Phase 3
Completed N=850
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
Source: ClinicalTrials.gov NCT02118896 ↗Enrolled (actual)
850
Serious AEs
38.5%
Results posted
Mar 2016
Primary outcomePrimary: Participant Survival — 0.9092; 1.0000; 0.9356; 0.9031 survival probability
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant Survival |
0.9092; 1.0000; 0.9356; 0.9031; 0.9536; 0.9933 | — |
| PRIMARY Graft Survival |
0.9092; 1.0000; 0.9217; 0.9031; 0.9536; 0.9469 | — |
| SECONDARY Biopsy-confirmed Acute Rejection (BCAR) Episodes |
3; 3; 0; 9; 5; 1 | — |
| SECONDARY Time to First BCAR Episode |
479.3; 358; 601.2; 89.6; 1; 192 | — |
| SECONDARY Number of Participants With Adverse Events |
47; 47; 67; 73; 130; 180 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Pregnant women or nursing mothers.
- Women unwilling or unable to use adequate contraception during the study.
Data sourced from ClinicalTrials.gov (NCT02118896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.