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

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ClinicalTrials.gov Identifier: NCT01854814
Recruitment Status : Recruiting
First Posted : May 16, 2013
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Fan Fan Hou, Nanfang Hospital of Southern Medical University

Tracking Information
First Submitted Date  ICMJE May 9, 2013
First Posted Date  ICMJE May 16, 2013
Last Update Posted Date December 15, 2017
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2016)
  • To evaluate the effects of mycophenolate mofetil on a composite renal outcomes in subjects with advanced IgA nephropathy [ Time Frame: 3 years ]
    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 [ Time Frame: 3 years ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2013)
To evaluate the effects of mycophenolate mofetil on a composite renal outcomes in subjects with advanced IgA nephropathy [ Time Frame: 3 years ]
Time to the first occurrence of a component of the composite renal endpoint: Doubling of serum creatinine or the onset of ESRD (needing chronic dialysis or renal transplantation or renal death)
Change History Complete list of historical versions of study NCT01854814 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2016)
  • To evaluate the effects of mycophenolate mofetil on the changes of proteinuria in subjects with advanced IgA nephropathy [ Time Frame: 3 years ]
    Changes of urinary protein excretion rate
  • To evaluate the effects of mycophenolate mofetil rapid progression of CKD in subjects with advanced IgA nephropathy [ Time Frame: 3 years ]
    Time to 30% reduction in estimated glomerular filtration rate (eGFR); eGFR reduction greater than 5 ml/min/1.73m^2/year
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2013)
  • To evaluate the effects of mycophenolate mofetil on the changes of proteinuria in subjects with advanced IgA nephropathy [ Time Frame: 3 years ]
    Changes of urinary protein excretion rate
  • To evaluate the effects of mycophenolate mofetil on composite changes of renal function in subjects with advanced IgA nephropathy [ Time Frame: 3 years ]
    Time to 30% reduction in eGFR; Changing from chronic kidney disease stage 3 to stage 4 using the CKD-EPI formula; eGFR reduction greater than 5 ml/min/1.73m^2/year;
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Mycophenolate Mofetil (MMF) on Renal Outcomes in Advanced Immunoglobulin A (IgA) Nephropathy Patients
Official Title  ICMJE The Effects of Mycophenolate Mofetil on Renal Outcomes in Patients With Advanced IgA Nephropathy: a Randomized Open-label Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE IgA Nephropathy
Intervention  ICMJE
  • Drug: Mycophenolate mofetil
    Mycophenolate mofetil 1.5g/day plus maximum tolerated labeled dose losartan
  • Drug: Losartan
    Maximum tolerated labeled dose of Losartan
Study Arms  ICMJE
  • Experimental: mycophenolate mofetil
    mycophenolate mofetil 1.5g/day and maximum tolerated labeled dose of losartan
    Intervention: Drug: Mycophenolate mofetil
  • Active Comparator: losartan
    maximus tolerated labeled dose of losartan
    Intervention: Drug: Losartan
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2013)
232
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fan Fan Hou, M.D.,PhD 0086-20-61641591 ffhouguangzhou@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01854814
Other Study ID Numbers  ICMJE MAIN
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fan Fan Hou, Nanfang Hospital of Southern Medical University
Study Sponsor  ICMJE Fan Fan Hou
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fan Fan Hou, M.D., PhD Division of nephrology, Nanfang Hospital Southern Medical University
PRS Account Nanfang Hospital of Southern Medical University
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP