Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients
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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. |
ClinicalTrials.gov Identifier: NCT00098241 |
Recruitment Status
:
Completed
First Posted
: December 6, 2004
Last Update Posted
: February 23, 2017
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Sponsor:
Novartis Pharmaceuticals
Information provided by:
Novartis
Tracking Information | ||||
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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 |
Safety and tolerability at 6 and 12 Months as measured by adverse events, laboratory abnormalities and infections. | |||
Original Primary Outcome Measures ICMJE |
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 |
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 |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |
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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 |