|- candidate number||28304|
|- NTR Number||NTR6864|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-dec-2017|
|- Secondary IDs||NL61720.078.17 2017-001681-24|
|- Public Title||Avoiding tacrolimus under- and overexposure by using a dosing algorithm for pediatric renal transplant recipients|
|- Scientific Title||Avoiding tacrolimus under- and overexposure by using a dosing algorithm for pediatric renal transplant recipients|
|- hypothesis||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. |
|- Healt Condition(s) or Problem(s) studied||Renal transplant |
|- 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
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||20-nov-2017|
|- planned closingdate||1-apr-2019|
|- Target number of participants||28|
|- Interventions||Tacrolimus starting dose based on a dosing algorithm|
|- 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.
|- Timepoints||Day 3, 7 and 10 following transplantation|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Karlien Cransberg|
|- CONTACT for SCIENTIFIC QUERIES|| Karlien Cransberg|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Stichting De Merel|
|- Brief 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.
|- Main changes (audit trail)|
|- RECORD||5-dec-2017 - 14-dec-2017|