Efficacy and Safety of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen

NCT ID: NCT00170820

Last Updated: 2017-02-27

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

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Brief Summary

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The purpose of this study is to assess if a combination of everolimus, steroids, and mycophenolate mofetil is associated with a better renal function than sirolimus.

Detailed Description

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Conditions

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Renal Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Everolimus

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* First or second renal transplantation (1 to 10 years post-transplant)
* Treatment with sirolimus + mycophenolate mofetil + steroids + ACE inhibitor or angiotensin II receptor antagonist + statin

Exclusion Criteria

* Treatment with a CNI or azathioprine
* Vascular rejection or biopsy-proven acute rejection within 3 months prior to screening
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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

References

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Kamar N, Jaafar A, Esposito L, Ribes D, Durand D, Di-Giambattista F, Tack I, Rostaing L. Conversion from sirolimus to everolimus in maintenance renal transplant recipients within a calcineurin inhibitor-free regimen: results of a 6-month pilot study. Clin Nephrol. 2008 Aug;70(2):118-25. doi: 10.5414/cnp70118.

Reference Type RESULT
PMID: 18793527 (View on PubMed)

Other Identifiers

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CRAD001AFR04

Identifier Type: -

Identifier Source: org_study_id

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