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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
Sponsor:
Information provided by (Responsible Party):
Guangdong Provincial People's Hospital

Study Description
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Brief Summary:
Idiopathic membranous nephropathy (IMN) remains a common cause of the nephrotic syndrome in adults. There are few randomized clinical trials regarding the therapeutic effect of mycophenolate mofetil in patients with Idiopathic membranous nephropathy. This study aims to evaluate whether treatment with mycophenolate mofetil is non-inferior to cyclosporins in inducing long-term remission (complete or partial) of proteinuria in patients with idiopathic membranous nephropathy.

Condition or disease Intervention/treatment Phase
Idiopathic Membranous Nephropathy Drug: Mycophenolate Mofetil Drug: Cyclosporins Phase 4

Detailed Description:
Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults. In recent year, IMN remains one of the most common glomerular diseases. Long-term remission and stable renal function can prevent idiopathic membranous nephropathy from progressing to end-stage renal disease. Cyclosporine and cyclophosphamide are recommended to be first-line treatment regimen. Corticosteroid is the basic combined drug in the treatment of idiopathic membranous nephropathy. Mycophenolate mofetil is a recently developed immunosuppressive agent with fewer renal toxicity than cyclosporin.Besides, high dose prednisone may be effective for patients in Asia according to literatures from Asia. In our study, patients with idiopathic membranous nephropathy would be treated with mycophenolate mofetil and high dose prednisone,whose outcome will be compared with cyclosporin and low dose prednisone. We aims to evaluate whether treatment with mycophenolate mofetil is non-inferior to cyclosporins in inducing long-term remission of proteinuria in patients with idiopathic membranous nephropathy.
Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Mycophenolate mofetil
Drug: Mycophenolate mofetil, high dose steroid Duration: 1 year
 Drug: Mycophenolate Mofetil
steroid 1mg/kg/d and Mycophenolate mofetil 500mg bid
Active Comparator: Cyclosporin
Drug: Cyclosporin, low dose steroid Duration: 1 year
 Drug: Cyclosporins
steroid 0.15mg/kg/d and Cyclosporin 3-5mg/kg/d


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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)

  2. serum creatinine [ Time Frame: after treatment for 1 year ]
    time to doubling of baseline creatinine


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  • 5.The patients that satisfy more than three of following items are included even if proteinuria is less than 8 grams per day:

    1. estimated glomerular filtration rate(eGFR) < 60 ml/min/1.73m2
    2. Hypertension (BP above 140/90millimetre of mercury or BP above 120/80millimetre of mercury in patients taking anti-hypertensive agents)
    3. 24 hours urine protein or spot urine protein/creatinine ratio > 5.0 g/day
    4. 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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: xinling Liang, M.D.,PH.D 13808819770 xinlingliang_ggh@163.com

Locations
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China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China
Contact: xinling Liang, MD,PhD    86-13808819770    xinlingliang_ggh@163.com   
Sponsors and Collaborators
Guangdong Provincial People's Hospital
Investigators
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Principal Investigator: xinling Liang, M.D.,PH.D Nephrology Dept,Guangdong General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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