Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
28
Countries
1
Sites
2
pediatric kidney transplant recipients
The key objective is to personalize tacrolimus treatment for children with a renal transplant by using dosing algorithms to calculate both the individual’s tacrolimus starting dose and follow-up doses.
Key facts
- Sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Decision date (initial)
- 2024-06-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511585-36-00
- EudraCT number
- 2021-006481-21
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Therapy, Pharmacokinetic
The key objective is to personalize tacrolimus treatment for children with a renal transplant by using dosing algorithms to calculate both the individual’s tacrolimus starting dose and follow-up doses.
Secondary objectives 1
- Secondary aims are evaluating the role of the gut microbiome in tacrolimus pharmacokinetics, and describing the tacrolimus pharmacokinetics of a once-daily tacrolimus formulation.
Conditions and MedDRA coding
pediatric kidney transplant recipients
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Age 2-18 years old
- Patients to be transplanted with a kidney allograft
- Patients receiving a kidney from a blood group ABO-compatible donor
- Patients who will receive tacrolimus as part of their initial immunosuppressive therapy
- Signed written informed consent.
Exclusion criteria 7
- Recipients of a non-renal organ transplant at the same occasion
- Recipients of a blood group ABO-incompatible kidney allograft
- Recipients of an HLA-incompatible kidney allograft (positive cross-match)
- Recipients receiving tacrolimus as immunosuppressive treatment within the preceding 28 days.
- Recipients using medication known to have a pharmacokinetic (drug-drug) interaction with tacrolimus (see Appendix I, table 1 for specification).
- Extra exclusion criteria for participation in study part B: Children who are not able to swallow a once-daily tacrolimus capsule
- 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 and secondary outcome measures (English text)
Primary endpoints 1
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 8
Envarsus 0.75 mg prolonged-release tablets
PRD1609514 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/14/935/001
- MA holder
- CHIESI FARMACEUTICI S.P.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Envarsus 4 mg prolonged-release tablets
PRD1609569 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/14/935/007
- MA holder
- CHIESI FARMACEUTICI S.P.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Envarsus 1 mg prolonged-release tablets
PRD1609561 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/14/935/004
- MA holder
- CHIESI FARMACEUTICI S.P.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Modigraf 1 mg granules for oral suspension
PRD9548489 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- ORAL SUSPENSION
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/09/523/002
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10226907 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- 8913/2016/02
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- Romania
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Modigraf 0.2 mg granules for oral suspension
PRD9548169 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- ORAL SUSPENSION
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/09/523/001
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10226906 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- 8911/2016/02
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- Romania
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10226711 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- 8912/2016/02
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- Romania
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Sponsor organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Address
- Dr. Molewaterplein 40
- City
- Rotterdam
- Postcode
- 3015 GD
- Country
- Netherlands
Scientific contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Huib de Jong
Public contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Huib de Jong
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 28 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 1 file
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Prograf | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-13 | Netherlands | Acceptable 2024-06-28
|
2024-06-28 |