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NCT02118896 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Kidney Transplantation and Liver Transplantation, sponsored by Astellas Pharma Europe.
- Completed
- Registry status
- Phase 3
- Development phase
- 850
- Enrollment target
- 20
- Study locations
NCT02118896 is a Phase 3 study of Kidney Transplantation and Liver Transplantation that has completed, run by Astellas Pharma Europe. The registered enrollment target is 850 participants, above the 242-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (251% higher). The trial reports 20 study locations across 8 states.
The verdict
NCT02118896, a Phase 3 study of Kidney Transplantation and Liver Transplantation, has completed, sponsored by Astellas Pharma Europe.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 850 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG FK506E
Study Locations (20)
Other
- Landeskrankenhaus Innsbruck - Innsbruck
- AKN Wien - Vienna
- Hospital Erasme - Brussels
- Cliniques Universitaires St. Luc - Brussels
- Departement Heelkunde - Ghent
- Universitair Ziekenhuis Gasthuisberg - Leuven
- Domaine Universitaire du Sart Tillman - Liège
- Hospital da Clínicas da UNICAMP - Campinas
- Hospital São Francisco - Porto Alegre
- Irmandade da Santa Casa de Misericordia de Porto Alegre - Porto Alegre
- Hospital Geral de Bonsucesso - Rio de Janeiro
Victoria
- Austin Hospital - Heidelberg
- Royal Melbourne Hospital - Melbourne
Ontario
- London Health Sciences Centre - London
- University of Ottawa Heart Institute - Ottawa
Ohio
- University Hospital - Cincinnati
New South Wales
- Royal Prince Alfred Hospital - Camperdown
Queensland
- Princess Alexandra Hospital - Brisbane
Alberta
- University of Alberta - Edmonton
Quebec
- Institut de Cardiologie de Montréal - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 850 participants |
| Start Date | 2003-02-24 |
| Est. Completion | 2009-10-07 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02118896
The ClinicalTrials.gov registry entry for NCT02118896 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 850 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 242-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (251% higher). The listed sponsor is Astellas Pharma Europe, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Kidney Transplantation appearing as the primary indexed condition, and to 1 intervention - of which FK506E is the first listed.
NCT02118896 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, Victoria, Ontario.
Frequently Asked Questions
What is clinical trial NCT02118896 about?
NCT02118896 is a clinical study titled "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". 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.
What is the current status of trial NCT02118896?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 850 participants. The study started on 2003-02-24. Estimated completion is 2009-10-07.
What conditions does trial NCT02118896 study?
This clinical trial studies the following conditions: Kidney Transplantation, Liver Transplantation, Heart Transplantation.
What interventions are being tested in trial NCT02118896?
The interventions under investigation include: FK506E (DRUG).
Who is sponsoring clinical trial NCT02118896?
This trial is sponsored by Astellas Pharma Europe, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02118896 being conducted?
This trial has 20 study locations across Ohio, New South Wales, Queensland, Victoria, Alberta. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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