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 paediatric kidney transplant greater than or equal to 1 year and younger than 18 years receiving a primary 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 > 50 ml/min/1.73 m2.
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 - Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
4 - History of hypersensitivity or contraindications to any of the study drugs or to drugs of similar chemical classes, or to any of the excipients.
5 - History of malignancy of any organ system treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.

other protocol-defined exclusion criteria may apply

Exclusion criteria at Randomization (4-6 weeks after transplantation)
1 - Patients with ongoing or currently treated episodes of acute rejection (any grade) or a steroid resistant acute rejection at the time of randomization.
2 - Patients who experienced acute cellular rejection (Banff =1B) or any antibody mediated acute rejection at any time before randomization.
3 - Patients with ongoing wound healing problems, clinically significant wound infection requiring continued therapy or other severe surgical complication in the opinion of the investigator.
4 - 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).
5 - Patients with nephrotic range proteinuria (protein to creatinine ratio =2.0 mg/mg or 200 mg/mmol.

other protocol-defined exclusion criteria may apply