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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Glomerulonephritis, Membranous	Drug: Mycophenolate mofetil, low dose steroid; Drug: Cyclosporin, low dose steroid	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	62 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Randomized Controlled Multi-center Trial of Mycophenolate Mofetil for the Patient With High Risk Membranous Nephropathy
Study Start Date :	March 2011
Estimated Primary Completion Date :	July 2017
Estimated Study Completion Date :	July 2017

Arms and Interventions

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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 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

Outcome Measures

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Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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:

   • 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

Contacts and Locations

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Contacts

Contact: Hee-Yeon Jung, MD	+82-10-2536-4106	83mayring@hanmail.net

Locations

Korea, Republic of
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
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
Kyungpook National University Hospital	Recruiting
Daegu, Korea, Republic of, 700-721
Contact: Hee-Yeon Jung, MD +82-10-2536-4106 83mayring@hanmail.net
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 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
Yeungnam University Medical Center	Recruiting
Daegu, Korea, Republic of, 705-717
Contact: Kyu Hyang Cho, MD drtoto@hanmail.net
Principal Investigator: Kyu Hyang Cho, 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: Tae-Hyun Yoo, MD YOOSY0316@yuhs.ac
Sub-Investigator: Shin-Wook Kang, MD
Sub-Investigator: Seung Hyeok Han, MD
Principal Investigator: Tae-Hyun Yoo, 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
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Choi JY, Kim DK, Kim YW, Yoo TH, Lee JP, Chung HC, Cho KH, An WS, Lee DH, Jung HY, Cho JH, Kim CD, Kim YL, Park SH. The Effect of Mycophenolate Mofetil versus Cyclosporine as Combination Therapy with Low Dose Corticosteroids in High-risk Patients with Idiopathic Membranous Nephropathy: a Multicenter Randomized Trial. J Korean Med Sci. 2018 Feb 26;33(9):e74. doi: 10.3346/jkms.2018.33.e74.

Responsible Party:	Sun-Hee Park, Professor, Kyungpook National University
ClinicalTrials.gov Identifier:	NCT01282073 History of Changes
Other Study ID Numbers:	MMFPRIMER
First Posted:	January 24, 2011
Last Update Posted:	April 10, 2015
Last Verified:	April 2015

Keywords provided by Sun-Hee Park, Kyungpook National University:

Idiopathic membranous nephropathy; Mycophenolate mofetil; Proteinuria; Renal function

Additional relevant MeSH terms:

Kidney Diseases; Glomerulonephritis; Glomerulonephritis, Membranous; Urologic Diseases; Nephritis; Autoimmune Diseases; Immune System Diseases; Cyclosporins; Cyclosporine; Mycophenolic Acid; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents	Immunologic Factors; Physiological Effects of Drugs; Antifungal Agents; Anti-Infective Agents; Dermatologic Agents; Antirheumatic Agents; Calcineurin Inhibitors; Antibiotics, Antineoplastic; Antineoplastic Agents; Antibiotics, Antitubercular; Antitubercular Agents; Anti-Bacterial Agents