Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy (MMFPRIMER)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01282073 |
Recruitment Status : Unknown
Verified April 2015 by Sun-Hee Park, Kyungpook National University Hospital.
Recruitment status was: Recruiting
First Posted : January 24, 2011
Last Update Posted : April 10, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glomerulonephritis, Membranous | Drug: Mycophenolate mofetil, low dose steroid Drug: Cyclosporin, low dose steroid | Phase 3 |
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 |

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 |
- 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
- 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
- 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
- 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
- Proteinuria [ Time Frame: at 48 week after treatment ]The change of proteinuria from baseline to 48 week after treatment
- Side effects [ Time Frame: For 48 weeks after treatment ]Any undesired effects of interventional drugs

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01282073
Contact: Hee-Yeon Jung, MD | +82-10-2536-4106 | 83mayring@hanmail.net |
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 |
Principal Investigator: | Sun-Hee Park, MD | Kyungpook National University Hospital |
Responsible Party: | Sun-Hee Park, Professor, Kyungpook National University Hospital |
ClinicalTrials.gov Identifier: | NCT01282073 |
Other Study ID Numbers: |
MMFPRIMER |
First Posted: | January 24, 2011 Key Record Dates |
Last Update Posted: | April 10, 2015 |
Last Verified: | April 2015 |
Idiopathic membranous nephropathy Mycophenolate mofetil Proteinuria Renal function |
Kidney Diseases Glomerulonephritis Glomerulonephritis, Membranous Urologic Diseases Nephritis Autoimmune Diseases Immune System Diseases Cyclosporine Mycophenolic Acid Cyclosporins 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 |