Status:
UNKNOWN
Pharmacokinetics, Effectiveness and Tolerability of Prolonged-release Tacrolimus After Paediatric Kidney Transplantation
Lead Sponsor:
University Hospital, Essen
Conditions:
Pediatric Kidney Disease
Eligibility:
All Genders
8-18 years
Phase:
PHASE3
Brief Summary
Recently, a new prolonged-release tablet version of tacrolimus (Envarsus®) using the so-called MeltDose™ (US Patent No. 7,217,431) drug-delivery technology has been approved as immunosuppressive medic...
Eligibility Criteria
Inclusion
- caucasian paediatric kidney transplant recipients (single-organ recipients)
- aged ≥ 8 years but ≤ 18 years who are under tacrolimus (Prograf®) therapy and who are able to swallow tablets with a minimum dose of 0.75 mg / day Envarsus®
- not less than 6 months after transplantation
- stable kidney function (delta eGFR \< 10 ml/min/1.73 m2 (CKID formula) over the last 3 months)
- women of childbearing potential and women without childbearing potential
- patient/parents/legal guardian(s) must be capable of understanding purpose and risks of the study
- signed informed consent obtained by patient and parents/legal guardians
Exclusion
- coefficient of variation of tacrolimus trough levels \> 0.35 over the previous 6 months
- pregnancy/breast feeding
- instable kidney function
- hypersensitivity to any of the components of the medications used
- not eligible for any reason according to the investigator's valuation
- known positive HIV-1 or HCV test
- participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)
Key Trial Info
Start Date :
April 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06057545
Start Date
April 25 2023
End Date
March 1 2025
Last Update
September 28 2023
Active Locations (4)
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1
University Hospital Cologne, Pediatrics
Cologne, Germany
2
University Hospital of Essen, Pediatrics II
Essen, Germany
3
University Hospital of Hamburg-Eppendorf
Hamburg, Germany
4
University Hospital of Heidelberg
Heidelberg, Germany