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-…
ID
Bron
Aandoening
Renal transplantation
Niertransplantatie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The main study endpoint of the study is the proportion of patients reaching the target C0 (10-15 ng/mL) on day 3.
Achtergrond van het onderzoek
- 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.
Doel van het onderzoek
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.
Onderzoeksopzet
Day 3, 7 and 10 following transplantation
Onderzoeksproduct en/of interventie
Tacrolimus starting dose based on a dosing algorithm
Publiek
Dr Molewaterplein 60
Karlien Cransberg
Dr Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636363
k.cransberg@erasmusmc.nl
Wetenschappelijk
Dr Molewaterplein 60
Karlien Cransberg
Dr Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636363
k.cransberg@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6694 |
| NTR-old | NTR6864 |
| CCMO | NL61720.078.17 |
| OMON | NL-OMON44606 |