A Study of Safety, Tolerability & Efficacy of Certican in de Novo Heart Transplant (Tx) Patients
|ClinicalTrials.gov Identifier: NCT00098007|
Recruitment Status : Completed
First Posted : December 2, 2004
Last Update Posted : February 23, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Transplantation||Drug: Everolimus (Certican)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||199 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Six-month, Multicenter, Randomized, Open-label Study of the Safety, Tolerability and Efficacy of Two Neoral Doses in Addition to Certican and Steroids in de Novo Heart Transplant Recipients|
|Study Start Date :||August 9, 2004|
|Primary Completion Date :||January 8, 2007|
|Study Completion Date :||January 8, 2007|
- Renal function at 6 months post-transplant.
- Incidence of biopsy proven acute rejection ≥3A at 6 months.
- Incidence of acute rejection associated with hemodynamic compromise at 6 months.
- Incidence of graft loss at 6 months.
- Incidence of death at 6 months.
- Incidence of premature patient withdrawal and study treatment discontinuation at 6 months.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00098007
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