Phase 3
N=39
Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy
Glomerulonephritis, Membranous
Bottom Line
View on ClinicalTrials.gov: NCT01282073 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Percentage of Complete Remission — 4; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Mycophenolate mofetil, low dose steroid (Drug); Cyclosporin, low dose steroid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kyungpook National University Hospital
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Complete Remission |
4; 3 | — |
| PRIMARY Percentage of Partial Remission |
12; 9 | — |
| SECONDARY Estimated Glomerular Filtration Rate (eGFR) |
— | — |
| SECONDARY Relapse |
— | — |
| SECONDARY Proteinuria |
— | — |
| SECONDARY Side Effects |
— | — |
Summary
Cyclosporin decreases proteinuria and improve renal function in patients with idiopathic membranous nephropathy, but has a risk of side effects such as nephrotoxicity. The investigators plan to the study to evaluate whether mycophenolate mofetil (MMF) could be a reasonable alternative with fewer side effect.
Eligibility Criteria
Inclusion Criteria
- Patients with idiopathic membranous nephropathy
- The duration of disease is less than twelve months
- Patients with persistent proteinuria more than 8 grams per day
- Patients who provided informed consent
- The cases that satisfy more than three of following items even if proteinuria is less than 8 grams per day:
- eGFR 5.0 g/day
- Serum albumin (g/dL) 0.2
Exclusion Criteria
- Severe digestive organ disease
- Allergy history to clinical trial medication and acute or chronic allergy for 4 weeks recently.
- Clinical history of treatment with other immunosuppressive medication
- Probability of pregnancy, breast feeding woman
- Uncontrolled hypertension (more than 160/100mmHg)
- Uncontrolled systemic disease
- Drug addiction or alcoholics within 6 months
- eGFR is less than 30ml/min at screening
- Abnormal liver function test (more than 3 times above compared with normal value)
- Absolute neutrophil count <1, 500/mm3 or leukocyte <2,500/mm3 or platelets <100,000/mm3
- Secondary membranous nephropathy
- Expected life expectancy is less than 1 year
Data sourced from ClinicalTrials.gov (NCT01282073). 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.