Primary objective: - evaluation and comparison of the intra- and interpatient variability for the Area under the curve (AUC) of orally administered Tac BID and Tac QD in stable renal transplant patients. Secondary objective: - evaluation and…
ID
Source
Brief title
Condition
- Urethral disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- intra- and interpatientvariability of the Area Under the Curve (AUC) for
orally administered Tacrolimus.
Secondary outcome
- tacrolimus maximum concentration (Cmax) and its intra- and
interpatientvariability;
- time to reach Cmax (Tmax) and its intra- and interpatientvariability;
- tacrolimus trough level (Cmin) and its intra- and interpatientvariability;
- CYP3A5 genotype;
- questionnaires on health status and quality of life
- transplant function (endogeneous creatinine clearance
- use of co-medication
- the change in tacrolimus bloodlevels (AUC) when Advagraf is administered
together with a continental breakfastI (only patients participating in
amendment 2 (AUC tacrolimus intake together with breakfast)
Background summary
A modified-release formulation of Tacrolimus, a potent immuno-suppressor, has
been developed which has to be taken once daily (Tac QD, Advagraf) instead of
twice daily as is the case with the immediate-release formulation of Tacrolimus
(Tac BID, Prograft). This has been developed to enhance therapy adherence.
However we do not know whether patients really appreciate a once-daily
formulation, which may be related to the use of sometimes extensive
co-medication. Secondly, intra- and interpatient variability of Tac QD have not
been reported yet in stable renal transplant recipients. Third, the observed
reduced intra-patient variability in afro-american de novo kidney patients may
have a genetic background. We would like to study these three aspects in a
population of stable renal transplant recipients before and after conversion to
the Tac QD.
In patient participating in the study as described in amendment 2 (AUC
tacrolimus intake together with breakfast) the change in tacrolimus bloodlevels
(AUC) are examined when Advagraf is administered together with a continental
breakfast.
Study objective
Primary objective:
- evaluation and comparison of the intra- and interpatient variability for the
Area under the curve (AUC) of orally administered Tac BID and Tac QD in stable
renal transplant patients.
Secondary objective:
- evaluation and comparison of the intra- and interpatient variability for
other pharmacokinetic parameters of orally administered Tac BID and Tac QD in
stable renal transplant patients.
- Pooling of these data towards the patients* CytochromeP450 3A5 (CYP3A5)
genotype;
- evaluation of the patients*s perception on his/her health status and quality
of life to before and after conversion to Tac QD
- Evaluation of the change in tacrolimus bloodlevels (AUC) when Advagraf is
administered together with a continental breakfastI (only patients
participating in amendment 2 (AUC tacrolimus intake together with breakfast)
Study design
An open label, single centre conversion study
Intervention
Conversion from Prograf to Advagraf
Study burden and risks
risk:
There are no risks associated with participation: conversion from Prograf to
Advagraf has been shown to be safe and effective. Advagraf has been registered
for the same indication as Prograf. In fact the conversion is part of our
regular patient care coupled to additional scientific research.
burden:
The participant will be screened before definite inclusion on our outpatient
clinic. This stands for one surplus visit to our centre. Furthermore, patients
will be asked to compose 8-point tacrolimus profiles with weekly intervals
during two 6-week periods (i.e. 12 profiles). The profiles will be composed by
means of capillary blood sampling, the Blood Spot method. This is a validated
method for the determiantion of tacrolimus blood concetrations. Besides, a
questionnaire will have to be completed twice, before and after conversion to
Advagraf.
P.Debyelaan 25
6229 HX Maastricht
Nederland
P.Debyelaan 25
6229 HX Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
· 18 years of age or older
· stable renal allograft function
· immunosuppression with Tac BID (Prograft)
· part of the population is selected on base of already known CYP3A5 SNP*s (carrier or homozygous for CYP3A5*1) to ensure inclusion of an adequate amount of patients with an increased metabolism of tacrolimus.
Exclusion criteria
· graft failure
· other organ transplanted than kidney
· malignancy
· renal replacement therapy (RRT)
· sign of infection before inclusion
· patients already taking Tac QD
.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | 1791 |
| EudraCT | EUCTR2009-010400-28-NL |
| CCMO | NL26976.068.09 |
| OMON | NL-OMON29529 |