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Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance.

NCT ID: NCT00425308

Last Updated: 2017-03-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Brief Summary

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Efficacy and safety of 2 groups of treatment: everolimus in association with cyclosporine microemulsion and steroids versus everolimus in association with Enteric-coated Mycophenolate Sodium (EC-MPS) and steroids. The study population consists of patients having taken part in study CRAD001A2420 (NCT00154297) until the end (12 months) and having not prematurely discontinued the immunosuppressive regimen received in this study (everolimus + cyclosporine microemulsion + steroids).

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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

TREATMENT

Blinding Strategy

NONE

Study Groups

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Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)

Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids

Group Type ACTIVE_COMPARATOR

Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)

Intervention Type DRUG

Steroids

Intervention Type DRUG

Everolimus + Cyclosporine

Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids

Group Type ACTIVE_COMPARATOR

Everolimus + Cyclosporine

Intervention Type DRUG

Steroids

Intervention Type DRUG

Interventions

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Everolimus + Cyclosporine

Intervention Type DRUG

Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)

Intervention Type DRUG

Steroids

Intervention Type DRUG

Other Intervention Names

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Cyclosporine Microemulsion Neoral Myfortic

Eligibility Criteria

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Inclusion Criteria

* Patients who participated in and completed study CRAD001A2420

Exclusion Criteria

* Premature study or study treatment discontinuation in CRAD001A2420 study.
* Acute rejection within the 3 months prior to inclusion
Minimum Eligible Age

18 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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Novartis Pharmaceuticals

Principal Investigators

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Novartis

Role: STUDY_DIRECTOR

Novartis

Locations

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Novartis Investigative Site

Paris, , France

Site Status

Countries

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France

Other Identifiers

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CRAD001AFR06

Identifier Type: -

Identifier Source: org_study_id

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