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Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients

NCT ID: NCT00239785

Last Updated: 2017-08-22

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

684 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Brief Summary

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This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney organ transplant

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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

DOUBLE

Interventions

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FTY720

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female patients of any race between 18 to 65 years old (inclusive)
* Patients scheduled to undergo a primary cadaveric or primary non-HLA identical living donor kidney transplantation

Exclusion Criteria

* Recipients of multi-organ transplantation or foreseen to receive a non-renal allograft during the study period
* Graft cold ischemia time greater than 40 hours.
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

Other Identifiers

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CFTY720A0124

Identifier Type: -

Identifier Source: org_study_id

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