Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients
Phase 3
Completed
- Conditions
- Kidney Transplantation
- Registration Number
- NCT00098241
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
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.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety and tolerability at 6 and 12 Months as measured by adverse events, laboratory abnormalities and infections.
- Secondary Outcome Measures
Name Time Method Efficacy at 6 and 12 Months as measured by rejection, graft loss, death and loss to follow up.
Trial Locations
- Locations (2)
Dienst Pediatrie UZ Gasthuisberg, Herestraat 49
🇧🇪Leuven, Belgium
Columbus Children's Hospital
🇺🇸Columbus, Ohio, United States