Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant

NCT00099736 ↗

Phase 3 Completed 696 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupDouble-blindTreatment

Summary

The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.

Timeline

Start: 2003-05-07
Primary completion: 2005-09-19
Completion: 2005-09-19

Outcome

Mixed primary results

paper FTY720 2.5 mg plus FDC was demonstrated to be non-inferior to MMF plus FDC as the primary efficacy endpoint (30.8% and 30.6%) was comparable. PMID 17198261 ↗

paper The FTY720 5 mg plus RDC treatment regimen was discontinued due to an increased incidence of acute rejection episodes (primary endpoint 43.3%). PMID 17198261 ↗

Publications

Tedesco-Silva H, Pescovitz MD, Cibrik D, Rees MA, Mulgaonkar S, Kahan BD, Gugliuzza KK, Rajagopalan PR, Esmeraldo Rde M, Lord H, Salvadori M, Slade JM; FTY720 Study Group. Randomized controlled trial of FTY720 versus MMF in de novo renal transplantation. Transplantation. 2006 Dec 27;82(12):1689-97. doi: 10.1097/01.tp.0000251718.95622.b3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cyclosporine	Peptide	—	—
Subject	Fingolimod	Small molecule	2.5 mg	—
Subject	Fingolimod	Small molecule	5 mg	—
Subject	MMF 2 g + full-dose Neoral (FDN) + corticosteroids	Unknown	2 g	—

Indications

No indication recorded.