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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00098241
First Posted: December 6, 2004
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
December 3, 2004
December 6, 2004
February 23, 2017
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Kidney Transplantation
Drug: Certican
Not Provided
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.

*   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.
Sexes Eligible for Study: All
up to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   United States
 
 
NCT00098241
CRAD001AB351
RAD/Certican
Not Provided
Not Provided
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Novartis
Novartis
February 2017

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