Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00098241
First received: December 3, 2004
Last updated: June 15, 2011
Last verified: June 2011

December 3, 2004
June 15, 2011
June 2000
March 2007   (final data collection date for primary outcome measure)
Safety and tolerability at 6 and 12 Months as measured by adverse events, laboratory abnormalities and infections.
To evaluate the safety & tolerability of RAD given to pediatric de novo renal transplant recipients.
Complete list of historical versions of study NCT00098241 on ClinicalTrials.gov Archive Site
Efficacy at 6 and 12 Months as measured by rejection, graft loss, death and loss to follow up.
Not Provided
Not Provided
Not Provided
 
Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients
Multicenter Trial of the Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Transplantation
Drug: Certican
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
March 2007
March 2007   (final data collection date for primary outcome measure)

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.
Both
up to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium
 
NCT00098241
CRAD001AB351, RAD/Certican
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Novartis
Novartis
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP