Safety & Efficacy of Certican in Pediatric de Novo Renal... | NCT00098241

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

NCT00098241

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Feb 23, 2017Actual

Enrollment

45Estimated

Phase

Phase 3

Conditions

Kidney Transplantation

Interventions

Certican

Countries

United States
Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
RAD/Certican

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2000

Primary Completion Date

Mar 2007Actual

Completion Date

Mar 2007Actual

First Submitted Date

Dec 3, 2004

First Submission Date that Met QC Criteria

Dec 3, 2004

First Posted Date

Dec 6, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2017

Last Update Posted Date

Feb 23, 2017Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Name	Type	Description	Arm Group Labels	Other Names
Certican	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability at 6 and 12 Months as measured by adverse events, laboratory abnormalities and infections.

Secondary Outcomes

Measure	Description	Time Frame
Efficacy at 6 and 12 Months as measured by rejection, graft loss, death and loss to follow up.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Week

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis	Novartis	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Columbus Children's Hospital		Columbus	Ohio	43205-2696	United States
Dienst Pediatrie UZ Gasthuisberg, Herestraat 49

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11583941	Result	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.

ID	Term
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals