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: February 21, 2017

Last verified: February 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

December 3, 2004

Last Updated Date

February 21, 2017

Start Date ^ICMJE

June 2000

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

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

Completion Date

March 2007

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

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

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

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