Conversion from cyclosporine to tacrolimus followed by randomized C0 or C4 Bayesian monitoring stable liver transplant patients.
- Conditions
- kidney fuction in livertransplantation patients
- Registration Number
- NL-OMON22214
- Lead Sponsor
- MD. PhD. B. van Hoek
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
1. Patient age 18 years or older
2. Recieved a calcineurin-based immunosuppressive regimen since last transplantation
Exclusion Criteria
1. Multi- organ transplant recipients
2. Patients with serum creatinine> 200umol/l
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - creatinine clearance calculated by BSA- corrected Cockcroft and Gault and MDRD between:<br /><br>- baseline ( day 1) and week 12 ( end of C0)<br /><br>- week 12 (end of C0) and week 24 (end of study)<br /><br>- baseline (day 1) and week 24 ( end of study
- Secondary Outcome Measures
Name Time Method - safety<br /><br>- changing in mean arterial bloodpressure and number and dose of antihypertension medications usedbetween baseline(day 1) week 12 ( end of C0) and week 24 (end of <br>study)<br /><br>- tacrolimus pharmacokinetics<br /><br>- changing in mean lipid levels (total cholesterol, TG, HDL and LDL) and number and dose of lipid-lowering medications between Baseline (Day 1) week 12 (end of C0) and week 24 (end of study)<br /><br>- tacrolimus pharmacokinetics<br /><br>- subjects and graft survival<br /><br>- side effects<br /><br>- biopsy proven treated graft rejection