A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients

Condition(s) targeted: Liver Transplantation

Intervention: tacrolimus modified release (MR) (Drug); tacrolimus (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Central Contact, Study Director, Affiliation: Astellas Pharma US, Inc.

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.

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus

Minimum Observed Concentration of Tacrolimus (Cmin)

Patient Survival

Graft Survival

Secondary outcome:

Maximum Observed Concentration of Tacrolimus (Cmax)

Time to Maximum Observed Concentration of Tacrolimus (Tmax)

Percentage of Participants With Biopsy-confirmed Acute Rejection

Time to Event for Patient Non-survival

Time to Event for Graft Non-survival

Time to First Biopsy-confirmed Acute Rejection

Grade of Biopsy-confirmed Acute Rejection Episodes

Number of Participants Receiving Anti-lymphocyte Antibody Therapy for Acute Rejection

Number of Participants With Multiple Rejection Episodes

Number of Participants With Clinically Treated Acute Rejection Episodes

Number of Participants With Chronic Rejection

Number of Participants With Treatment Failure

Primary Reason for Graft Loss

Safety as Assessed by Clinical Signs and Symptoms, Laboratory Parameters and Diagnostic Tests

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.

Minimum age: N/A. Maximum age: 12 Years. Gender(s): Both.

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.

Atlanta, Georgia 30322, United States

Indianapolis, Indiana 46202, United States

New Orleans, Louisiana 70433, United States

New York, New York 10029, United States

Madison, Wisconsin 53792, United States

Related publications:

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.

Starting date: January 2004
Last updated: August 12, 2013