Clinical trial NCT00137345: Study Comparing Sirolimus With Cyclosporine in a Calcineurin Inhibitor (CNI)-Free Regimen in Kidney Transplant Recipients
Official title: A Randomized, Open-Label, Comparative Evaluation of the Safety and Efficacy of Sirolimus Versus Cyclosporine When Combined in a Regimen Containing Basiliximab, Mycophenolate Mofetil, and Corticosteroids in Primary De Novo Renal Allograft Recipients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Kidney Transplant
Keywords: Randomized controlled trial
Clinical Trial Phase III
Drug therapy
Immunosuppression
Treatment outcome
Kidney transplantation
Kidney function tests
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-29
Enrollment: 500
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if one drug is superior to another with regard to safety and the preservation of renal function after a kidney transplant.


Eligibility criteria: Inclusion Criteria:

* Dialysis patients who will be receiving their first kidney transplant
* Weight over 88 pounds (lbs.)

Exclusion Criteria:

* Very high cholesterol levels
* Obesity
* Organ donor over 65 years of age if living; over 60 years of age if cadaveric.

Primary outcomes:
measure: To demonstrate the superiority of the sirolimus regimen versus cyclosporin A by intent to treat analysis of kidney function at 52 weeks, measured by mean glomerular filtration rate (GFR)
measure: Non-inferiority of the composite of graft loss and death at 52 weeks
Secondary outcomes:
measure: Incidence and severity of rejection at 12, 24, 52, 104, 156, 208 weeks; GFR at 24, 104, 156, 208 weeks; progression of chronic allograft nephropathy or deterioration of transplanted kidney at 52 weeks
measure: quality of life at 24, 52 and 104 weeks
Other outcomes:
Locations:
city: San Diego
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: Gainesville
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Portland
country: United States
state: Maine
city: Springfield
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: New York
country: United States
state: New York
city: Charlotte
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: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Charleston
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Buenos Aires
country: Argentina
state: Capital Ferderal
city: Buenos Aires
country: Argentina
state: Capital Ferderal
city: Buenos Aires
country: Argentina
state: Capital Ferderal
city: Buenos Aires
country: Argentina
state: Capital Ferderal
city: Buenos Aires
country: Argentina
state: Capital Ferderal
city: Buenos Aires
country: Argentina
city: Ciudad de Bs As
country: Argentina
city: Cordoba
country: Argentina
city: Cordoba
country: Argentina
city: Camperdown
country: Australia
city: Parkville
country: Australia
city: Randwick
country: Australia
city: Westmead
country: Australia
city: Woodville South
country: Australia
city: Woolloongabba
country: Australia
city: Wien
country: Austria
city: London
country: Canada
state: Ontario
city: Cote du Palais
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Puente Alto
country: Chile
city: Santiago
country: Chile
city: Talca
country: Chile
city: Vina del Mar
country: Chile
city: Nicosia
country: Cyprus
city: Montpellier Cedex
country: France
city: Paris Cedex 15
country: France
city: Munster
country: Germany
city: Athens
country: Greece
city: Thessaloniki
country: Greece
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Pecs
country: Hungary
city: Szeged
country: Hungary
city: Bari
country: Italy
city: Cagliari
country: Italy
city: Torino
country: Italy
city: Oslo
country: Norway
city: Carnaxide-lisboa
country: Portugal
city: Coimbra
country: Portugal
city: Lisboa
country: Portugal
city: Singapore
country: Singapore
city: Cape Town
country: South Africa
city: Cape Town
country: South Africa
city: Johannesburg
country: South Africa
city: Barcelona
country: Spain
city: La Coruã'a
country: Spain
city: La Laguna / Santa Cruz de Tenerife
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Santander
country: Spain
city: Valencia
country: Spain
city: Uppsala
country: Sweden
city: Taipei
country: Taiwan
city: Antalya
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Glasgow
country: United Kingdom
city: Leicester
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Germany, MedInfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Norway, Sweden, MedInfoNord@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Australia, Taiwan, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Austria, WPVIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Italy, Greece, decresg@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Hungary, WPBUMED@wyeth.com
name: Trial manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Turkey, Erisc@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For South Africa, ZAFinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Argentina, Chile, scheima@wyeth.com, rendop@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For UK, ukmedonfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Switzerland, med@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flechner SM, Gurkan A, Hartmann A, Legendre CM, Russ GR, Campistol JM, Schena FP, Hahn CM, Li H, Korth-Bradley JM, Tai SS, Schulman SL. A randomized, open-label study of sirolimus versus cyclosporine in primary de novo renal allograft recipients. Transplantation. 2013 May 27;95(10):1233-41. doi: 10.1097/TP.0b013e318291a269.