Double-blind, Placebo-Controlled, Randomized Study of the Efficacy and Safety of IP in Subjects with Autosomal Dominant Polycystic Kidney Disease
PI: Rima King, MD
Sponsor: Pharm-Olam

Kidney Stone

Study Name: ALLN-177-302
Title: Reloxaliase (ALLN-177)-142 mg of oxalate decarboxylase (equivalent to 3,750 units of enzyme activity) per capsule or matching placebo capsule
PI: Ganesh Shidham, MD
Sponsor: Allena