A randomized controlled trial of mycophenolate mofetil in patients with IgA nephropathy [ISRCTN62574616].
BACKGROUND
IgAN is the most common type of glomerulonephritis in the world. Between 15 and 40 percent of adults and children diagnosed with IgAN eventually progress to ESRD. Despite the need for effective treatment strategies, very few RCTs for IgAN have been performed. The most effective therapies for IgAN appear to be corticosteroids, ACEi, and FOS that contain a high concentration of omega 3 fatty acids. While ACEi and FOS are generally well tolerated with minimal side effects, the use of high dose steroids over a long course of therapy is often associated with significant morbidity.


OBJECTIVE
The objective of the study is to test the hypothesis that treatment with the immunosuppressive agent, MMF, will lead to significant and sustained improvement in urinary protein excretion in patients with IgAN 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.


METHODS
After a three month treatment period with the ACEi, lisinopril and the FOS, Omacor, 100 (2 x 50) patients with IgAN and a urinary P/C ratio > or = 0.6 (males) and > or = 0.8 (females) and an estGFR > or = 40 ml/min/1.73 m2 will be randomized to treatment with either MMF or placebo for one year. All patients will be followed off study drug for a second year, but will continue treatment with lisinopril and Omacor for the two year duration of the study. The primary outcome measure of change in urine P/C ratio will be assessed at the end of years one and two.
Hogg
Ronald J
RJ
Department of Pediatrics, Medical City Dallas Hospital, Dallas, TX, USA. spnsg@lonestarhealth.com
Wyatt
Robert J
RJ
D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use; D004281:Docosahexaenoic Acids / Q000627:therapeutic use; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D015118:Eicosapentaenoic Acid / Q000627:therapeutic use; D005260:Female; D005919:Glomerular Filtration Rate; D005922:Glomerulonephritis, IGA / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D017706:Lisinopril / Q000627:therapeutic use; D008297:Male; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D011507:Proteinuria / Q000188:drug therapy / Q000209:etiology; D012107:Research Design; D016896:Treatment Outcome
D000806:Angiotensin-Converting Enzyme Inhibitors; D004338:Drug Combinations; D007166:Immunosuppressive Agents; D004281:Docosahexaenoic Acids; D015118:Eicosapentaenoic Acid; C405603:Omacor; D017706:Lisinopril; D009173:Mycophenolic Acid