Status:
COMPLETED
Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Kidney Transplantation
Eligibility:
All Genders
1-16 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2007
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00098241
Start Date
June 1 2000
End Date
March 1 2007
Last Update
February 23 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbus Children's Hospital
Columbus, Ohio, United States, 43205-2696
2
Dienst Pediatrie UZ Gasthuisberg, Herestraat 49
Leuven, Belgium, 3000