Pediatric patients that received a transplanted kidney will receive immunosuppressive medication-the calcineurin inhibitor (tacrolimus) and antiproliferative agent (MMF)-until they will be randomized between week 4 and 6 to receive either the same treatment or to switch to the investigational drug everolimus. The patients will be followed up until 3 years after transplantation to evaluate the efficacy, tolerability and safety of the treatments and to assess their impact on renal function.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 106

Inclusion Criteria

Inclusion criteria at baseline (transplantation)
1-Written informed consent/assent must be obtained from the parent(s) or legal guardian before any assessment is performed.
2- Primary or secondary paediatric kidney transplant recepient aged greater than or equal to 1 year and younger than 18 years receiving a deceased donor or non-HLA identical living donor (related or unrelated) renal transplant.

Inclusion criteria at randomization (4-6 weeks after transplantation)
1-Patients on TAC + MMF + steroids.
2- Renal function with eGFR > 40 ml/min/1.73 m2 (Schwartz formula-abbreviated).
Are the trial subjects under 18? yes
Number of subjects for this age range: 106
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

exclusion criteria at baseline:
1- Recipients of kidneys from donors with known renal disease (such as diabetes nephropathy, nephrosclerosis), at the time of transplant.
2 - Recipients of a kidney with a cold ischemia time > 24 hours.
3 - History of hypersensitivity or contraindications to any of the study drugs or to drugs of similar chemical classes, or to any of the excipients.
4 - History of malignancy of any organ system treated or untreated, carrying possible risk of recurrence according to current guideline (Appedix 10).

other protocol-defined exclusion criteria may apply

Exclusion criteria at Randomization (4-6 weeks after transplantation)
1 - Use of other investigational drugs at the time of randomization, or within 30 days or 5 half-lives prior randomization, whichever is logest.
2-Patients with ongoing or recently (within 2 weeks prior to randomization) treated episodes of acute rejection (any grade) or a steroid resistant acute rejection at the time of randomization.
3 - Patients who experienced acute cellular rejection (Banff =1B) or any antibody mediated acute rejection or patients considered at high risk of antibody mediated acute rejection by the investigator assessment (e.g. presence of newly formed DSA, histological suspicion) at any time before randomization (as the DSA quantitative threshold to define high risk is not fully established, the assessment of the risk will be made after discussion between the laboratory expert and the investigator who will take into account all information available and apply best judgment).
4 - Patients with ongoing wound healing problems, clinically significant wound infection requiring continued therapy or other severe surgical complication in the opinion of the investigator.
5 - Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) and can not discontinue the treatment (see Appendix 6 for list of medications).
6 - Patients with nephrotic range proteinuria (protein to creatinine ratio =2.0 mg/mg or 200 mg/mmol.

other protocol-defined exclusion criteria may apply

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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