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NCT04629248: MAJESTY
A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy
Phase 3 trial testing Obinutuzumab in Primary Membranous Nephropathy in 142 participants. Participants enrolled and being followed up; not accepting new ones.
22 December 2025
Quick facts
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 142 |
| Start date | 25 June 2021 |
| Primary completion | 22 December 2025 |
| Estimated completion | 21 December 2027 |
| Sites | 50 locations across France, Italy, Russia, Israel, Poland, Argentina, China, Spain |
Drugs / interventions tested
- Obinutuzumab — full drug profile →
- Tacrolimus
- Methylprednisolone (methylprednisolone) — full drug profile →
- Acetaminophen (Paracetamol) — full drug profile →
- Diphenhydramine (diphenhydramine) — full drug profile →
Conditions studied
- Primary Membranous Nephropathy — all drugs for Primary Membranous Nephropathy →
Sponsor
Hoffmann-La Roche — full company profile →
Who can join
Adults 18 to 75, any sex, with Primary Membranous Nephropathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics (PK) of obinutuzumab compared with tacrolimus in participants with primary membranous nephropathy (pMN).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Obinutuzumab in Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome in Children.
Dossier C, Bonneric S, Baudouin V, Kwon T, et al · · 2023 · cited 42× · PMID 37678236 · DOI 10.2215/cjn.0000000000000288 -
Novel Treatments Paradigms: Membranous Nephropathy.
Rojas-Rivera JE, Ortiz A, Fervenza FC. · · 2023 · cited 37× · PMID 36938069 · DOI 10.1016/j.ekir.2022.12.011 -
Implications of rituximab pharmacokinetic and pharmacodynamic alterations in various immune-mediated glomerulopathies and potential anti-CD20 therapy alternatives.
Hartinger JM, Kratky V, Hruskova Z, Slanar O, et al · · 2022 · cited 30× · PMID 36420256 · DOI 10.3389/fimmu.2022.1024068 -
Treatment resistant M-type phospholipase A2 receptor associated membranous nephropathy responds to obinutuzumab: a report of two cases.
Hudson R, Rawlings C, Mon SY, Jefferis J, et al · · 2022 · cited 26× · PMID 35392837 · DOI 10.1186/s12882-022-02761-3 -
Future landscape for the management of membranous nephropathy.
Caravaca-Fontán F, Yandian F, Fervenza FC. · · 2023 · cited 21× · PMID 37529655 · DOI 10.1093/ckj/sfad041 -
Recent Clinical Trials Insights into the Treatment of Primary Membranous Nephropathy.
Rojas-Rivera J, Fervenza FC, Ortiz A. · · 2022 · cited 21× · PMID 34932208 · DOI 10.1007/s40265-021-01656-1 -
Obinutuzumab as Initial or Second-Line Therapy in Patients With Primary Membranous Nephropathy.
Su X, Wu B, Tie X, Guo X, et al · · 2024 · cited 19× · PMID 39156138 · DOI 10.1016/j.ekir.2024.05.004 -
Obinutuzumab and Ofatumumab are More Effective Than Rituximab in the Treatment of Membranous Nephropathy Patients With Anti-Rituximab Antibodies.
Teisseyre M, Allinovi M, Audard V, Cremoni M, et al · · 2025 · cited 12× · PMID 40225374 · DOI 10.1016/j.ekir.2024.12.012
Verify or expand the search:
- PubMed search for NCT04629248
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Primary Membranous Nephropathy
Currently open trials in the same condition.
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- NCT06962800 — A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropath · Phase 3 · recruiting
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- NCT06893328 — A Real World Study About PMN · recruiting
Other Hoffmann-La Roche trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04629248 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
- Last refreshed: 7 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04629248.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing