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This is a 2-year Follow-up Study to Evaluate the Long-term Effects in Patients Who Completed the Study CRAD001A2307.

NCT ID: NCT00531440

Last Updated: 2011-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Brief Summary

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

Detailed Description

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Conditions

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Renal Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Everolimus (RAD001)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis

Role: STUDY_DIRECTOR

Novartis

Locations

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Novartis

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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CRAD001A2307E1

Identifier Type: -

Identifier Source: org_study_id