Primary membranous nephropathy is an autoimmune glomerular disease, often associated with antibodies against podocyte antigens such as PLA2R, causing nephrotic syndrome and progressive proteinuric kidney injury.
Roche reported its Phase III MAJESTY study in primary membranous nephropathy met its primary endpoint with Gazyva/Gazyvaro, positioning the medicine as a potential first approved treatment for this rare kidney condition.
Obinutuzumab demonstrated superior efficacy in two separate phase 3 trials for systemic lupus erythematosus and primary membranous nephropathy, with statistically significant improvements in remission rates and disease response measures.
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.
The Phase III MAJESTY study met its primary endpoint, showing significantly more people achieved complete remission at two years with Gazyva versus tacrolimus. If approved, Gazyva would be the first therapy specifically indicated for primary membranous nephropathy.
Roche announced positive Phase III MAJESTY trial results showing Gazyva achieved significantly higher complete remission rates at two years versus tacrolimus in primary membranous nephropathy, with no new safety signals identified.
Roche announced that Gazyva/Gazyvaro met its primary endpoint in the Phase III MAJESTY study for primary membranous nephropathy, showing statistically significant complete remission rates versus tacrolimus. The drug could become the first approved therapy for this rare autoimmune kidney disease.
Genentech's Phase III MAJESTY study showed Gazyva achieved statistically significant complete remission rates versus tacrolimus in primary membranous nephropathy, a chronic autoimmune kidney disease affecting over 96,000 people in the U.S.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07571746 |
A Study to Assess the Effect of Surovatamig in Adult Participants With Antibody-mediated Kidney Disease |
RECRUITING | PHASE2 |
| NCT07289763 |
Phase II Randomized, Open-label, Multicenter Clinical Study Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of SHR-2173 Injection in Patients With Primary Membranous Nephropathy |
RECRUITING | PHASE2 |
| NCT07234474 |
A Phase I Study of YK012 in Primary Membranous Nephropathy |
NOT_YET_RECRUITING | PHASE1 |
| NCT07204275 |
Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN) |
RECRUITING | PHASE2/PHASE3 |
| NCT07157787 |
Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN) |
RECRUITING | PHASE2 |
| NCT07096843 |
A Phase 2 Study of Budoprutug in Subjects With Primary Membranous Nephropathy |
RECRUITING | PHASE2 |
| NCT07029139 |
A Study to Learn More About the Effects and Safety of JMT601 in Adults With Primary Membranous Nephropathy |
NOT_YET_RECRUITING | PHASE2 |
| NCT06982729 |
Study of YK012 in Primary Membranous Nephropathy |
RECRUITING | PHASE1 |
| NCT06962800 |
A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN) |
RECRUITING | PHASE3 |
| NCT06924476 |
Optimization of a Decision Formula for Optimal Timing of Immunosuppressive Therapy Initiation in Primary Membranous Nephropathy: A Multicenter Retrospective Cohort Study |
ACTIVE_NOT_RECRUITING |
