Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant

NCT ID: NCT00099736

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

696 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-07

Study Completion Date

2005-09-19

Brief Summary

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The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.

Detailed Description

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Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids,

Group Type EXPERIMENTAL

FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids

Intervention Type DRUG

FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids

FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids

Group Type EXPERIMENTAL

FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids

Intervention Type DRUG

FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids

MMF 2 g + full-dose Neoral (FDN) + corticosteroids

Group Type EXPERIMENTAL

MMF 2 g + full-dose Neoral (FDN) + corticosteroids

Intervention Type DRUG

mycophenolate mofetil (MMF) + full-dose Neoral (FDN) + corticosteroids

Interventions

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FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids

FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids

Intervention Type DRUG

FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids

FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids

Intervention Type DRUG

MMF 2 g + full-dose Neoral (FDN) + corticosteroids

mycophenolate mofetil (MMF) + full-dose Neoral (FDN) + corticosteroids

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* First kidney transplantation
* Male and female patients
* Between 18 and 65 years old

Exclusion Criteria

* Patients in need of multiple organ transplants
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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Phoenix, Arizona, United States

Site Status

Los Angeles, California, United States

Site Status

Palo Alto, California, United States

Site Status

San Francisco, California, United States

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Denver, Colorado, United States

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New Haven, Connecticut, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Des Moines, Iowa, United States

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Portland, Maine, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Omaha, Nebraska, United States

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Livingston, New Jersey, United States

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Hawthorne, New York, United States

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Chapel Hill, North Carolina, United States

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Durham, North Carolina, United States

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Cleveland, Ohio, United States

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Cleveland, Ohio, United States

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Toledo, Ohio, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Galveston, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Fairfax, Virginia, United States

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Richmond, Virginia, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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Tedesco-Silva H, Pescovitz MD, Cibrik D, Rees MA, Mulgaonkar S, Kahan BD, Gugliuzza KK, Rajagopalan PR, Esmeraldo Rde M, Lord H, Salvadori M, Slade JM; FTY720 Study Group. Randomized controlled trial of FTY720 versus MMF in de novo renal transplantation. Transplantation. 2006 Dec 27;82(12):1689-97. doi: 10.1097/01.tp.0000251718.95622.b3.

Reference Type DERIVED
PMID: 17198261 (View on PubMed)

Other Identifiers

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CFTY720 0125

Identifier Type: OTHER

Identifier Source: secondary_id

CFTY7200125

Identifier Type: OTHER

Identifier Source: secondary_id

CFTY720A0125

Identifier Type: -

Identifier Source: org_study_id

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