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.

Phase 1

Conditions: Prevention of acute rejection in paediatric recipients of a renal transplant
MedDRA version: 16.0Level: SOCClassification code 10038359Term: Renal and urinary disordersSystem Organ Class: 10038359 - Renal and urinary disorders
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2010-024381-21-ES

Lead Sponsor: ovartis Farmacéutica, S.A.

Brief Summary: Not available

Detailed Description: Not available

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 (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 - 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 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).
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