Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy - Full Text View

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:

MedlinePlus related topics: Kidney Diseases

Drug Information available for: Mycophenolic acid Mycophenolate sodium Cyclosporine Mycophenolate mofetil hydrochloride Mycophenolate mofetil

Genetic and Rare Diseases Information Center resources: Glomerulonephritis Membranous Nephropathy

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:	July 2017
Estimated Primary Completion Date:	July 2017 (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 and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282073

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


Responsible Party:	Sun-Hee Park, Professor, Kyungpook National University
ClinicalTrials.gov Identifier:	NCT01282073 History of Changes
Other Study ID Numbers:	MMFPRIMER
Study First Received:	January 19, 2011
Last Updated:	April 9, 2015
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:


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

ClinicalTrials.gov processed this record on September 30, 2016

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