A Study of Safety, Tolerability & Efficacy of Certican in de Novo Heart Transplant (Tx) Patients
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|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|
|Actual Primary Completion Date :||January 8, 2007|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00098007
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