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Safety, Tolerability and Efficacy of Everolimus With Lower Versus Higher Levels of Tacrolimus in de Novo Renal Transplant Patients

NCT ID: NCT00170833

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Brief Summary

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This study will assess the safety and efficacy of everolimus with basiliximab, corticosteroids and lower levels versus higher levels of tacrolimus in de novo renal transplant recipients.

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female patients between 18 and 65 years of age
* Male or female patients who are primary cadaveric, living unrelated or non-HLA identical living related donor renal transplant recipients
* The renal cold ischemic time (CIT) must be \< 30 hours
* The age of the donor must be between 10 and 59 years and not meet UNOS expanded donor criteria

Exclusion Criteria

* Patients meeting any of the following criteria at baseline will be excluded from study participation.
* Patients who have previously received an organ transplant
* Patients who are recipients of a multiple organ transplants
* Recipients of non heart-beating donor organs
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

References

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Chan L, Greenstein S, Hardy MA, Hartmann E, Bunnapradist S, Cibrik D, Shaw LM, Munir L, Ulbricht B, Cooper M; CRADUS09 Study Group. Multicenter, randomized study of the use of everolimus with tacrolimus after renal transplantation demonstrates its effectiveness. Transplantation. 2008 Mar 27;85(6):821-6. doi: 10.1097/TP.0b013e318166927b.

Reference Type DERIVED
PMID: 18360262 (View on PubMed)

Other Identifiers

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CRAD001AUS09

Identifier Type: -

Identifier Source: org_study_id