Phase 2
Completed N=19
A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients
Source: ClinicalTrials.gov NCT00282256 ↗Enrolled (actual)
19
Serious AEs
33.3%
Results posted
Oct 2013
Primary outcomePrimary: Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus — 198.2; 193.0 ng*hr/mL
Summary
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable pediatric liver transplant patients converted from a 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 |
198.2; 193.0 | — |
| PRIMARY Minimum Observed Concentration of Tacrolimus (Cmin) |
5.9; 5.3 | — |
| PRIMARY Patient Survival |
94.44 | — |
| PRIMARY Graft Survival |
94.44 | — |
| SECONDARY Maximum Observed Concentration of Tacrolimus (Cmax) |
20.7; 15.2 | — |
| SECONDARY Time to Maximum Observed Concentration of Tacrolimus (Tmax) |
1.0; 2.0 | — |
| SECONDARY Percentage of Participants With Biopsy-confirmed Acute Rejection |
16.67 | — |
| SECONDARY Time to Event for Patient Non-survival |
1204.00 | — |
| SECONDARY Time to Event for Graft Non-survival |
1203.00 | — |
| SECONDARY Time to First Biopsy-confirmed Acute Rejection |
748.00 | — |
| SECONDARY Grade of Biopsy-confirmed Acute Rejection Episodes |
2; 1; 0 | — |
| SECONDARY Number of Participants Receiving Anti-lymphocyte Antibody Therapy for Acute Rejection |
— | — |
| SECONDARY Number of Participants With Multiple Rejection Episodes |
1 | — |
| SECONDARY Number of Participants With Clinically Treated Acute Rejection Episodes |
3 | — |
| SECONDARY Number of Participants With Chronic Rejection |
— | — |
| SECONDARY Number of Participants With Treatment Failure |
— | — |
| SECONDARY Primary Reason for Graft Loss |
0; 1 | — |
| SECONDARY Safety as Assessed by Clinical Signs and Symptoms, Laboratory Parameters and Diagnostic Tests |
12; 1; 6; 3; 1 | — |
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 (NCT00282256). 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.