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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: Completed Phase 3 study of Kidney Transplantation and Liver Transplantation, sponsored by Astellas Pharma Europe.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Participant survival was analyzed using Kaplan-Meier (KM) method procedures at 66 months (phase 2) and 24 months (phase III). The two-sided 95% confidence intervals (CI) for the estimated rates of patients alive at end of study (EOS) was calculated using Greenwood's formula. Start, event and censor times for the Kaplan-Meier analyses of participant survival were (Event time: day of death, Censor Time: day of last follow-up (for participants prematurely withdrawn from the study), and day of last
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 |
What the finished NCT02118896 record still lists
NCT02118896 is an interventional study that assigns participants to a tested intervention. The registered 850 participants enrollment target is mid-sized for trials with a published cap, above the 242-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (251% higher).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
Similar trials for Kidney Transplantation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02118896's enrollment target sits among peer trials
850 2nd of 33 the highest of 33 other Kidney Transplantation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Transplantation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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