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van CCT (UK)

van CCT (UK)

Conversion from cyclosporine to tacrolimus followed by randomized C0 or C4 Bayesian monitoring stable liver transplant patients.

- candidate number3551
- NTR NumberNTR1366
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-jul-2008
- Secondary IDsCME code is: P08.089 
- Public TitleConversion from cyclosporine to tacrolimus followed by randomized C0 or C4 Bayesian monitoring stable liver transplant patients.
- Scientific TitleConversion from cyclosporine to tacrolimus followed by randomised C0 or C4 bayesian monitoring stable liver transplant patients
- hypothesisRenal function improves when converting stable livertransplant patients from cyclosporin to tacrolimus; it also improves with Bayesian C4 monitoring compared to C0 monitoring on tacrolimus.
- Healt Condition(s) or Problem(s) studiedLiver transplantation, Kidney fuction, Tacrolimus, Cyclosporine
- Inclusion criteria1. 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 criteria1. 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-sep-2008
- planned closingdate1-sep-2009
- Target number of participants50
- InterventionsImmunologically 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 three month period in which the effect of the switch in immunosuppressive regimen will be observed and the dose can stabilize, patients will be randomized on a 50%/50% bases, one group continuing the standard C0 measurement tacrolimusregimen, the other will be dosed accoring to equipotent C4 AUC levels of 90-130 ng*h/ml.
Patients already on tacrolimus can enter the study as a separate stratum in week 12. During the following three months the effect of the C4 dosing will be compared tot the C0 dosing.
The total duration of the study is six months.
- Primary outcome- 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 outcome- 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
- Timepoints- week 0
- week 1
- week 3
- week 8
- week 12
- week 16
- week 20
- week 24
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Gastroenterology and Hepatology
- Funding
(Source(s) of Monetary or Material Support)
Astellas Pharma B.V
- PublicationsN/A
- Brief summaryWe convert stable patients after liver transplantation from cyclosporin to tacrolimus. Then patients on tacrolimus are randomized to monitoring by C0 or by Bayesian C4 blood levels. Primary outcome measure is renal function.
- Main changes (audit trail)
- RECORD3-jul-2008 - 10-okt-2008

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