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CompletedNCT00098241Updated Feb 23, 2017

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

A Phase 3 interventional study of Certican in Kidney Transplantation, sponsored by Novartis Pharmaceuticals. Completed at 2 sites in 2 countries. Open to participants aged 1 Week to 16 Years. Per ClinicalTrials.gov, last updated 2017-02-23.

Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
45
Allocation
Non-randomized
Ages
1 Week to 16 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Kidney Transplantation

Keywords

  • pediatric
  • renal
  • transplant recipients
  • de novo
  • De novo renal pediatric transplant
03

In context

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Week to 16 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Interventions

  • DrugCertican
06

What researchers measure

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.

07

Study locations

2 sites
  • Columbus Children's Hospital
    Columbus, Ohio 43205-2696, United States
  • Dienst Pediatrie UZ Gasthuisberg, Herestraat 49
    Leuven, 3000, Belgium
08

References and documents

Publications

  • Ettenger RB, Grimm EM. Safety and efficacy of TOR inhibitors in pediatric renal transplant recipients. Am J Kidney Dis. 2001 Oct;38(4 Suppl 2):S22-8. doi: 10.1053/ajkd.2001.27838. PubMed 11583941 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00098241
Lead sponsor
Novartis Pharmaceuticals
First posted
Dec 6, 2004
Start date
Jun 2000
Primary completion
Mar 2007
Completion
Mar 2007
Last update
Feb 23, 2017

Study contacts

Novartis
study director · Novartis
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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