Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyungpook National University; Kyungpook National University Hospital
• Collaborator: Hanmi Pharmaceutical Company Limited
• Treatments: Cyclosporine; Cyclosporins; Mycophenolate mofetil; Mycophenolic Acid

Criteria

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