kidney transplantation
Conditions
Interventions
Trade Name: Prograft
Product Name: Prograft
Pharmaceutical Form: Capsule
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years old • Patients receiving a kidney from a living donor (related or unrelated) • Patients receiving a kidney from a blood group AB0-compatible donor • Patients receiving a kidney form an HLA-compatible donor (non-desensitized patients) • Patients who will receive tacrolimus as part of the initial immunosuppressive therapy • Signed written informed consent 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 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: • Recipients of a non-renal organ transplant at the same occasion • Recipients receiving immunosuppressive therapy (except steroid treatment) within the preceding 28 days. • Recipients using medication known to have a pharmacokinetic interaction with tacrolimus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To minimize the occurrence of sub-therapeutic and supra-therapeutic C0 of tacrolimus on day 3 after transplantation by basing the starting dose of tacrolimus on a dosing algorithm, rather than the standard bodyweight-only-based approach. More specifically, we will investigate whether a tacrolimus starting dose based on the algorithm will lead to a sufficient percentage of patients being within the tacrolimus target C0 on day 3 after transplantation, w.r.t. the percentage found in one historic control group of patients who have received a standard starting dose of tacrolimus; in that case a randomized trial might be an option.; Secondary Objective: We will also describe: • The percentage of patients with extremely high or low tacrolimus C0 on day 3 after transplantation; • The percentage of patients within the target C0 on days 5, 7 and 10 after transplantation; • The time to achievement of tacrolimus target C0; • Incidence of BPAR and (serious) adverse events within the first 30 days after transplantation; • The relationship between the intracellular tacrolimus concentration in PBMCs and the whole blood concentration and compare them with those observed in the historic control group which could add to the decision to perform a randomized trial. ;Primary end point(s): The main study endpoint of the study is the proportion of patients reaching the target C0 (7.5-12.5 ng/mL) on day 3 after transplantation.;Timepoint(s) of evaluation of this end point: 3 days after transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The proportion of patients reaching the target C0 (7.5-12.5 ng/mL) on day 5, 7 and 10. • The proportion of patients with markedly supra- (>20 ng/mL) or sub-therapeutic (<5 ng/mL) tacrolimus C0 on day 3 after transplantation. • The time to reach the target C0 (7.5-12.5 ng/mL). • Incidence of BPAR and (serious) adverse events within the first 30 days after transplantation. • The relationship between the intracellular tacrolimus concentration in PBMCs and the whole blood concentration ; Timepoint(s) of evaluation of this end point: 3, 5, 7 and 10 days after transplantation. The incidence of BPAR will be evaluated the first 30 days after transplantation | — |
Countries
Netherlands
Contacts
Public ContactDennis Hesselink
Erasmus MC
Outcome results
None listed