Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy

Phase 3

• Conditions: Glomerulonephritis, Membranous
• Interventions: Drug: Mycophenolate mofetil, low dose steroid; Drug: Cyclosporin, low dose steroid

• Registration Number: NCT01282073
• Lead Sponsor: Kyungpook National University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2011-01-19
• Study First Submitted QC: 2011-01-21
• Study First Posted: 2011-01-24
• Study Start: 2011-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-04-10
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mycophenolate mofetil, low dose steroid	Mycophenolate mofetil, low dose steroid	-
Cyclosporin, low dose steroid	Cyclosporin, low dose steroid	-

Primary Outcome Measures

Name	Time	Method
Percentage of complete remission	at 48 week after treatment	Complete remission: Reduction in proteinuria to 200 mg per day with stable serum albumin with more than 3.5 g/dL
Percentage of partial remission	at 48 week after treatment	Partial remission: Reduction in proteinuria to greater than 50 percent of initial values or absolute values of proteinuria between 200 mg and 3.5 g per day

Secondary Outcome Measures

Name	Time	Method
Proteinuria	at 48 week after treatment	The change of proteinuria from baseline to 48 week after treatment
Side effects	For 48 weeks after treatment	Any undesired effects of interventional drugs
estimated Glomerular filtration rate (eGFR)	at 48 week after treatment	The change of eGFR mesured by Modification of Diet in Renal Disease (MDRD) study equation from baseline to 1 year after treatment
Relapse	For 48 weeks after treatment	A relapse is return of proteinuria to approximately 3.5g/day in patients who had previously undergone a complete or partial remission

Trial Locations

Locations (9)

Yeungnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Dong-A University Medical Center; 🇰🇷 Busan, Korea, Republic of

Inje University Haeundae Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Daegu Fatima Hospital; 🇰🇷 Daegu, Korea, Republic of

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of

Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of

Yonsei University Hospital; 🇰🇷 Seoul, Korea, Republic of