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

April 9, 2015 updated by: Sun-Hee Park, Kyungpook National University Hospital

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

62

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 602-715
        • Recruiting
        • Dong-A University Medical Center
        • Contact:
        • Principal Investigator:
          • Won-Suk An, MD
      • Busan, Korea, Republic of
        • Recruiting
        • Inje University Haeundae Paik Hospital
        • Contact:
        • Principal Investigator:
          • Yang-Wook Kim, MD
        • Sub-Investigator:
          • Kyu-Bok Jin, MD
      • Daegu, Korea, Republic of, 700-721
        • Recruiting
        • Kyungpook National University Hospital
        • Contact:
        • Sub-Investigator:
          • Yong-Lim Kim, MD
        • Principal Investigator:
          • Sun-Hee Park, MD
        • Sub-Investigator:
          • Chan-Duck Kim, MD
        • Sub-Investigator:
          • Jang-Hee Cho, MD
        • Sub-Investigator:
          • Ji-Young Choi, MD
      • Daegu, Korea, Republic of, 701-600
        • Recruiting
        • Daegu fatima hospital
        • Contact:
        • Sub-Investigator:
          • Sung-Ho Kim, MD
        • Principal Investigator:
          • Duk-Hyun Lee, MD
      • Daegu, Korea, Republic of, 705-717
        • Recruiting
        • Yeungnam University Medical Center
        • Contact:
        • Principal Investigator:
          • Kyu Hyang Cho, MD
      • Seoul, Korea, Republic of, 110-799
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Sub-Investigator:
          • Suhnggwoon Kim, MD
        • Sub-Investigator:
          • Dong Ki Kim, MD
        • Sub-Investigator:
          • Su Mi Lee, MD
        • Principal Investigator:
          • Yon Su Kim, MD
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Yonsei University Hospital
        • Contact:
        • Sub-Investigator:
          • Shin-Wook Kang, MD
        • Sub-Investigator:
          • Seung Hyeok Han, MD
        • Principal Investigator:
          • Tae-Hyun Yoo, MD
      • Seoul, Korea, Republic of, 156-707
        • Recruiting
        • Boramae Medical Center
        • Contact:
        • Sub-Investigator:
          • Chun Soo Lim, MD
        • Sub-Investigator:
          • Yun Kyu Oh, MD
        • Principal Investigator:
          • Jung Pyo Lee, MD
      • Ulsan, Korea, Republic of, 682-714
        • Recruiting
        • Ulsan University Hospital
        • Contact:
        • Sub-Investigator:
          • Jong-Soo Lee, MD
        • Principal Investigator:
          • Hyun-Chul Chung, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mycophenolate mofetil, low dose steroid
Drug: 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

Other Names:
  • Myconol, MMF
Active Comparator: Cyclosporin, low dose steroid
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

Other Names:
  • Implanta soft capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 48 week after treatment
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
at 48 week after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 48 week after treatment
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
For 48 weeks after treatment
Proteinuria
Time Frame: at 48 week after treatment
The change of proteinuria from baseline to 48 week after treatment
at 48 week after treatment
Side effects
Time Frame: For 48 weeks after treatment
Any undesired effects of interventional drugs
For 48 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Hospital

Collaborators

Hanmi Pharmaceutical Company Limited

Investigators

  • Principal Investigator: Sun-Hee Park, MD, Kyungpook National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

January 19, 2011

First Submitted That Met QC Criteria

January 21, 2011

First Posted (Estimate)

January 24, 2011

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMFPRIMER

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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