An open-label, single centre study to assess and compare the intra- and interpatientvariability in the oral bioavailability for Immediate-Release Tacrolimus and after conversion to Modified-Release Tacrolimus in stable kidney transplant recipients.

An open-label, single centre study to assess and compare the intra- and interpatientvariability in the oral bioavailability for Immediate-Release Tacrolimus and after conversion to Modified-Release Tacrolimus in stable kidney transplant recipients. - Advagraf Conversion Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35391

Enrollment

Registered

2009-03-20

Start date

2010-05-17

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

kidney transplantation renal transplant

Interventions

Conversion from Prograf to Advagraf

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
- intra- and interpatientvariability of the Area Under the Curve (AUC) for orally administered Tacrolimus.	—

Secondary

Measure	Time frame
- 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)	—

Measure

Time frame

- 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)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)