Pharmacokinetics of Sirolimus and Tacrolimus in Liver Transplant Recipients With Tacrolimus Toxicity

• Status: Terminated
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Pharmacokinetics of Tacrolimus and Sirolimus alone and in combination in liver transplant recipients.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Treatments: Everolimus; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• Recipients of primary liver (cadaver/liver, whole/segmental) transplants 5- 30 years old.

• Rejection-free post-transplant course for at least 3 months

• Renal dysfunction (15% decrease in age-adjusted calculated creatinine clearance)

• Hypertension requiring anti-hypertensive mediations.

• Informed consent.

• Weight ≥15 kg.

Exclusion Criteria:

• Rejection or infections within 3 months of enrollment.

• Intent to continue TAC

• Active participation in ongoing studies of immunosuppressive agents.

• Lack of informed consent.

• Pregnant or breast feeding

• HIV positive