Mycophenolate Mofetil Plus Steroid in the Treatment Of Patients With Progressive Idiopathic Membranous Nephropathy (MMF-STOP-IMN)
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ClinicalTrials.gov Identifier: NCT03170323 |
Recruitment Status : Unknown
Verified February 2019 by Guangdong Provincial People's Hospital.
Recruitment status was: Recruiting
First Posted : May 31, 2017
Last Update Posted : March 18, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Idiopathic Membranous Nephropathy | Drug: Mycophenolate Mofetil Drug: Cyclosporins | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 128 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Drug: Mycophenolate mofetil, high dose steroid Drug: Cyclosporin, low dose steroid |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective Randomized, Controlled Trial of Mycophenolate Mofetil Plus Steroid in the Treatment Of Patients With Progressive Idiopathic Membranous Nephropathy |
Actual Study Start Date : | July 1, 2018 |
Estimated Primary Completion Date : | December 31, 2020 |
Estimated Study Completion Date : | December 31, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Mycophenolate mofetil
Drug: Mycophenolate mofetil, high dose steroid Duration: 1 year
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Drug: Mycophenolate Mofetil
steroid 1mg/kg/d and Mycophenolate mofetil 500mg bid |
Active Comparator: Cyclosporin
Drug: Cyclosporin, low dose steroid Duration: 1 year
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Drug: Cyclosporins
steroid 0.15mg/kg/d and Cyclosporin 3-5mg/kg/d |
- Complete Remission [ Time Frame: after treatment for 1 year. ]Urinary protein excretion<0.3 g/d (uPCR<300 mg/g or <30 mg/mmol), confirmed by two values at least 1 week apart, accompanied by a normal serum albumin concentration, and a normal serum creatinine.
- Partial Remission [ Time Frame: after treatment for 1 year. ]Urinary protein excretion <3.5 g/d (uPCR <3500 mg/g or <350 mg/mmol) and a 50% or greater reduction from peak values;confirmed by two values at least 1 week apart, accompanied by an improvement or normalization of the serum albumin concentration and stable serum creatinine.
- estimated Glomerular Filtration Rate [ Time Frame: after treatment for 1 year ]time to a 50% reduction in baseline estimated Glomerular Filtration Rate (according to CKD-EPI)
- serum creatinine [ Time Frame: after treatment for 1 year ]time to doubling of baseline creatinine

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 1.Patients who provided informed consent
- 2.Patients who are diagnosed as membranous nephropathy by renal biopsy,and other secondary factors are excluded
- 3.18 years of age or older, male or female
- 4.24 hours urine protein or spot urine protein/creatinine ratio > 8.0 g/day at least for twice confirmed
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5.The patients that satisfy more than three of following items are included even if proteinuria is less than 8 grams per day:
- estimated glomerular filtration rate(eGFR) < 60 ml/min/1.73m2
- Hypertension (BP above 140/90millimetre of mercury or BP above 120/80millimetre of mercury 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
Exclusion Criteria:
- 1.Severe infective 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 160/100 millimetre of mercury )
- 6.estimated glomerular filtration rate(eGFR)<30 ml/min/1.73m2。
- 7.Abnormal liver function test (more than 3 times above compared with normal value)
- 8.Absolute neutrophil count <1,500/mm3 or leukocyte <2,500/mm3 or platelets <100,000/mm3
- 9.Secondary membranous nephropathy
- 10.Expected life expectancy is less than 1 year
- 11.The researchers evaluated that the patient's compliance was not appropriate for the trial
- 12.Previous or present history of cancer and have risk of recurrence or metastasis

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): NCT03170323
Contact: xinling Liang, M.D.,PH.D | 13808819770 | xinlingliang_ggh@163.com |
China, Guangdong | |
Guangdong General Hospital | Recruiting |
Guangzhou, Guangdong, China | |
Contact: xinling Liang, MD,PhD 86-13808819770 xinlingliang_ggh@163.com |
Principal Investigator: | xinling Liang, M.D.,PH.D | Nephrology Dept,Guangdong General Hospital |
Responsible Party: | Guangdong Provincial People's Hospital |
ClinicalTrials.gov Identifier: | NCT03170323 |
Other Study ID Numbers: |
GGH2016430H |
First Posted: | May 31, 2017 Key Record Dates |
Last Update Posted: | March 18, 2019 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Kidney Diseases Glomerulonephritis, Membranous Urologic Diseases Glomerulonephritis 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 |