Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant
NCT ID: NCT00099736
Last Updated: 2017-08-22
Study Results
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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COMPLETED
PHASE3
696 participants
INTERVENTIONAL
2003-05-07
2005-09-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids,
FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids
FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids
FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
MMF 2 g + full-dose Neoral (FDN) + corticosteroids
MMF 2 g + full-dose Neoral (FDN) + corticosteroids
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
FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
MMF 2 g + full-dose Neoral (FDN) + corticosteroids
mycophenolate mofetil (MMF) + full-dose Neoral (FDN) + corticosteroids
Eligibility Criteria
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Inclusion Criteria
* Male and female patients
* Between 18 and 65 years old
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis
Role: STUDY_DIRECTOR
Novartis
Locations
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Phoenix, Arizona, United States
Los Angeles, California, United States
Palo Alto, California, United States
San Francisco, California, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Des Moines, Iowa, United States
Portland, Maine, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
Omaha, Nebraska, United States
Livingston, New Jersey, United States
Hawthorne, New York, United States
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Toledo, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Galveston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Fairfax, Virginia, United States
Richmond, Virginia, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Countries
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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.
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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