Julia Grimm

CONTACT

Lead Sponsor

University Hospital, Essen

Age

8 - 18 years

Sex

ALL

Healthy Volunteers

No

•1. caucasian paediatric kidney transplant recipients (single-organ recipients)
•2. 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®
•3. not less than 6 months after transplantation
•4. stable kidney function (delta eGFR \< 10 ml/min/1.73 m2 (CKID formula) over the last 3 months)
•5. women of childbearing potential and women without childbearing potential
•6. patient/parents/legal guardian(s) must be capable of understanding purpose and risks of the study
•7. signed informed consent obtained by patient and parents/legal guardians

•1. coefficient of variation of tacrolimus trough levels \> 0.35 over the previous 6 months
•2. pregnancy/breast feeding
•3. instable kidney function
•4. hypersensitivity to any of the components of the medications used
•6. known positive HIV-1 or HCV test
•7. participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)