No registrations found.
ID
Source
Health condition
Renal transplantation
Niertransplantatie
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint of the study is the proportion of patients reaching the target C0 (10-15 ng/mL) on day 3.
Secondary outcome
Secondary study endpoints of the study are:
1: The proportion of patients reaching the target C0 (10-15 ng/mL) on day 7 and 10.
2: The proportion of patients with markedly supra- (>20 ng/mL) or sub-therapeutic (<5 ng/mL) tacrolimus C0 on day 3 after transplantation.
3: The time to reach the target C0 (10-15 ng/mL).
4: Incidence of BPAR and (serious) adverse events within the first 10 days after transplantation.
Background summary
- Objective: The key objective is to minimize the occurrence of subtherapeutic and supra-therapeutic C0 of tacrolimus by basing the starting dose on the dosing algorithm.
- Study design: Prospective, multi-centre, single-arm, therapeutic intervention study
- Study population: Pediatric de novo kidney transplant recipients.
- Intervention: All participants will receive the tacrolimus starting dose based on a dosing algorithm which takes genetic, demographic and clinical factors into account, rather than the standard bodyweight-based dose.
- Main study parameters/endpoints: The main study parameter is the percentage of children within the target C0 range of tacrolimus (10-15 ng/mL) on day 3 after kidney transplantation.
- Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no extra burden for the included children.
Study objective
The key objective is to minimize the occurrence of sub-therapeutic and supra-therapeutic C0 of tacrolimus on days 3, 7 and 10 after transplantation by basing the starting dose of tacrolimus on a dosing algorithm, rather than the standard bodyweight-only-based approach.
Study design
Day 3, 7 and 10 following transplantation
Intervention
Tacrolimus starting dose based on a dosing algorithm
Dr Molewaterplein 60
Karlien Cransberg
Dr Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636363
k.cransberg@erasmusmc.nl
Dr Molewaterplein 60
Karlien Cransberg
Dr Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636363
k.cransberg@erasmusmc.nl
Inclusion criteria
1: Age 2-18 years old
2: Patients to be transplanted with a kidney allograft
3: Patients receiving a kidney from a blood group AB0-compatible donor
4: Patients who will receive tacrolimus as part of the initial immunosuppressive therapy
Exclusion criteria
1: Recipients of a non-renal organ transplant at the same occasion
2: Recipients of a blood group AB0-incompatible kidney allograft
3: Recipients receiving immunosuppressive therapy (except steroid treatment) within the preceding 28 days.
4: Recipients using medication known to have a pharmacokinetic interaction with tacrolimus
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6694 |
| NTR-old | NTR6864 |
| CCMO | NL61720.078.17 |
| OMON | NL-OMON44606 |