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

To estimate the rate of the composite efficacy endpoint of biopsy-proven acute rejection (BPAR), graft loss or death at 12 months post transplantation in primary paediatric kidney transplant recipients converted at 4-6 weeks post-transplantation from MMF + standard TAC regimen and steroids, to everolimus + reduced dose TAC regimen and steroid withdrawal at 6 months, versus continuation of MMF + standard TAC regimen and steroids.

Time frame: 12 months, 36 months

Population: Full Analysis set (12 months and 36 months) Results given as number of participants with composite efficacy failures

To evaluate renal function assessed by Glomerular Filtration Rate (eGFR) estimated by the Schwartz Formula (abbreviated) (Schwartz, 2009).

Time frame: 12 months and 36 months post-transplantation

Population: Full Analysis set 12 months and 36 months

To evaluate the proportion of patients with chronic allograft nephropathy (interstitial fibrosis and tubular atrophy, IF/TA) by histopathology and its progression.The term chronic allograft nephropathy was used inappropriately in the protocol and therefore, replaced by interstitial fibrosis and tubular atrophy

Time frame: at 12 and 36 months post-transplantation.

To evaluate the proportion of patients with the following efficacy events: Biopsy Proven Acute Rejection (BPAR), graft loss or death. The efficacy events will be descriptively summarized by treatment group.

Time frame: at 12 and 36 months post-transplantation

Population: full Analysis set 36 month analysis Results given as number of participants with composite efficacy failures

results given as eGFR values by time interval

Time frame: baseline, 6 months, 12 months , 24 months, 36 months

Population: full Analysis set 36 months

Evaluation of the potential effects upon the bone growth. The Z-score is a statistical tool which helps to assess data (here child growth parameters) relative to a reference or standard population. The Z-score describes the distance and direction of an observation away from the population median (or mean, however, here the median was used). A negative Z-score shows that data are lower than the median of the standard population, a positive Z-score shows that data are higher than the median of the standard population, and a Z-score of zero shows that the data are equal to the median of the standard population. The more the Z-score is distant from 0, the more expressed is for example underweight or overweight.

Time frame: month 12 , month 36 post transplantation.

Population: safety set, 36 months analysis

To evaluate the proportion of patients with the following efficacy events: biopsy proven antibody mediated rejection/Steroid resistant BPAR and BPAR treated with T cell depleting therapy.

Time frame: at 12 and 36 months post-transplantation

Population: Full Analysis set

The urinary protein/creatinine ratio will be descriptively summarized by treatment group at each visit. The incidence rate of patients with proteinuria will be categorized in \<0.2 g/mg/mg, 0.2\<2.0 mg/mg and ≥ 2.0 mg/mg and summarized by treatment groups at each visit.

Time frame: at 12 and 36 months post-transplantation

Population: full analysis set 36 months analysis

To evaluate renal function assessed by Glomerular Filtration Rate (eGFR) estimated by the Schwartz Formula (extended) (Schwartz, 2009). Results given as change from randomization

Time frame: 12 months post-transplantation

Population: Full Analysis set 12 months months

T-cell mediated rejection severity : Type IA - Significant interstitial infiltration (\> 25% of parenchyma) and foci of moderate tubulitis (\> 4 mononuclear cells/tubular cross section or group of 10 tubular cells). Type IB - Significant interstitial infiltration (\> 25% of parenchyma) and foci of severe tubulitis (\> 10 mononuclear cells/tubular cross section or group of 10 tubular cells). Type IIA - Mild to moderate intimal arteritis Type IIB - Severe intimal arteritis comprising \> 25% of the lumenal area Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)

Time frame: month 12, month 36

Population: full Analysis set 36 months

Time to incidence of Event, given in terms of number of participants with an Event according to time interval up to 36 months

Time frame: 36 months

Population: full Analysis set, 36 month analysis