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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
NCT02118896 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 850 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Europe, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02118896 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, Victoria, Ontario. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02118896?
The interventions under investigation include: FK506E (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02118896?
This trial is sponsored by Astellas Pharma Europe, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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