Efficacy, Tolerability and Safety of Early Introduction of Everolimus, Reduced Calcineurin Inhibitors and Early Steroid Elimination Compared to Standard CNI, Mycophenolate Mofetil and Steroid Regimen in Paediatric Renal Transplant Recipients

Inclusion Criteria:

Inclusion criteria at baseline:

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 recipient 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:

1. Patients on TAC + MMF + steroids.

2. Renal function with eGFR > 40 ml/min/1.73 m2 (Schwartz formula - abbreviated).

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 guidelines (Appendix 10 of protocol).

Exclusion criteria at randomization:

1. Use of other investigational drugs at the time of randomization, or within 30 days or
5 half-lives prior randomization, whichever is longer.

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 (Hogg, 2003).