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

Completed · Phase 3

Conditions studied: Kidney Transplantation

In brief

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.

Key facts

Study ID

NCT00098241

Run by

Novartis Pharmaceuticals

People needed

45

Starts

2000-06-01

Expected to finish

2007-03-01

Last updated by the study team

2017-02-23

Who can join

Age: 0 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Columbus Children's Hospital — Columbus, Ohio, United States
• Dienst Pediatrie UZ Gasthuisberg, Herestraat 49 — Leuven, Belgium

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.