Clinical trial NCT00282256: A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients
Official title: A Phase 2, Open-Label, Multi-center Study to Assess the Pharmacokinetics, Long-Term Safety and Tolerability of Tacrolimus in Stable Pediatric Liver Transplant Patients Converted From a Prograf® Based Immunosuppression Regimen to a Modified Release (MR) Tacrolimus Based Immunosuppression Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Transplantation
Keywords: Child
Pharmacokinetics
Immunosuppression Drugs
Hepatic transplant
Liver Transplantation
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-01-26
Enrollment: 19
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed description: A 1 arm study to assess the pharmacokinetics, and long-term safety and effectiveness of a modified release tacrolimus based immunosuppression regimen in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen.

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.

Primary outcomes:
measure: Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus
timeFrame: For tacrolimus, Day 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Day 14 at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.
measure: Minimum Observed Concentration of Tacrolimus (Cmin)
timeFrame: Day 7 at 12 hours post-dose (tacrolimus) and Day 14 at 24 hours post-dose (tacrolimus MR).
measure: Patient Survival
timeFrame: From enrollment until the end of study (up to 54 months).
measure: Graft Survival
timeFrame: From enrollment until the end of study (up to 54 months).
Secondary outcomes:
measure: Maximum Observed Concentration of Tacrolimus (Cmax)
timeFrame: For tacrolimus, Day 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Day 14 at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.
measure: Time to Maximum Observed Concentration of Tacrolimus (Tmax)
timeFrame: For tacrolimus, Day 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Day 14 at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.
measure: Percentage of Participants With Biopsy-confirmed Acute Rejection
timeFrame: From enrollment until the end of study (up to 54 months).
measure: Time to Event for Patient Non-survival
timeFrame: From enrollment until the end of study (up to 54 months).
measure: Time to Event for Graft Non-survival
timeFrame: From enrollment until the end of study (up to 54 months).
measure: Time to First Biopsy-confirmed Acute Rejection
timeFrame: From enrollment until the end of study (up to 54 months).
measure: Grade of Biopsy-confirmed Acute Rejection Episodes
timeFrame: From enrollment until the end of study (up to 54 months).
measure: Number of Participants Receiving Anti-lymphocyte Antibody Therapy for Acute Rejection
timeFrame: From enrollment until the end of study (up to 54 months).
measure: Number of Participants With Multiple Rejection Episodes
timeFrame: From enrollment until the end of study (up to 54 months).
measure: Number of Participants With Clinically Treated Acute Rejection Episodes
timeFrame: From enrollment until the end of study (up to 54 months).
measure: Number of Participants With Chronic Rejection
timeFrame: From enrollment until the end of study (up to 54 months).
measure: Number of Participants With Treatment Failure
timeFrame: From enrollment until the end of study (up to 54 months).
measure: Primary Reason for Graft Loss
timeFrame: From enrollment until the end of study (up to 54 months).
measure: Safety as Assessed by Clinical Signs and Symptoms, Laboratory Parameters and Diagnostic Tests
timeFrame: From the first dose of tacrolimus MR formulation through the last dose day plus 10 days (approximately 54 months).
Other outcomes:
Locations:
city: Atlanta
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: New Orleans
country: United States
state: Louisiana
city: New York
country: United States
state: New York
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Central Contact
role: STUDY_DIRECTOR
References:
citation: Heffron TG, Pescovitz MD, Florman S, Kalayoglu M, Emre S, Smallwood G, Wisemandle K, Anania C, Dhadda S, Sawamoto T, Keirns J, Fitzsimmons W, First MR. Once-daily tacrolimus extended-release formulation: 1-year post-conversion in stable pediatric liver transplant recipients. Am J Transplant. 2007 Jun;7(6):1609-15. doi: 10.1111/j.1600-6143.2007.01803.x.