NCT00318474

Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy

A Randomized Controlled Trial of Mycophenolate Mofetil in Patients With IgA Nephropathy

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: St. Joseph's Hospital and Medical Center, Phoenix · Academic / Other
• Sex: All
• Age: 7 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

IgA nephropathy (IgAN) is the most common type of glomerulonephritis worldwide. 15-40% of individuals diagnosed with IgAN, including children, will eventually progress to chronic renal insufficiency (CRI) and end stage renal disease (ESRD). The study is to evaluate the safety and benefits of MMF in patients with IgAN who have been pre-treated (and continue to be treated) with angiotensin converting enzyme inhibitors (ACEi) and fish oil supplements (FOS).

Detailed description

A multi-center, randomized, controlled clinical trial to test the hypothesis that treatment with mycophenolate mofetil (MMF) will lead to significant and sustained improvement in proteinuria in patients with IgA Nephropathy who have been pre-treated (and continue to be treated) with ACEi and FOS compared to a placebo control group of patients receiving comparable doses of ACEi and FOS without MMF. Data for this outcome will be examined every six months and at the end of 2 years of study. Comparisons will be made between the two treatment groups for change from entry level in urine protein to creatinine (UPr/Cr) ratio, 24-hour urine protein excretion rate and estimated glomerular filtration rate (GFR).

Conditions

• IgA Nephropathy

Interventions

Type	Name	Description
DRUG	Mycophenolate Mofetil (MMF)	Oral administration of MMF; dose based on body size (between 25mg/kg/day and 36ng/kg/day); maximum dose 1gm BID.
DRUG	MMF Placebo	Placebo only, oral administration
DRUG	ACEi	Administer same as pre-treatment regimen.
DRUG	FOS	Administer same as pre-treatment regimen

Timeline

• Start date: 2002-01-01
• Primary completion: 2008-03-01
• Completion: 2010-03-01
• First posted: 2006-04-26
• Last updated: 2016-03-07
• Results posted: 2014-10-01

Locations

1 site across 1 country: United States