Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Glomerulonephritis, Membranous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mycophenolate mofetil, low dose steroid

Group Type EXPERIMENTAL

Mycophenolate mofetil, low dose steroid

Intervention Type DRUG

Mycophenolate Mofetil: Myconol capsule 250mg, Myconol 500 mg bid per day (less than 50kg), 750 \~ 1000 mg bid per day (more than 50kg)

Steroid: Methylprednisone 4mg tablet or Prednisolone 5mg tablet or Deflazacort 6mg tablet. Prednisolone dose: 0.15mg/kg up to a maximum dose of 15mg/day

Duration: 48 weeks

Cyclosporin, low dose steroid

Group Type ACTIVE_COMPARATOR

Cyclosporin, low dose steroid

Intervention Type DRUG

Cyclosporin: Implanta soft cap (cyclosporin microemulsion) 25mg/100mg, starting dose of 4mg/kg per day and titrate according to investigator's decision based on cyclosporin trough level (100±50 ng/ml)

Steroid: same dosage with active comparator goup

Duration: 48 weeks

Interventions

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Mycophenolate mofetil, low dose steroid

Mycophenolate Mofetil: Myconol capsule 250mg, Myconol 500 mg bid per day (less than 50kg), 750 \~ 1000 mg bid per day (more than 50kg)

Steroid: Methylprednisone 4mg tablet or Prednisolone 5mg tablet or Deflazacort 6mg tablet. Prednisolone dose: 0.15mg/kg up to a maximum dose of 15mg/day

Duration: 48 weeks

Intervention Type DRUG

Cyclosporin, low dose steroid

Cyclosporin: Implanta soft cap (cyclosporin microemulsion) 25mg/100mg, starting dose of 4mg/kg per day and titrate according to investigator's decision based on cyclosporin trough level (100±50 ng/ml)

Steroid: same dosage with active comparator goup

Duration: 48 weeks

Intervention Type DRUG

Other Intervention Names

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Myconol, MMF Implanta soft capsule

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No