Document Detail


Mycophenolate mofetil as induction and maintenance therapy for lupus nephritis: rationale and protocol for the randomized, controlled Aspreva Lupus Management Study (ALMS).
MedLine Citation:
PMID:  18042591     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The Phase III Aspreva Lupus Management Study (ALMS) will investigate mycophenolate mofetil (MMF) therapy for lupus nephritis (LN). Eligibility criteria include: 12-75 years of age; diagnosis of systemic lupus erythematosus according to revised American College of Rheumatology criteria; and biopsy-demonstrated LN (Class III-V). Randomized patients will receive open-label induction therapy with MMF or cyclophosphamide in combination with corticosteroids for 24 weeks. The primary efficacy endpoint is treatment response [decreased proteinuria and stabilized (within 25% of baseline) or improved serum creatinine level]. Patients achieving response or complete remission (normalization of all parameters) will be rerandomized to double-blind, placebo-controlled maintenance treatment with MMF or azathioprine, both plus corticosteroids. The maintenance phase primary endpoint is time to treatment failure. To detect a 15% rate improvement in the MMF group compared with cyclophosphamide, and to provide 90% power, a total of 358 patients will be required for the induction phase. On the basis of a projected 278 rerandomized patients, the maintenance phase will have 90% power to detect a difference between treatment groups assuming azathioprine and MMF three-year failure rates of 59.5% and 40.7%, respectively. Aspreva Lupus Management Study may provide invaluable comparative data on the efficacy and safety of MMF as LN induction and maintenance therapy.
Authors:
A Sinclair; G Appel; M A Dooley; E Ginzler; D Isenberg; D Jayne; D Wofsy; N Solomons
Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Lupus     Volume:  16     ISSN:  0961-2033     ISO Abbreviation:  Lupus     Publication Date:  2007  
Date Detail:
Created Date:  2007-11-28     Completed Date:  2008-04-01     Revised Date:  2013-05-29    
Medline Journal Info:
Nlm Unique ID:  9204265     Medline TA:  Lupus     Country:  England    
Other Details:
Languages:  eng     Pagination:  972-80     Citation Subset:  IM    
Affiliation:
Aspreva Pharmaceuticals Corp, Victoria, BC, Canada.
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adrenal Cortex Hormones / therapeutic use
Adult
Aged
Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
Child
Drug Therapy, Combination
Female
Humans
Lupus Nephritis / drug therapy*
Male
Middle Aged
Mycophenolic Acid / analogs & derivatives*,  therapeutic use
Remission Induction / methods
Chemical
Reg. No./Substance:
0/Adrenal Cortex Hormones; 0/Anti-Inflammatory Agents, Non-Steroidal; 24280-93-1/Mycophenolic Acid; 9242ECW6R0/mycophenolate mofetil

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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