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NCT Number: NCT01854814

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

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.

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Key information

Conditions

IgA Nephropathy Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanfang Hospital Southern Medical University, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mycophenolate mofetil

Drug

Mycophenolate mofetil 1.5g/day plus maximum tolerated labeled dose losartan

Losartan

Drug

Maximum tolerated labeled dose of Losartan

Primary outcomes

  1. 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]

  2. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Fan Fan Hou

Other

Registry information

Official study title

The Effects of Mycophenolate Mofetil on Renal Outcomes in Patients With Advanced IgA Nephropathy: a Randomized Open-label Study

Acronym: MAIN

Important dates

Study start
2013
Primary completion
2022
Study completion
2022
First posted
May 16, 2013
Registry last updated
Jul 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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