Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy (MMFPRIMER)

Kyungpook National University

Status and phase: Unknown; Phase 3

Conditions: Glomerulonephritis, Membranous

Treatments: Drug: Mycophenolate mofetil, low dose steroid; Drug: Cyclosporin, low dose steroid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01282073

MMFPRIMER

Details and patient eligibility

About

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.

Full description

Idiopathic membranous nephropathy is most common cause of glomerulonephritis in adults. Persistent high grade proteinuria or progressively decrease of renal function is a risk factor for end stage renal disease in idiopathic membranous nephropathy. It has been reported that cyclosporin in patients with idiopathic membranous nephropathy decreases proteinuria and improve renal function. Mycophenolate mofetil is a recently developed immunosuppressive agent with fewer side effect than cyclosporin. In this study patients with high risk group of progressive idiopathic membranous nephropathy will be treated with mycophenolate mofetil and low dose prednisone. The outcome will be compared to controls treated with cyclosporin and low dose prednisone.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with idiopathic membranous nephropathy

2. The duration of disease is less than twelve months

3. Patients with persistent proteinuria more than 8 grams per day

4. Patients who provided informed consent

5. The cases that satisfy more than three of following items even if proteinuria is less than 8 grams per day:

   • eGFR < 60 ml/min/1.73m2
   • Hypertension (BP above 140/90mmHg or BP above 120/80 in patients taking anti-hypertensive agents)
   • 24 hours urine protein or spot urine protein/creatinine ratio > 5.0 g/day
   • Serum albumin (g/dL) < 3.0
   • Selectivity index > 0.2

Exclusion criteria

1. Severe digestive organ disease
2. Allergy history to clinical trial medication and acute or chronic allergy for 4 weeks recently.
3. Clinical history of treatment with other immunosuppressive medication
4. Probability of pregnancy, breast feeding woman
5. Uncontrolled hypertension (more than 160/100mmHg)
6. Uncontrolled systemic disease
7. Drug addiction or alcoholics within 6 months
8. eGFR is less than 30ml/min at screening
9. Abnormal liver function test (more than 3 times above compared with normal value)
10. Absolute neutrophil count <1,500/mm3 or leukocyte <2,500/mm3 or platelets <100,000/mm3
11. Secondary membranous nephropathy
12. Expected life expectancy is less than 1 year

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

62 participants in 2 patient groups

Mycophenolate mofetil, low dose steroid

Experimental group

Treatment:

Drug: Mycophenolate mofetil, low dose steroid

Cyclosporin, low dose steroid

Active Comparator group

Treatment:

Drug: Cyclosporin, low dose steroid