Phase 3
Completed N=130
MEmbranous Nephropathy Trial Of Rituximab
Idiopathic Membranous Nephropathy
Source: ClinicalTrials.gov NCT01180036 ↗
Enrolled (actual)
130
Serious AEs
23.8%
Results posted
Apr 2019
Primary outcomePrimary: Remission Status — 39; 13 Participants — p=0.001
◆ Published Evidence
Highly cited
603citations · ~86 / year
Rituximab or Cyclosporine in the Treatment of Membranous Nephropathy.
Summary
The primary outcome of this study is to determine whether or not the B cell targeting with Rituximab is non-inferior or more effective than Cyclosporine in inducing long term remission of proteinuria.
Linked Publications (4)
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Rituximab or Cyclosporine in the Treatment of Membranous Nephropathy.
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The genetic architecture of membranous nephropathy and its potential to improve non-invasive diagnosis.
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A Multicenter Randomized Controlled Trial of Rituximab versus Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy (MENTOR).
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Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Remission Status |
39; 34 | 0.009 sig |
| SECONDARY Remission Status |
39; 34 | 0.009 sig |
Eligibility Criteria
Inclusion Criteria
- Idiopathic MN with diagnostic biopsy
- Female, must be post-menopausal, surgically sterile or practicing a medically approved method of contraception(no birth-control pill)
- Must be off prednisone or mycophenolate mofetil for >1 month and alkylating agents for >6 months.
- angiotensin-converting-enzyme inhibitor (ACEi) and/or Angiotensin II receptor blockers (ARB), for >3 months prior to randomization and adequate blood pressure (target BP 75% of the readings, but subjects with BP 75% of the readings will be eligible). Patients with documented evidence of >3 months treatment with maximal angiotensin II blockade, on an 3-hydroxy-3-methylglutaryl-CoA lyase (HMG-CoA) reductase inhibitor, and BP control (BP 75% of the readings) who remain with proteinuria >5g/24h may enter and be randomized to RTX/CSA without the need of the run-in/conservative phase of the study.
- Proteinuria >5g/24h on two 24-hour urine collection collected within 14 days of each other
- Estimated glomerular filtration rate (GFR) ≥40 ml/min/1.73m2 while taking ACEi/ARB therapy OR quantified endogenous creatinine clearance >40 ml/min/1.73m2 based on a 24-hour urine collection.
Exclusion Criteria
- Presence of active infection or a secondary cause of MN (e.g. hepatitis B, systemic lupus erythematosus (SLE), medications, malignancies). Testing for HIV, Hepatitis B and C should have occurred <2 years prior to enrollment into the study.
- Type 1 or 2 diabetes mellitus: to exclude proteinuria secondary to diabetic nephropathy. Patients who have recent history of steroid induced diabetes but no evidence on renal biopsy performed within 6 months of entry into the study are eligible for enrollment.
- Pregnancy or breast feeding for safety reasons
- History of resistance to CSA (or other calcineurin inhibitors, e.g. tacrolimus), RTX or alkylating agents (e.g. Cytoxan). Patients who previously responded to CSA/Calcineurin Inhibitor (CNI), RTX or alkylating agents with either a complete remission (CR) or partial remission (PR) but relapsed off CSA/CNI after 3 months or relapsed off RTX or alkylating agent after 6 months are eligible.
Data sourced from ClinicalTrials.gov (NCT01180036) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.