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Completed

NCT Number: NCT00098241

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

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.

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Key information

Conditions

Kidney Transplantation

Age range

1 week–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dienst Pediatrie UZ Gasthuisberg, Herestraat 49, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Certican

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2007
Study completion
2007
First posted
Dec 6, 2004
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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