conversion from cyclosporine to tacrolimus followed by randomized C0 or Bayesian monitoring using the C4 time point . The effect on kidney function.
Completed
- Conditions
- Livertransplantantion patients10019654
- Registration Number
- NL-OMON31971
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
patient age 18 years or older
recieved a calcineurin-based immunosuppressive regimen since last transplantation
patient is recipient of a liver transplant at least 6 months prior to entry into the study
Exclusion Criteria
multi-organ transplant recipients
patients with serum creatinine > 200umol/l
patients known to be HIV positive
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>changing in renalfunction</p><br>
- Secondary Outcome Measures
Name Time Method <p>- safety<br /><br>- changing in mean arterial blood pressure and number and dose of<br /><br>antihypertensive medications used between baseline (day 1) week 12(end of C0)<br /><br>and week 24 ( end of study)<br /><br>- Tacrolimus pharmacokinetics<br /><br>- changing in mean lipid levels( total cholesterol, TG, HDL and LDL) and<br /><br>number and dose of lipid-lowering medications between Baseline ( Day 1) week 12<br /><br>( end of C0) and week 24 ( end of study)</p><br>