Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant
Completed · Phase 3
Conditions studied: Heart Transplantation, Liver Transplantation, Kidney Transplantation
In brief
The purpose of this study was to offer patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until commercial availability of the drug and to record long term efficacy and safety data.
Key facts
- Study ID
- NCT02118896
- Run by
- Astellas Pharma Europe Ltd.
- People needed
- 850
- Starts
- 2003-02-24
- Expected to finish
- 2009-10-07
- Last updated by the study team
- 2024-11-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients who had already participated in the previous phase II pharmacokinetic or phase III studies with FK506E (MR4).
- Patients capable of understanding the purpose and risks of the study, who had been fully informed and given written informed consent to participate in the study.
You may not qualify if…
- Pregnant women or nursing mothers.
- Women unwilling or unable to use adequate contraception during the study.
Where it is running
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
- Princess Alexandra Hospital — Brisbane, Queensland, Australia
- Austin Hospital — Heidelberg, Victoria, Australia
- Royal Melbourne Hospital — Melbourne, Victoria, Australia
- Landeskrankenhaus Innsbruck — Innsbruck, Austria
- AKN Wien — Vienna, Austria
- Hospital Erasme — Brussels, Belgium
- Cliniques Universitaires St. Luc — Brussels, Belgium
- Departement Heelkunde — Ghent, Belgium
- Universitair Ziekenhuis Gasthuisberg — Leuven, Belgium
- Domaine Universitaire du Sart Tillman — Liège, Belgium
- Hospital da Clínicas da UNICAMP — Campinas, Brazil
- Hospital São Francisco — Porto Alegre, Brazil
- Irmandade da Santa Casa de Misericordia de Porto Alegre — Porto Alegre, Brazil
- Hospital Geral de Bonsucesso — Rio de Janeiro, Brazil
- University of Alberta — Edmonton, Alberta, Canada
- London Health Sciences Centre — London, Ontario, Canada
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada
- Institut de Cardiologie de Montréal — Montreal, Quebec, Canada
- Centre Hospitalier de l'Universite de Montreal (CHUM) — Montreal, Quebec, Canada
- Royal Victoria Hospital — Montreal, Quebec, Canada
- Vancouver Hospital & Health Sciences Centre — Vancouver, Canada
- IKEM — Prague, Czechia
- Skejby University Hospital — Århus N, Denmark
- University Hospital — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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