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

This study is currently recruiting participants.
Verified January 2012 by Kyungpook National University
Sponsor:
Collaborator:
Hanmi Pharmaceutical Company Limited
Information provided by (Responsible Party):
Sun-Hee Park, Kyungpook National University
ClinicalTrials.gov Identifier:
NCT01282073
First received: January 19, 2011
Last updated: January 10, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Glomerulonephritis, Membranous
 Drug: Mycophenolate mofetil, low dose steroid
Drug: Cyclosporin, low dose steroid
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Multi-center Trial of Mycophenolate Mofetil for the Patient With High Risk Membranous Nephropathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kyungpook National University:

Primary Outcome Measures:
  • Percentage of complete remission [ Time Frame: at 48 week after treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: at 48 week after treatment ] [ Designated as safety issue: No ]
    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:
  • estimated Glomerular filtration rate (eGFR) [ Time Frame: at 48 week after treatment ] [ Designated as safety issue: No ]
    The change of eGFR mesured by Modification of Diet in Renal Disease (MDRD) study equation from baseline to 1 year after treatment

  • Relapse [ Time Frame: For 48 weeks after treatment ] [ Designated as safety issue: No ]
    A relapse is return of proteinuria to approximately 3.5g/day in patients who had previously undergone a complete or partial remission

  • Proteinuria [ Time Frame: at 48 week after treatment ] [ Designated as safety issue: No ]
    The change of proteinuria from baseline to 48 week after treatment

  • Side effects [ Time Frame: For 48 weeks after treatment ] [ Designated as safety issue: Yes ]
    Any undesired effects of interventional drugs


Estimated Enrollment: 62
Study Start Date: March 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Implanta soft capsule

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    • Serum creatinine (mg/dl) above normal
    • Hypertension
    • Nephrotic syndrome
    • Serum albumin (g/dL) < 1.5
    • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282073

Contacts
Contact: Se-Hee Yoon, MD +82-11-9403-9623 sehei@hanmail.net

Locations
Korea, Republic of
Inje University Haeundae Paik Hospital Recruiting
Busan, Korea, Republic of
Contact: Kyu-Bok Jin, MD         mdjin922@gmail.com    
Principal Investigator: Yang-Wook Kim, MD            
Sub-Investigator: Kyu-Bok Jin, MD            
Dong-A University Medical Center Recruiting
Busan, Korea, Republic of, 602-715
Contact: Won-Suk An, MD         anws@dau.ac.kr    
Principal Investigator: Won-Suk An, MD            
Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of, 700-721
Contact: Se-Hee Yoon, MD     +82-11-9403-9623     sehei@hanmail.net    
Sub-Investigator: Yong-Lim Kim, MD            
Principal Investigator: Sun-Hee Park, MD            
Sub-Investigator: Chan-Duck Kim, MD            
Sub-Investigator: Ji-Young Choi, MD            
Sub-Investigator: Se-Hee Yoon, MD            
Yeungnam University Medical Center Recruiting
Daegu, Korea, Republic of, 705-717
Contact: Jong-Won Park, MD         jwpark@medical.yu.ac.kr    
Principal Investigator: Jong-Won Park, MD            
Daegu Fatima Hospital Recruiting
Daegu, Korea, Republic of, 701-600
Contact: Duk-Hyun Lee, MD     +82-53-940-7221     dhlee@fatima.or.kr    
Sub-Investigator: Sung-Ho Kim, MD            
Principal Investigator: Duk-Hyun Lee, MD            
Boramae Medical Center Recruiting
Seoul, Korea, Republic of, 156-707
Contact: Jung Pyo Lee, MD         kjwa1@medimail.co.kr    
Sub-Investigator: Chun Soo Lim, MD            
Sub-Investigator: Yun Kyu Oh, MD            
Principal Investigator: Jung Pyo Lee, MD            
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-799
Contact: Yon Su Kim, MD         yonsukim@snu.ac.kr    
Sub-Investigator: Suhnggwoon Kim, MD            
Sub-Investigator: Dong Ki Kim, MD            
Sub-Investigator: Su Mi Lee, MD            
Principal Investigator: Yon Su Kim, MD            
Yonsei University Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Seung Hyeok Han, MD         HANSH@yuhs.ac    
Principal Investigator: Shin-Wook Kang, M.D.            
Sub-Investigator: Seung Hyeok Han            
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of, 682-714
Contact: Hyun-Chul Chung, MD         hcjungmd@uuh.ulsan.kr    
Sub-Investigator: Jong-Soo Lee, MD            
Principal Investigator: Hyun-Chul Chung, MD            
Sponsors and Collaborators
Kyungpook National University
Hanmi Pharmaceutical Company Limited
Investigators
Principal Investigator: Sun-Hee Park, MD Kyungpook National University
  More Information

No publications provided

Responsible Party: Sun-Hee Park, Associate professor, Kyungpook National University
ClinicalTrials.gov Identifier: NCT01282073     History of Changes
Other Study ID Numbers: MMFPRIMER
Study First Received: January 19, 2011
Last Updated: January 10, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Kyungpook National University:
Idiopathic membranous nephropathy
Mycophenolate mofetil
Proteinuria
Renal function

Additional relevant MeSH terms:
Glomerulonephritis
Glomerulonephritis, Membranous
Kidney Diseases
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Cyclosporins
Cyclosporine
Mycophenolic Acid
Mycophenolate mofetil
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013