Clinical Trials

The Division of Nephrology is actively participating in several clinical trials in both general nephrology and transplant nephrology. All current clinical trials are listed below.

General Nephrology

SIRIUS-LN | Safety, Efficacy, and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

Description | A Phase 3, Randomized, Double-blind, Parallel Group, Placebo-Controlled, trial to evaluate the efficacy, safety and tolerability of Ianalumab (VAY736) on top of standard-of-care therapy in participants 18 years or older with active lupus nephritis.

• Principal Investigator | Manish Anand, MD
• Indication | Lupus Nephritis
• Sponsor | Novartis

ALMOND | A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults with Primary Membranous Nephropathy

Description | A Phase 3, Multicenter, Randomized, Active-Controlled, Open-Label study to evaluate the efficacy and safety of Zanubrutinib in patients with primary membranous nephropathy.

• Principal Investigator | Manish Anand, MD
• Indication | Primary Membranous Nephropathy
• Sponsor | BeiGene

BEYOND | A Study of Zigakibart in Adults with IgA Nephropathy

Description | A Phase 3, Randomized, Double-Blind, Placebo-Controlled study of Zigakibart in adults with IgA nephropathy

• Principal Investigator | Manish Anand, MD
• Indication | IgA Nephropathy
• Sponsor | Chinook

AMPLITUDE | A Study of Inaxaplin in Participants With Proteinuric APOL1 Mediated Kidney Disease

Description | A Phase 2b, Open-label, Study of Inaxaplin in participants with Proteinuric APOL1 mediated kidney disease

• Principal Investigator | Prakash Gudsoorkar, MD
• Indication | APOL1-mediated Proteinuric Kidney Disease
• Sponsor | Vertex

ORIGIN | A Study Evaluating Effect of Atacicept vs Placebo on Proteinuria and Renal Function Preservation in IgAN

Description | Phase 2b/3, Multipart, Randomized, Double-blind, Placebo-controlled study evaluating effect of Atacicept vs placebo on Proteinuria and renal function preservation in IgAN

• Principal Investigator | Ahmad Anjak, MD
• Indication | IgANephropathy
• Sponsor | Vera

Transplant Nephrology

APPELHUS | A Trial to Evaluate Efficacy and Safety of Oral, Twice Daily LNP023 in Adult aHUS Patients Who Are Naïve to Complement Inhibitor Therapy.

Description | A Phase 3, Multicenter, Single-arm, Open Label study to demonstrate the efficacy and safety of LNP023 (iptacopan) at a dose of 200 mg b.i.d. in adult patients with aHUS who are treatment naive to complement inhibitor therapy (including anti-C5 antibody).

• Principal Investigator | Amit Govil, MD
• Indication | Atypical Hemolytic Uremic Syndrome
• Sponsor | Novartis

ASCEND | A Study of TCD601 in de Novo Renal Transplant Recipients

Description | A 12-Month, Randomized, Open-Label, Phase IIA study evaluating the safety and efficacy of Siplizumab in combination with Belatacept and MPA compared to standard of care immunosuppression in de Novo renal transplant recipients

• Principal Investigator | E. Steve Woodle, MD
• Indication | Kidney Transplant Recipient
• Sponsor | ITB-Med LLC

CareDx Kidney | Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry (KOAR)

Description | An observational study to evaluate safety and efficacy outcomes in renal transplant recipients in whom post-transplant care is managed using AlloSure®

• Principal Investigator | Amit Govil, MD
• Indication | Kidney Transplant Recipient
• Sponsor | CareDx

EFFEKTOR | The Effect of Finerenone in Kidney Transplantation Recipients

Description | A Vanguard, Multicenter, Phase-2 Randomized, Double-Blind, Placebo Controlled clinical trial to determine the feasibility, tolerability, safety, and efficacy of finerenone in kidney transplant recipients (KTRs)

• Principal Investigator | Amit Govil, MD
• Indication | Kidney Transplant Recipient
• Sponsor | University of North Carolina, Chapel Hill

TRANSCEND | A Trial of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)

Description | A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 3 Trial evaluating the efficacy and safety of Felzartamab in kidney transplant recipients With late antibody-mediated rejection (AMR)

• Principal Investigator | E. Steve Woodle, MD
• Indication | Kidney Transplant Recipient With Late Antibody-Mediated Rejection
• Sponsor | HI-Bio, A Biogen Company