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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: February 21, 2017
Last verified: February 2017
  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
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

Resource links provided by NLM:


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   (Child)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
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: February 21, 2017

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

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

ClinicalTrials.gov processed this record on August 18, 2017