Primary IgA nephropathy is a glomerular disease characterized by mesangial deposition of IgA-containing immune complexes, leading to hematuria, proteinuria, and variable progression to chronic kidney disease.
Phase 3 trials demonstrate atrasentan slows kidney function decline in IgA nephropathy patients, while obinutuzumab achieves superior remission rates in primary membranous nephropathy compared to standard treatment.
Novartis announced final Phase III ALIGN results showing Vanrafia slowed kidney function decline in adults with IgA nephropathy, supporting planned submissions for traditional approval in 2026 following accelerated approvals in the U.S. and China in 2025.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07750249 |
The MIMIGA Study is a Randomized, Double-blind, Placebo-controlled Crossover Trial Evaluating the Safety and Efficacy of SCFA vs. Placebo. Administered Orally Once Daily With Standard Care, it Aims to Prevent CKD Progression in Biopsy-proven IgA Nephropathy by Modulating the Gut Microbiome. |
ENROLLING_BY_INVITATION | EARLY_PHASE1 |
| NCT07582133 |
A Trial to Evaluate the Long-term Safety and Tolerability of HRS-5965 in Patients With Primary IgA Nephropathy |
RECRUITING | PHASE2 |
| NCT07498673 |
A Study of YKST02 in Participants With Primary IgA Nephropathy |
RECRUITING | EARLY_PHASE1 |
| NCT07354932 |
A Study of SHR-2173 in Participants With Primary IgA Nephropathy |
RECRUITING | PHASE2 |
| NCT07014826 |
A Trial of HRS-5965 Capsule in Primary IgA Nephropathy |
RECRUITING | PHASE3 |
| NCT06982040 |
Evaluate the Efficacy and Safety of NTQ5082 Capsules in Patients With Primary IgA Nephropathy |
NOT_YET_RECRUITING | PHASE2 |
| NCT06589752 |
Replication of the NefIgArd Trial of TRF-budesonide in Primary IgAN |
COMPLETED | |
| NCT06137768 |
A Trial of HRS-5965 Tablets in Primary IgA Nephropathy |
COMPLETED | PHASE2 |
| NCT05847920 |
Efficacy and Safety of SHR-2010 Injection in the Treatment of Primary IgA Nephropathy |
TERMINATED | PHASE2 |
| NCT05799287 |
A Study of Telitacicept for IgA Nephropathy (TELIGAN) |
ACTIVE_NOT_RECRUITING | PHASE3 |
