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

Tracking Information
First Submitted Date ICMJE	December 3, 2004
First Posted Date ICMJE	December 6, 2004
Last Update Posted Date	February 23, 2017
Study Start Date ICMJE	June 2000
Actual Primary Completion Date	March 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 23, 2006)	Safety and tolerability at 6 and 12 Months as measured by adverse events, laboratory abnormalities and infections.
Original Primary Outcome Measures ICMJE; (submitted: June 23, 2005)	To evaluate the safety & tolerability of RAD given to pediatric de novo renal transplant recipients.
Change History	Complete list of historical versions of study NCT00098241 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 23, 2006)	Efficacy at 6 and 12 Months as measured by rejection, graft loss, death and loss to follow up.
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients
Official Title ICMJE	Multicenter Trial of the Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients
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 Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Kidney Transplantation
Intervention ICMJE	Drug: Certican
Study Arms	Not Provided
Publications *	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.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: May 23, 2006)	45
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	March 2007
Actual Primary Completion Date	March 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	up to 16 Years (Child)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Belgium, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00098241
Other Study ID Numbers ICMJE	CRAD001AB351; RAD/Certican
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	External Affairs, Novartis Pharmaceuticals
Study Sponsor ICMJE	Novartis Pharmaceuticals
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Novartis Novartis
PRS Account	Novartis
Verification Date	February 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP