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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation
 Drug: Certican
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Trial of the Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety and tolerability at 6 and 12 Months as measured by adverse events, laboratory abnormalities and infections.

Secondary Outcome Measures:
  • Efficacy at 6 and 12 Months as measured by rejection, graft loss, death and loss to follow up.

Estimated Enrollment: 45
Study Start Date: June 2000
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00098241

Locations
United States, Ohio
Columbus Children's Hospital
Columbus, Ohio, United States, 43205-2696
Belgium
Dienst Pediatrie UZ Gasthuisberg, Herestraat 49
Leuven, Belgium, 3000
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00098241     History of Changes
Other Study ID Numbers: CRAD001AB351, RAD/Certican
Study First Received: December 3, 2004
Last Updated: June 15, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
pediatric
renal
transplant recipients
de novo
De novo renal pediatric transplant

Additional relevant MeSH terms:
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 16, 2013