A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy
Summary
This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics (PK) of obinutuzumab compared with tacrolimus in participants with primary membranous nephropathy (pMN).
Timeline
- Start
- 2021-06-25
- Primary completion
- 2025-12-22
- Completion
- 2027-12-21
Outcome
Met primary endpoint
paper Obinutuzumab was superior to tacrolimus in inducing complete remission in patients with primary membranous nephropathy. PMID 42246654 ↗
paper (37% vs. 6% with multiple imputation for missing data; adjusted difference, 31 percentage points; 95% CI, 18 to 44; P<0.001). PMID 42246654 ↗
release “MAJESTY, the first global Phase III study in primary membranous nephropathy, met its primary endpoint of complete remission at two years” gene.com ↗
release “The Phase III MAJESTY study met its primary endpoint with 36.9% of adults achieving complete remission (CR) at two years” gene.com ↗
Publications
- Fervenza FC, Hou FF, Hao CM, Kirsztajn GM, Gesualdo L, Hryszko T, Pisani A, Roccatello D, Bomback AS, Rae J, Barmaki F, Berisha E, Schindler T, Omachi TA, Garg JP, Malvar A; MAJESTY Trial Investigators. Obinutuzumab or Tacrolimus in Primary Membranous Nephropathy. N Engl J Med. 2026 Jun 5. doi: 10.1056/NEJMoa2602678. Online ahead of print.
- Dossier C, Bonneric S, Baudouin V, Kwon T, Prim B, Cambier A, Couderc A, Moreau C, Deschenes G, Hogan J. Obinutuzumab in Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome in Children. Clin J Am Soc Nephrol. 2023 Dec 1;18(12):1555-1562. doi: 10.2215/CJN.0000000000000288. Epub 2023 Sep 6.
- Dossier C, Hogan J. Response to Majeranowski. Pediatr Nephrol. 2021 Jun;36(6):1653. doi: 10.1007/s00467-021-04982-4. Epub 2021 Mar 10. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Obinutuzumab | Monoclonal antibody | 1000 mg | Intravenous |
| Comparator | Tacrolimus | Small molecule | — | Oral |
| Background | Acetaminophen | Small molecule | 650 mg | Oral |
| Background | Acetaminophen | Small molecule | 1000 mg | Oral |
| Background | Diphenhydramine | Small molecule | 50 mg | Oral |
| Background | Methylprednisolone | Other / unclassified | 80 mg | Intravenous |