Clinical trial NCT00099736: Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant
Official title: Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplantation
Keywords: Kidney, transplantation, rejection, immunosuppression
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-20
Enrollment: 696
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients in need of multiple organ transplants

Primary outcomes:
measure: IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant
measure: permanent resumption of dialysis within 12 months post transplant
measure: surgical removal of graft within 12 months post transplant
measure: death within 12 months post transplant
measure: withdrawal of consent, death, or lost to follow up within 12 months post transplant
Secondary outcomes:
measure: FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12
measure: serum creatinine
measure: cystatin C at months 3, 6, and 12
measure: proteinuria at day 28, months 6 and 12
measure: absolute lymphocyte count at screening, baseline, day 1, 7, 14, and 28, months 2, 3, 6, 9, and 12
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Portland
country: United States
state: Maine
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Rochester
country: United States
state: Minnesota
city: Omaha
country: United States
state: Nebraska
city: Livingston
country: United States
state: New Jersey
city: Hawthorne
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Fairfax
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: 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.