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

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
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: Certican Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Trial of the Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients
Study Start Date : June 2000
Primary Completion Date : March 2007
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00098241

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

Additional Information:
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00098241     History of Changes
Other Study ID Numbers: CRAD001AB351
First Posted: December 6, 2004    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

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

Additional relevant MeSH terms:
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents