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NCT Number: NCT01282073

Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy

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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Key information

Conditions

Glomerulonephritis, Membranous Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dong-A University Medical Center, Busan, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 < 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

  • 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

Treatment and study plan

Mycophenolate mofetil, low dose steroid

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

Other names: Myconol, MMF

Cyclosporin, low dose steroid

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

Other names: Implanta soft capsule

Primary outcomes

  1. Percentage of Complete Remission

    Time frame: 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

  2. Percentage of Partial Remission

    Time frame: 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 outcomes

  1. Estimated Glomerular Filtration Rate (eGFR)

    Time frame: 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

  2. Relapse

    Time frame: 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

  3. Proteinuria

    Time frame: at 48 week after treatment

    The change of proteinuria from baseline to 48 week after treatment

  4. Side Effects

    Time frame: For 48 weeks after treatment

    Any undesired effects of interventional drugs

Sponsors and collaborators

Lead sponsor

Kyungpook National University Hospital

Other

Collaborators

  • Hanmi Pharmaceutical Company Limited

Registry information

Official study title

A Randomized Controlled Multi-center Trial of Mycophenolate Mofetil for the Patient With High Risk Membranous Nephropathy

Acronym: MMFPRIMER

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jan 24, 2011
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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