Clinical trial • Immunology|Nephrology

TACROLIMUS for Pediatric kidney transplant recipients|Kidney transplantation

Clinical trial of TACROLIMUS for Pediatric kidney transplant recipients|Kidney transplantation. 28 participants.

Overview

Trial Therapeutic Area
Immunology|Nephrology
Trial Disease
Pediatric kidney transplant recipients|Kidney transplantation
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
13-06-2024
First CTIS Authorization Date
28-06-2024

Trial design

Clinical trial across 2 sites in Netherlands.

Target Sample Size
28

Eligibility

Recruits 28 paediatric patients.

Vulnerable Population
Participants are children aged 2-18 years; inclusion requires "Signed written informed consent." No further details on assent, parental consent procedures or additional vulnerable-population handling are provided in the record; isVulnerablePopulationSelected=false.

Inclusion criteria

  • {"criterion_text":"- Age 2-18 years old\n- Patients to be transplanted with a kidney allograft\n- Patients receiving a kidney from a blood group ABO-compatible donor\n- Patients who will receive tacrolimus as part of their initial immunosuppressive therapy\n- Signed written informed consent."}

Exclusion criteria

  • {"criterion_text":"- Recipients of a non-renal organ transplant at the same occasion\n- Recipients of a blood group ABO-incompatible kidney allograft\n- Recipients of an HLA-incompatible kidney allograft (positive cross-match)\n- Recipients receiving tacrolimus as immunosuppressive treatment within the preceding 28 days.\n- Recipients using medication known to have a pharmacokinetic (drug-drug) interaction with tacrolimus (see Appendix I, table 1 for specification).\n- Extra exclusion criteria for participation in study part B: Children who are not able to swallow a once-daily tacrolimus capsule\n- Extra exclusion criteria for participation in study part B: Children with changes in the administration of drugs interacting with tacrolimus around the switch to the once-daily formulation."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The percentage of children within the target C0 range of tacrolimus (10-15 ng/mL) on day 3 after kidney transplantation following algorithm-based dosing","definition_or_measurement_approach":"Measured as the percentage of participants whose tacrolimus trough concentration (C0) is within 10-15 ng/mL on day 3 after transplantation following algorithm-based dosing."}

Recruitment

Planned Sample Size
28
Recruitment Window Months
27
Consent Approach
Signed written informed consent is required. No further details on assent, parental consent processes, age-specific documents, or languages are provided in the record.

Geography

Total Number Of Sites
2
Total Number Of Participants
28

Netherlands

Earliest CTIS Part Ii Submission Date
20-06-2024
Latest Decision Or Authorization Date
28-06-2024
Processing Time Days
8
Number Of Sites
2
Number Of Participants
28

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Pediatrics
Principal Investigator Name
Huib de Jong
Principal Investigator Email
h.dejong@erasmusmc.nl
Contact Person Name
Huib de Jong
Contact Person Email
h.dejong@erasmusmc.nl
Site Name
Radboud universitair medisch centrum / RADBOUDUMC
Department Name
Pediatrics
Principal Investigator Name
Marlies Cornelissen
Principal Investigator Email
Marlies.Cornelissen@radboudumc.nl
Contact Person Name
Marlies Cornelissen

Sponsor

Primary sponsor

Full Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
Envarsus 0.75 mg prolonged-release tablets
Active Substance
TACROLIMUS
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation number: EU/1/14/935/001
Maximum Dose
50 mg
Investigational Product Name
Envarsus 4 mg prolonged-release tablets
Active Substance
TACROLIMUS
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation number: EU/1/14/935/007
Maximum Dose
50 mg
Investigational Product Name
Envarsus 1 mg prolonged-release tablets
Active Substance
TACROLIMUS
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation number: EU/1/14/935/004
Maximum Dose
50 mg
Investigational Product Name
Modigraf 1 mg granules for oral suspension
Active Substance
TACROLIMUS
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation number: EU/1/09/523/002
Maximum Dose
50 mg
Investigational Product Name
PROGRAF 5 mg capsule
Active Substance
TACROLIMUS
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation number: 8913/2016/02
Maximum Dose
50 mg
Investigational Product Name
Modigraf 0.2 mg granules for oral suspension
Active Substance
TACROLIMUS
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation number: EU/1/09/523/001
Maximum Dose
50 mg
Investigational Product Name
PROGRAF 0,5 mg capsule
Active Substance
TACROLIMUS
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation number: 8911/2016/02
Maximum Dose
50 mg
Investigational Product Name
PROGRAF 1 mg capsule
Active Substance
TACROLIMUS
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation number: 8912/2016/02
Maximum Dose
50 mg

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