Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant
3 other identifiers
interventional
696
1 country
42
Brief Summary
The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2003
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 7, 2003
CompletedFirst Submitted
Initial submission to the registry
December 17, 2004
CompletedFirst Posted
Study publicly available on registry
December 20, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2005
CompletedAugust 22, 2017
August 1, 2017
2.4 years
December 17, 2004
August 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant
permanent resumption of dialysis within 12 months post transplant
surgical removal of graft within 12 months post transplant
death within 12 months post transplant
withdrawal of consent, death, or lost to follow up within 12 months post transplant
Secondary Outcomes (5)
FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12
serum creatinine
cystatin C at months 3, 6, and 12
proteinuria at day 28, months 6 and 12
absolute lymphocyte count at screening, baseline, day 1, 7, 14, and 28, months 2, 3, 6, 9, and 12
Study Arms (3)
FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids,
EXPERIMENTALFTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
EXPERIMENTALMMF 2 g + full-dose Neoral (FDN) + corticosteroids
EXPERIMENTALInterventions
FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids
FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
mycophenolate mofetil (MMF) + full-dose Neoral (FDN) + corticosteroids
Eligibility Criteria
You may qualify if:
- First kidney transplantation
- Male and female patients
- Between 18 and 65 years old
You may not qualify if:
- Patients in need of multiple organ transplants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Unknown Facility
Phoenix, Arizona, 85054, United States
Unknown Facility
Los Angeles, California, 90057, United States
Unknown Facility
Palo Alto, California, 94303, United States
Unknown Facility
San Francisco, California, 94143, United States
Unknown Facility
Denver, Colorado, 80262, United States
Unknown Facility
New Haven, Connecticut, 06520, United States
Unknown Facility
Tampa, Florida, 33606, United States
Unknown Facility
Atlanta, Georgia, 30309, United States
Unknown Facility
Atlanta, Georgia, 30322, United States
Unknown Facility
Augusta, Georgia, 30912, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Indianapolis, Indiana, 46202, United States
Unknown Facility
Des Moines, Iowa, 50309, United States
Unknown Facility
Portland, Maine, 04102, United States
Unknown Facility
Boston, Massachusetts, 02111, United States
Unknown Facility
Boston, Massachusetts, 02215, United States
Unknown Facility
Ann Arbor, Michigan, 48109, United States
Unknown Facility
Detroit, Michigan, 48202, United States
Unknown Facility
Minneapolis, Minnesota, 55455, United States
Unknown Facility
Rochester, Minnesota, 55905, United States
Unknown Facility
Omaha, Nebraska, 68198, United States
Unknown Facility
Livingston, New Jersey, 07039, United States
Unknown Facility
Hawthorne, New York, 10523, United States
Unknown Facility
Chapel Hill, North Carolina, 27599, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Cleveland, Ohio, 44106, United States
Unknown Facility
Cleveland, Ohio, 44195, United States
Unknown Facility
Toledo, Ohio, 43614, United States
Unknown Facility
Portland, Oregon, 97232, United States
Unknown Facility
Philadelphia, Pennsylvania, 19102, United States
Unknown Facility
Charleston, South Carolina, 29425, United States
Unknown Facility
Memphis, Tennessee, 38103, United States
Unknown Facility
Nashville, Tennessee, 37212, United States
Unknown Facility
Dallas, Texas, 75246, United States
Unknown Facility
Galveston, Texas, 77555, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Salt Lake City, Utah, 84132, United States
Unknown Facility
Fairfax, Virginia, 22042, United States
Unknown Facility
Richmond, Virginia, 23298, United States
Unknown Facility
Madison, Wisconsin, 53792, United States
Unknown Facility
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 17198261DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis
Novartis
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2004
First Posted
December 20, 2004
Study Start
May 7, 2003
Primary Completion
September 19, 2005
Study Completion
September 19, 2005
Last Updated
August 22, 2017
Record last verified: 2017-08