Pharmacokinectics of Sirolimus and Tacrolimus in Liver Transplant Recipients With Early Nephrotoxicity and/or Hypertension Due to Tacrolimus
Phase 2/Phase 3
N/A
N/A
N/A
N/A
Not Enrolling
Both
Hypertension
Both
Hypertension
Trial Information
Pharmacokinectics of Sirolimus and Tacrolimus in Liver Transplant Recipients With Early Nephrotoxicity and/or Hypertension Due to Tacrolimus
The study plans to collect Pharmacokinetic data for Tacrolimus and Sirolimus alone and in
combination.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Acute rejection - incidence and severity-
Outcome Time Frame:
3 months
Safety Issue:
Yes
Principal Investigator
Rakesh Sindhi
Investigator Role:
Principal Investigator
Investigator Affiliation:
UPitt
Authority:
United States: Institutional Review Board
Study ID:
07100379
NCT ID:
NCT01709136
Start Date:
December 2005
Completion Date:
January 2010
Related Keywords:
- Hypertension
- Hypertension
Name | Location |
|---|
