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The Effects of Mycophenolate Mofetil (MMF) on Renal Outcomes in Advanced Immunoglobulin A (IgA) Nephropathy Patients (MAIN)

Primary Purpose

IgA Nephropathy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mycophenolate mofetil
Losartan
Sponsored by
Fan Fan Hou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Nephropathy

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Biopsy-proven primary IgA nephropathy with urinary proteinuria excretion over 1g/24 hour,subjects must meet 2 of the following criteria:

    1. global glomerular sclerosis plus focal segmental glomerular sclerosis ratio ≥50%
    2. eGFR 30 to 60 ml/min
    3. Hypertension (blood pressure over 140/90 mmHg or taking antihypertensive drugs)

Exclusion Criteria:

  1. Secondary IgA nephropathy
  2. Familial IgA nephropathy
  3. Concomitant disease: cancer, infection, diabetes mellitus, connective tissue disease, abnormal liver function
  4. Pregnancy or breasting
  5. Inability to comply with study and follow-up procedures

Sites / Locations

  • Nanfang Hospital Southern Medical University
  • The Fourth People's Hospital Shenzhen
  • The Institute of Nephrology, Guangdong Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mycophenolate mofetil

losartan

Arm Description

mycophenolate mofetil 1.5g/day and maximum tolerated labeled dose of losartan

maximus tolerated labeled dose of losartan

Outcomes

Primary Outcome Measures

To evaluate the effects of mycophenolate mofetil on a composite renal outcomes in subjects with advanced IgA nephropathy
Time to the first occurrence of a component of the composite renal endpoint: Doubling of serum creatinine or the onset of end stage renal disease (ESRD) [needing chronic dialysis or renal transplantation or renal death]
To evaluate the effects of mycophenolate mofetil on progression of CKD in subjects with advanced IgA nephropathy
A decrease in eGFR of 30% or more and to a level of less than 60 ml/min at the exit visit if the baseline eGFR was 60 ml/min or more. Or a decrease in eGFR of 50% or more at the exit visit if the baseline eGFR was less than 60 ml/min.

Secondary Outcome Measures

To evaluate the effects of mycophenolate mofetil on the changes of proteinuria in subjects with advanced IgA nephropathy
Changes of urinary protein excretion rate
To evaluate the effects of mycophenolate mofetil rapid progression of CKD in subjects with advanced IgA nephropathy
Time to 30% reduction in estimated glomerular filtration rate (eGFR); eGFR reduction greater than 5 ml/min/1.73m^2/year

Full Information

First Posted
May 9, 2013
Last Updated
July 7, 2022
Sponsor
Fan Fan Hou
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1. Study Identification

Unique Protocol Identification Number
NCT01854814
Brief Title
The Effects of Mycophenolate Mofetil (MMF) on Renal Outcomes in Advanced Immunoglobulin A (IgA) Nephropathy Patients
Acronym
MAIN
Official Title
The Effects of Mycophenolate Mofetil on Renal Outcomes in Patients With Advanced IgA Nephropathy: a Randomized Open-label Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 2013 (Actual)
Primary Completion Date
February 2022 (Actual)
Study Completion Date
May 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fan Fan Hou

4. Oversight

5. Study Description

Brief Summary
The study is to evaluate the effect of Mycophenolate Mofetil compared with losartan alone on time to doubling of serum creatinine or the onset of end stage renal disease in patients with advanced IgA nephropathy who are treated with the maximal tolerated daily dose of losartan.The study will also assess the effects of MMF compared with losartan alone on the changes of urine albumin excretion and the changes in estimated glomerular filtration rate.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
238 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mycophenolate mofetil
Arm Type
Experimental
Arm Description
mycophenolate mofetil 1.5g/day and maximum tolerated labeled dose of losartan
Arm Title
losartan
Arm Type
Active Comparator
Arm Description
maximus tolerated labeled dose of losartan
Intervention Type
Drug
Intervention Name(s)
Mycophenolate mofetil
Intervention Description
Mycophenolate mofetil 1.5g/day plus maximum tolerated labeled dose losartan
Intervention Type
Drug
Intervention Name(s)
Losartan
Intervention Description
Maximum tolerated labeled dose of Losartan
Primary Outcome Measure Information:
Title
To evaluate the effects of mycophenolate mofetil on a composite renal outcomes in subjects with advanced IgA nephropathy
Description
Time to the first occurrence of a component of the composite renal endpoint: Doubling of serum creatinine or the onset of end stage renal disease (ESRD) [needing chronic dialysis or renal transplantation or renal death]
Time Frame
3 years
Title
To evaluate the effects of mycophenolate mofetil on progression of CKD in subjects with advanced IgA nephropathy
Description
A decrease in eGFR of 30% or more and to a level of less than 60 ml/min at the exit visit if the baseline eGFR was 60 ml/min or more. Or a decrease in eGFR of 50% or more at the exit visit if the baseline eGFR was less than 60 ml/min.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
To evaluate the effects of mycophenolate mofetil on the changes of proteinuria in subjects with advanced IgA nephropathy
Description
Changes of urinary protein excretion rate
Time Frame
3 years
Title
To evaluate the effects of mycophenolate mofetil rapid progression of CKD in subjects with advanced IgA nephropathy
Description
Time to 30% reduction in estimated glomerular filtration rate (eGFR); eGFR reduction greater than 5 ml/min/1.73m^2/year
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Biopsy-proven primary IgA nephropathy with urinary proteinuria excretion over 1g/24 hour,subjects must meet 2 of the following criteria: global glomerular sclerosis plus focal segmental glomerular sclerosis ratio ≥50% eGFR 30 to 60 ml/min Hypertension (blood pressure over 140/90 mmHg or taking antihypertensive drugs) Exclusion Criteria: Secondary IgA nephropathy Familial IgA nephropathy Concomitant disease: cancer, infection, diabetes mellitus, connective tissue disease, abnormal liver function Pregnancy or breasting Inability to comply with study and follow-up procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fan Fan Hou, M.D., PhD
Organizational Affiliation
Division of nephrology, Nanfang Hospital Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanfang Hospital Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
The Fourth People's Hospital Shenzhen
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Facility Name
The Institute of Nephrology, Guangdong Medical College
City
Zhanjiang
State/Province
Guangdong
ZIP/Postal Code
524001
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
20032964
Citation
Tang SC, Tang AW, Wong SS, Leung JC, Ho YW, Lai KN. Long-term study of mycophenolate mofetil treatment in IgA nephropathy. Kidney Int. 2010 Mar;77(6):543-9. doi: 10.1038/ki.2009.499. Epub 2009 Dec 23.
Results Reference
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PubMed Identifier
16030050
Citation
Frisch G, Lin J, Rosenstock J, Markowitz G, D'Agati V, Radhakrishnan J, Preddie D, Crew J, Valeri A, Appel G. Mycophenolate mofetil (MMF) vs placebo in patients with moderately advanced IgA nephropathy: a double-blind randomized controlled trial. Nephrol Dial Transplant. 2005 Oct;20(10):2139-45. doi: 10.1093/ndt/gfh974. Epub 2005 Jul 19.
Results Reference
background

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The Effects of Mycophenolate Mofetil (MMF) on Renal Outcomes in Advanced Immunoglobulin A (IgA) Nephropathy Patients

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