Kidney Transplantation Clinical Trial
Official title:
Multicenter Trial of the Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients
Verified date | February 2017 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | March 2007 |
Est. primary completion date | March 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 16 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Dienst Pediatrie UZ Gasthuisberg, Herestraat 49 | Leuven | |
United States | Columbus Children's Hospital | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Belgium,
Ettenger RB, Grimm EM. Safety and efficacy of TOR inhibitors in pediatric renal transplant recipients. Am J Kidney Dis. 2001 Oct;38(4 Suppl 2):S22-8. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability at 6 and 12 Months as measured by adverse events, laboratory abnormalities and infections. | |||
Secondary | Efficacy at 6 and 12 Months as measured by rejection, graft loss, death and loss to follow up. |
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