search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Avoiding tacrolimus under- and overexposure by using a dosing algorithm for pediatric renal transplant recipients


- candidate number28304
- NTR NumberNTR6864
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-dec-2017
- Secondary IDsNL61720.078.17 2017-001681-24
- Public TitleAvoiding tacrolimus under- and overexposure by using a dosing algorithm for pediatric renal transplant recipients
- Scientific TitleAvoiding tacrolimus under- and overexposure by using a dosing algorithm for pediatric renal transplant recipients
- ACRONYM
- hypothesisThe 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) studiedRenal transplant
- Inclusion criteria1: 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 criteria1: 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 receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 20-nov-2017
- planned closingdate1-apr-2019
- Target number of participants28
- InterventionsTacrolimus starting dose based on a dosing algorithm
- Primary outcomeThe main study endpoint of the study is the proportion of patients reaching the target C0 (10-15 ng/mL) on day 3.
- Secondary outcomeSecondary 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.
- TimepointsDay 3, 7 and 10 following transplantation
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Karlien Cransberg
- CONTACT for SCIENTIFIC QUERIES Karlien Cransberg
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Stichting De Merel
- PublicationsN/A
- 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)
- RECORD5-dec-2017 - 14-dec-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl