kidney fuction in livertransplantation patients
Conditions
Interventions
Immunologically stable liver transplant recipients will be converted from a cyclosporine based regimen to a standard C0 measured tacrolimus based regimen with a target level of 4-8 ng/mg.
Following a
Sponsors
MD. PhD. B. van Hoek
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient age 18 years or older 2. Recieved a calcineurin-based immunosuppressive regimen since last transplantation 3. Patient is recipent of a liver transplant at least 6 months to entry into the study 4. Immunosuppressive regimen (combination of medications) remained unchanged for a minimum of 4 weeks prior to enrolment 5. Female patients of child bearing potential must have a negative urine of serum pregnacy test prior to enrolment and must agree to practice effctive birth control during the study 6. Patients capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Multi- organ transplant recipients 2. Patients with serum creatinine> 200umol/l 3. Patients known to be HIV positive 4. Patients allergic or intolerant to macrolide antibiotics or tacrolimus 5. Patients with systemic infection requiring treatment, except viral hepatitis 6. Patients with severe diarrhoea, vomitting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus 7. Patients requiring parallel therapy with immunosuppressive antibody preparations 8. Patients with any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator 9. Patients participating or having partictpated in another clinical trial and/or those taking or having taken an investigational / non-registreteddrug in the past 28 days 10. Patients who are pregnant or breast-feeding mother 11. Patients unlikely to comply with the visits scheduled in the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - creatinine clearance calculated by BSA- corrected Cockcroft and Gault and MDRD between: - baseline ( day 1) and week 12 ( end of C0) - week 12 (end of C0) and week 24 (end of study) - baseline (day 1) and week 24 ( end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| - safety - 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 study) - tacrolimus pharmacokinetics - 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) - tacrolimus pharmacokinetics - subjects and graft survival - side effects - biopsy proven treated graft rejection | — |
Contacts
Public ContactLida Beneken Kolmer
Leiden University Medical Center (LUMC) Department of Gastroenterology and Hepatology C4P room 15 P.O. Box 9600
Outcome results
None listed