NCT00531440

Brief Summary

This extension study is designed to provide long-term safety and efficacy data beyond 12 months up to Month 36.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
256

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

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

November 1, 2001

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2007

Completed
Last Updated

November 2, 2011

Status Verified

November 1, 2011

Enrollment Period

3.8 years

First QC Date

September 17, 2007

Last Update Submit

November 1, 2011

Conditions

Renal Transplantation

Keywords

Renal transplantation, everolimus, Immunosuppressants

Outcome Measures

Primary Outcomes (1)

  • graft loss, death, biopsy-proven acute rejection,antibody-treated ,biopsy-proven chronic allograft nephropathy,retransplantation/dialysis up to 36m renal function measured by creatinine clearance Cockcroft-Gault)calculated glomerularfiltration rate

Secondary Outcomes (1)

  • biopsy-proven acute rejection episodes,graft loss, deathor lost to follow-up 6,12,24&3677 Mths both groups.assess the incidence of graft loss, death, biopsy-proven acute rejection, antibody-treated acute rejection, clinically-confirmed acute rejection.

Interventions

Everolimus (RAD001)DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are receiving study medication at Month 12 (CRAD001A2307) and sign a new Informed Consent to extend the treatment or observation period beyond Month 12.
  • Female patients must agree to continue using an approved method of birth control throughout the study and for 3 months following the last dose of study medication.
  • Another Informed Consent was required for the extension amendment. This Informed Consent allowed for separate consent to the amendment study itself, and the retrospective collection of biopsies and/or the yearly protocol biopsies.

You may not qualify if:

  • Patients who are receiving study medication and do not sign a new Informed Consent to extend the treatment and observation period beyond Month 12 cannot enter the extension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Basel, Switzerland

Location

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2007

First Posted

September 18, 2007

Study Start

November 1, 2001

Primary Completion

August 1, 2005

Last Updated

November 2, 2011

Record last verified: 2011-11

Locations

CH(1)