Phase 2
Completed N=70
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Liver Transplant Patients
Source: ClinicalTrials.gov NCT00282243 ↗Enrolled (actual)
70
Serious AEs
53.6%
Results posted
Sep 2013
Primary outcomePrimary: Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus — 215.6; 184.0; 202.4; 187.9 ng*hr/mL
Summary
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable liver transplant patients converted from a tacrolimus (Prograf®) based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus |
215.6; 184.0; 202.4; 187.9 | — |
| PRIMARY Minimum Observed Concentration of Tacrolimus (Cmin) |
7.1; 5.5; 6.8; 5.8 | — |
| PRIMARY Patient Survival |
92.31 | — |
| PRIMARY Graft Survival |
90.77 | — |
| SECONDARY Maximum Observed Concentration of Tacrolimus (Cmax) |
17.9; 13.3; 16.0; 14.1 | — |
| SECONDARY Time to Maximum Observed Concentration of Tacrolimus (Tmax) |
2.8; 3.0; 3.0; 2.7 | — |
| SECONDARY Percentage of Participants With Biopsy-confirmed Acute Rejection |
9.23 | — |
| SECONDARY Time to Event for Patient Non-survival |
1561.00 | — |
| SECONDARY Time to Event for Graft Non-survival |
1529.50 | — |
| SECONDARY Time to First Biopsy-confirmed Acute Rejection |
802.50 | — |
| SECONDARY Grade of Biopsy-confirmed Acute Rejection Episodes |
4; 2; 0 | — |
| SECONDARY Number of Participants Receiving Anti-lymphocyte Antibody Therapy for Acute Rejection |
1 | — |
| SECONDARY Number of Participants With Multiple Rejection Episodes |
2 | — |
| SECONDARY Number of Participants With Clinically Treated Acute Rejection Episodes |
5 | — |
| SECONDARY Number of Participants With Chronic Rejection |
— | — |
| SECONDARY Number of Participants With Treatment Failure |
— | — |
| SECONDARY Primary Reason for Graft Loss |
1; 5 | — |
| SECONDARY Change From Baseline in Alanine Aminotransferase (ALT) |
38.5; 14.4; 13.3 | — |
| SECONDARY Change From Baseline in Aspartate Aminotransferase (AST) |
33.4; 3.6; 10.6 | — |
| SECONDARY Change From Baseline in Total Bilirubin |
0.74; 0.03; 1.04 | — |
| SECONDARY Safety as Assessed by Adverse Events, Laboratory Parameters and Vital Signs |
63; 37; 18; 37; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is currently receiving Prograf ® based immunosuppressive therapy for liver transplantation.
- Patient has stable whole blood trough level concentrations of Prograf® and is clinically stable
Exclusion Criteria
- Patient has previously received an organ transplant other than a liver
- Patient is currently receiving sirolimus immunosuppression therapy.
Data sourced from ClinicalTrials.gov (NCT00282243). 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.