drugset / Trial / NCT00396721
Sirolimus Therapy for Poor Prognosis Immunoglobulin A Nephropathy
Phase 2
Completed
23 enrolled
Josep m Cruzado
Wyeth is now a wholly owned subsidiary of Pfizer · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to test in a pilot trial the efficacy and tolerance of sirolimus oral (at low doses) in patient to treat poor-prognosis IgA Nephropathy.
Timeline
- Start
- 2006-01
- Primary completion
- 2009-10
- Completion
- 2010-02
Publications
- Background Donadio JV, Grande JP. IgA nephropathy. N Engl J Med. 2002 Sep 5;347(10):738-48. doi: 10.1056/NEJMra020109. No abstract available.
- Background Donadio JV Jr, Bergstralh EJ, Offord KP, Spencer DC, Holley KE. A controlled trial of fish oil in IgA nephropathy. Mayo Nephrology Collaborative Group. N Engl J Med. 1994 Nov 3;331(18):1194-9. doi: 10.1056/NEJM199411033311804.
- Background Wu H, Clarkson AR, Knight JF. Restricted gammadelta T-cell receptor repertoire in IgA nephropathy renal biopsies. Kidney Int. 2001 Oct;60(4):1324-31. doi: 10.1046/j.1523-1755.2001.00937.x.
- Background Bonegio RG, Fuhro R, Wang Z, Valeri CR, Andry C, Salant DJ, Lieberthal W. Rapamycin ameliorates proteinuria-associated tubulointerstitial inflammation and fibrosis in experimental membranous nephropathy. J Am Soc Nephrol. 2005 Jul;16(7):2063-72. doi: 10.1681/ASN.2004030180. Epub 2005 May 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sirolimus | Small molecule | 1 mg | Oral |
| Comparator | Atorvastatin | Small molecule | 10 mg | — |
| Comparator | Enalapril | Other / unclassified | 5 mg | — |