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Mycophenolate Mofetil Plus Steroid in the Treatment Of Patients With Progressive Idiopathic Membranous Nephropathy (MMF-STOP-IMN)

Primary Purpose

Idiopathic Membranous Nephropathy

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Mycophenolate Mofetil
Cyclosporins
Sponsored by
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Membranous Nephropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guangdong General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mycophenolate mofetil

Cyclosporin

Arm Description

Drug: Mycophenolate mofetil, high dose steroid Duration: 1 year

Drug: Cyclosporin, low dose steroid Duration: 1 year

Outcomes

Primary Outcome Measures

Complete Remission
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
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

estimated Glomerular Filtration Rate
time to a 50% reduction in baseline estimated Glomerular Filtration Rate (according to CKD-EPI)
serum creatinine
time to doubling of baseline creatinine

Full Information

First Posted
May 26, 2017
Last Updated
March 15, 2019
Sponsor
Guangdong Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03170323
Brief Title
Mycophenolate Mofetil Plus Steroid in the Treatment Of Patients With Progressive Idiopathic Membranous Nephropathy
Acronym
MMF-STOP-IMN
Official Title
A Prospective Randomized, Controlled Trial of Mycophenolate Mofetil Plus Steroid in the Treatment Of Patients With Progressive Idiopathic Membranous Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Provincial People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Membranous Nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Drug: Mycophenolate mofetil, high dose steroid Drug: Cyclosporin, low dose steroid
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mycophenolate mofetil
Arm Type
Experimental
Arm Description
Drug: Mycophenolate mofetil, high dose steroid Duration: 1 year
Arm Title
Cyclosporin
Arm Type
Active Comparator
Arm Description
Drug: Cyclosporin, low dose steroid Duration: 1 year
Intervention Type
Drug
Intervention Name(s)
Mycophenolate Mofetil
Intervention Description
steroid 1mg/kg/d and Mycophenolate mofetil 500mg bid
Intervention Type
Drug
Intervention Name(s)
Cyclosporins
Intervention Description
steroid 0.15mg/kg/d and Cyclosporin 3-5mg/kg/d
Primary Outcome Measure Information:
Title
Complete Remission
Description
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.
Time Frame
after treatment for 1 year.
Title
Partial Remission
Description
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.
Time Frame
after treatment for 1 year.
Secondary Outcome Measure Information:
Title
estimated Glomerular Filtration Rate
Description
time to a 50% reduction in baseline estimated Glomerular Filtration Rate (according to CKD-EPI)
Time Frame
after treatment for 1 year
Title
serum creatinine
Description
time to doubling of baseline creatinine
Time Frame
after treatment for 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xinling Liang, M.D.,PH.D
Phone
13808819770
Email
xinlingliang_ggh@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xinling Liang, M.D.,PH.D
Organizational Affiliation
Nephrology Dept,Guangdong General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xinling Liang, MD,PhD
Phone
86-13808819770
Email
xinlingliang_ggh@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34778952
Citation
von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.
Results Reference
derived

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Mycophenolate Mofetil Plus Steroid in the Treatment Of Patients With Progressive Idiopathic Membranous Nephropathy

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