A Study of Safety, Tolerability & Efficacy of Certican in de Novo Heart Transplant (Tx) Patients

Phase 3 Completed 199 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

Summary

The study is designed to evaluate whether Neoral dose optimization together with a therapeutic drug monitoring of Certican will prevent renal dysfunction as observed in the pivotal cardiac trial while maintaining the efficacy. This objective will be assessed by comparing renal function post-transplant between 2 groups of patients.

Timeline

Start: 2004-08-09
Primary completion: 2007-01-08
Completion: 2007-01-08

Outcome

Missed primary endpoint

paper Month 6 (the primary endpoint) was 141.0 ± 53.1 μmol/L in standard-exposure patients versus 130.1 ± 53.7 μmol/L in reduced-exposure patients (P = 0.093). PMID 22295178 ↗

paper No renal function benefits were demonstrated PMID 22295178 ↗

Publications

Results Zuckermann A, Wang SS, Ross H, Frigerio M, Eisen HJ, Bara C, Hoefer D, Cotrufo M, Dong G, Junge G, Keogh AM. Efficacy and Safety of Low-Dose Cyclosporine with Everolimus and Steroids in de novo Heart Transplant Patients: A Multicentre, Randomized Trial. J Transplant. 2011;2011:535983. doi: 10.1155/2011/535983. Epub 2011 Sep 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Everolimus	Small molecule	—	—

Indications

No indication recorded.