NCT00098241

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2000

Longer than P75 for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2004

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

6.8 years

First QC Date

December 3, 2004

Last Update Submit

February 21, 2017

Conditions

Kidney Transplantation

Keywords

pediatricrenaltransplant recipientsde novoDe novo renal pediatric transplant

Outcome Measures

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.

Interventions

CerticanDRUG

Eligibility Criteria

Age1 Week - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Columbus Children's Hospital

Columbus, Ohio, 43205-2696, United States

Location

Dienst Pediatrie UZ Gasthuisberg, Herestraat 49

Leuven, 3000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 11583941RESULT

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 3, 2004

First Posted

December 6, 2004

Study Start

June 1, 2000

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

US(1)BE(1)