Kidney transplantation MedDRA version: 12.1 Level: LLT Classification code 10038474 Term: Renal insufficiency
Conditions
Interventions
Trade Name: Prograft
Product Name: Prograft
Pharmaceutical Form: Capsule*
INN or Proposed INN: Prograft
CAS Number: 104987-11-3
Current Sponsor code: 18107
Other descriptive name: tacrolimus
Concentra
Sponsors
Erasmus Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult recipients (18 years or older) who are to receive an ABO-compatible single-organ kidney transplant from a living donor (related or unrelated) will be eligible for entry into the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients receiving immunosuppressive therapy (except steroid treatment) within the preceding 28 days except for pretransplant immunosuppressive medication (up to 48 hr before transplantation) will not be included. In addition, patients using medication known to have a pharmacokinetic interaction with tacrolimus will not be asked to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: First we will investigate whether a CYP3A5 genotype-based tacrolimus dosing strategy will result in improved clinical outcomes as compared with a standard tacrolimus dosing regimen based on bodyweight. ;Secondary Objective: Second, we will investigate if ABCB1 and CYP3A5 and single-nucleotide polymorphisms (SNPs) in their encoding genes are associated with the development of tacrolimus-induced nephrotoxicity after kidney transplantation.;Primary end point(s): The primary endpoint of the study is the proportion of patients reaching target levels (10-15 ng/ml) on day 3 and day 7 after transplantation. | — |
Countries
Netherlands
Outcome results
None listed