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: 19.0 Level: SOC Classification code 10038359 Term: Renal and urinary disorders System Organ Class: 10038359 - Renal and urinary disorders
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2010-024381-21-DE

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 106

Inclusion Criteria

Patients eligible for inclusion in this study have to fulfill all of the following 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 recipient aged 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 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

Patients fulfilling any of the following criteria are not eligible for inclusion in this study at
baseline
1. Recipients of kidneys from donors with known renal disease (such as diabetices
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 halflives
of enrollment, whichever is longer.
4.3. History of hypersensitivity or contraindication to any of the study drugs or to drugs of
similar chemical classes, or to any of the excipients.
5.4. History of malignancy of any organ system treated or untreated, carrying possible risk
of recurrence according to current guidelines (Appendix 10). within the past 5 years,
regardless of whether there is evidence of local recurrence or metastases.
6.5. Pregnant or nursing (lactating) female patients, where pregnancy is defined as the state
of a female after conception and until the termination of gestation, confirmed by a
positive hCG laboratory test (> 9 mIU/mL).
7.6. Female patients of child-bearing potential, defined as all women physiologically
capable of becoming pregnant, UNLESS they agree for to abstinence from sexual activity.
8.7. Patients who are recipients of multiple solid organ transplants, including dual and en
bloc kidneys, or who have previously received transplanted organs except a primary
kidney transplant.
9.8. Recipient of kidneys from HLA-identical living related donors.
This document (090095a8846f511b in docbase CREDI_BS) has been digitally signed with external signatures using Entrust PKI.
Signatures manifested as of 3/4/2013 8:16:30 AM, signing status at this time: Completed (1 of 1 signatures)
Approved for report publication by Martzloff El-Djouher in Basel at Mon, Mar 04, 2013 09:16:13 CET
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Amended Protocol Version v02 track changes Protocol CRAD001A2314
10.9. Recipients of kidneys from donors who are greater than 60 years or younger than 5
years.
11.10. Recipient of ABO incompatible allograft or a positive T cell cross-match.
12.11. Most recent anti-HLA Class I/II panel reactive antibodies > 20 % by a Complement
Dependent Cytotoxicity (CDC)-based assay or > 50% by a flow cytometry or Enzyme
Linked Immunosorbent Assay (ELISA)-based assay.
13.12. Patients considered at high risk of antibody mediated acute rejection (e.g. presence of
pre-formed DSA) (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).
14.13. Patient who is human immunodeficiency virus (HIV) positive or Hepatitis C (PCR
only) or B surface antigen positive. Viral serology

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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