The purpose of this study is to evaluate the safety and tolerability of RAD001 (Certican) administered to pediatric renal transplant recipients, and to provide additional safety data.

Condition	Treatment or Intervention	Phase
Kidney Transplantation	Drug: Certican	Phase III

Further Study Details: 

Primary Outcomes: To evaluate the safety & tolerability of RAD given to pediatric de novo renal transplant recipients.

Ages Eligible for Study:  up to  16 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Male and female patients no more than 16 years of age.
• Patients receiving a primary cadaveric or non-HLA identical living donor (related or unrelated) renal transplant.
• The graft must be functional within 48 hours post transplantation.

Exclusion Criteria:

• Cold ischemia time greater than 40 hours.
• Patients who are recipients of multiple solid organ transplants, including dual and en bloc kidneys, or who have previously received transplanted organs.
• Patients with panel reactive T cell antibodies of 50 % or higher at the last assessment before transplantation.

Virginia Moeller, BS, MBA      1-862-778-2484    virginia.moeller@pharma.novartis.com
Jonathan Jaffe, MD      1-862-778-8827    jonathan.jaffe@pharma.novartis.com

Ohio
      Columbus Children's Hospital, Columbus,  Ohio,  43205-2696,  United States; Recruiting
Belgium
      Dienst Pediatrie UZ Gasthuisberg, Herestraat 49, Leuven,  3000,  Belgium; Recruiting

Study ID Numbers:  CRAD001 B351; RAD/Certican
Record last reviewed:  December 2004
Last Updated:  December 3, 2004
Record first received:  December 3, 2004
ClinicalTrials.gov Identifier:  NCT00098241
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08