A Study of Safety, Tolerability & Efficacy of Certican in de Novo Heart Transplant (Tx) Patients
Completed · Phase 3
Conditions studied: Heart Transplantation
In brief
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.
Key facts
- Study ID
- NCT00098007
- Run by
- Novartis Pharmaceuticals
- People needed
- 199
- Starts
- 2004-08-09
- Expected to finish
- 2007-01-08
- Last updated by the study team
- 2017-02-23
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The University of Alabama at Birmingham — Birmingham, Alabama, United States
- Cedar Sinai Medical Center — Los Angeles, California, United States
- Tampa General Hospital — Tampa, Florida, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Newark Beth Israel Medical Center — Newark, New Jersey, United States
- New York Presbyterian Medical Center — New York, New York, United States
- Duke Clinical Research Institute — Durham, North Carolina, United States
- University of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States
- Temple University Hospital — Philadelphia, Pennsylvania, United States
- Texas Heart Institute/St Lukes Hospital — Houston, Texas, United States
- The Baylor College of Medicine/ The Methodist Hospital — Houston, Texas, United States
- St Luke's Medical Center — Milwaukee, Wisconsin, United States
- Study site — Chermside, Queensland, Australia
- Study site — Darlinghurst, Australia
- Study site — Innsbruck, Austria
- Study site — Vienna, Austria
- Study site — Belo Horizonte, Minas Gerais, Brazil
- Study site — São Paulo, Brazil
- Study site — Vancouver, British Columbia, Canada
- Study site — Toronto, Ontario, Canada
- Study site — Hanover, Germany
- Study site — Kiel, Germany
- Study site — Milan, MI, Italy
- Study site — Naples, Italy
- Study site — A Coruña, Spain
Full record on ClinicalTrials.gov
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