Kidney Transplantation
Conditions
Keywords
pediatric, renal, transplant recipients, de novo, De novo renal pediatric transplant
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.
Interventions
DRUGCertican
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability at 6 and 12 Months as measured by adverse events, laboratory abnormalities and infections. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy at 6 and 12 Months as measured by rejection, graft loss, death and loss to follow up. | — |
Countries
Belgium, United States
Outcome results
None listed