Clinical Trials

The purpose of this study is to assess the effectiveness, safety and pharmacokinetic (PK)/pharmacodynamic (PD) relationship of the human anti-CD38 antibody Felzartamab in patients with IgA Nephropathy (IgAN) at risk for progression.

This study is designed to answer whether patients with progressive IgA nephropathy, who receive Acthar (ACTH) gel injection at a dose of 80 units subcutaneously twice weekly for 6 months is effective in inducing improvement in proteinuria and renal function.

Recent clinical success in the use of Rituximab in the treatment of Lupus nephritis and other forms immune complex glomerulonephritis has led to its investigation in the treatment of IgA nephropathy. Because IgA class antibodies have comparatively short half-lives and that deposition of polymeric forms of IgA contributes to glomerular injury, we speculate that the reduction of circulating IgA may reduce proteinuria and injury in patients with IgA nephropathy. Moreover, the absence of prospective trials in the treatment of IgA disease and the lack of consensus for long-term treatment, the superior side-effect profile of this form of therapy may lead ...

The purpose of this study is to evaluate effects on proteinuria and glomerular filtration rate of sibeprenlimab 400 mg subcutaneously (s.c.) Q 4 weeks in adults with IgAN who are receiving maximally tolerated standard-of-care therapy.

The purpose of this study is to understand the pathogenesis of IgAN disease by investigating the biology of dendritic cells, major antigen-presenting cells, and B cells that produce antibody, but also are capable of suppressing immune responses.

This is a phase 2/3 open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) in subjects with IgAN.

The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan 200 mg b.i.d. in primary IgA nephropathy adult participants who have completed one of the Novartis-sponsored parent studies in IgAN with biopsy-confirmed IgAN, an eGFR ≥ 20 mL/min/1.73m2 and per Investigator’s clinical judgement may benefit from receiving open-label iptacopan, despite optimal supportive treatment

The purpose of this study is to evaluate effects on proteinuria and glomerular filtration rate of sibeprenlimab 400 mg subcutaneously (s.c.) Q 4 weeks in adults with IgAN who are receiving maximally tolerated standard-of-care therapy.

The study is designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of iptacopan (LNP023) at a dose of 200 mg b.i.d. compared to placebo on top of maximally tolerated ACEi or ARB on reduction of proteinuria and slowing renal disease progression in primary IgA Nephropathy patients.

The purpose of this study is to evaluate the safety and effectiveness of OMS721 in patients with IgA nephropathy. The study will assess proteinuria by 24-hour urine protein excretion (UPE) in g/day at 36 weeks from beginning of treatment.

The purose of this study is to evaluate the effectiveness, safety, and tolerability of Nefecon 16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy) at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment with renin-angiotensin system (RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).

The purpose of this study is to develop urine tests that will measure biological markers and use them to track the status of kidney disease. This test may help doctors to better care for patients with kidney disease.

The purpose of this registry is to establish a database of patients diagnosed with minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), membranous nephropathy (MN), or immunoglobulin A nephropathy (IgAN), to advance the diagnosis and care of patients with glomerular diseases.

This study is being done to create a "resource" of samples that can be used to improve our ability to diagnose and treat MN, IgAN, MPGN, FSGS/MCD, Lupus Nephritis, AAV, other glomerular tubulo-interstitial disease.