Study Comparing Sirolimus With Cyclosporine in a Calcineurin Inhibitor (CNI)-Free Regimen in Kidney Transplant Recipients

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00137345
First received: August 25, 2005
Last updated: February 7, 2013
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Kidney Transplant
Drug: sirolimus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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)
  • Non-inferiority of the composite of graft loss and death at 52 weeks

Secondary Outcome Measures:
  • 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
  • quality of life at 24, 52 and 104 weeks

Estimated Enrollment: 500
Study Start Date: June 2005
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137345

  Hide Study Locations
Locations
United States, California
San Diego, California, United States, 92123
San Francisco, California, United States, 94143
United States, Colorado
Denver, Colorado, United States, 80262
United States, Connecticut
New Haven, Connecticut, United States, 06520
United States, Florida
Gainesville, Florida, United States, 32610
Tampa, Florida, United States, 33606
United States, Georgia
Atlanta, Georgia, United States, 30309
United States, Illinois
Chicago, Illinois, United States, 60612-3824
United States, Maine
Portland, Maine, United States, 04102
United States, Massachusetts
Springfield, Massachusetts, United States, 01199
United States, Michigan
Detroit, Michigan, United States, 48202
United States, New York
New York, New York, United States, 10029
United States, North Carolina
Charlotte, North Carolina, United States, 28203
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland, Ohio, United States, 44106
Cleveland, Ohio, United States, 44195
Toledo, Ohio, United States, 43614
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
Philadelphia, Pennsylvania, United States, 19129
United States, Rhode Island
Providence, Rhode Island, United States
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Dallas, Texas, United States, 75246
Houston, Texas, United States, 77225
Argentina
Buenos Aires, Capital Ferderal, Argentina, C1425APQ
Buenos Aires, Capital Ferderal, Argentina, 1155
Buenos Aires, Capital Ferderal, Argentina, 1093
Buenos Aires, Capital Ferderal, Argentina, C1118AT
Buenos Aires, Capital Ferderal, Argentina, 1425
Buenos Aires, Argentina, CP1900
Ciudad de Bs As, Argentina
Cordoba, Argentina
Cordoba, Argentina, 5000
Australia
Camperdown, Australia, NSW 2050
Parkville, Australia, 3050
Randwick, Australia, 2031
Westmead, Australia, 2145
Woodville South, Australia, SA 5011
Woolloongabba, Australia, QLD 4102
Austria
Wien, Austria, A-1090
Canada, Ontario
London, Ontario, Canada, N6A 5A5
Canada, Quebec
Cote du Palais, Quebec, Canada, G1R 2J6
Montreal, Quebec, Canada, H2L 4M1
Chile
Puente Alto, Chile
Santiago, Chile
Talca, Chile
Vina del Mar, Chile
Cyprus
Nicosia, Cyprus, 1102
France
Montpellier Cedex, France, 34059
Paris Cedex 15, France, 75747
Germany
Munster, Germany, 48149
Greece
Athens, Greece, 11527
Thessaloniki, Greece, 54642
Hungary
Budapest, Hungary, 1083
Debrecen, Hungary, 4012
Pecs, Hungary, 7621
Szeged, Hungary, 6720
Italy
Bari, Italy, 70124
Cagliari, Italy, 09134
Torino, Italy, 10126
Norway
Oslo, Norway, 0027
Portugal
Carnaxide-lisboa, Portugal, 2795-563
Coimbra, Portugal, 3049
Lisboa, Portugal, 81050
Singapore
Singapore, Singapore, 169608
South Africa
Cape Town, South Africa, 7925
Cape Town, South Africa, 8001
Johannesburg, South Africa, 2193
Spain
Barcelona, Spain, 08036
La Coruã'a, Spain, 15006
La Laguna / Santa Cruz de Tenerife, Spain, 38320
Madrid, Spain, 28041
Madrid, Spain, 28040
Santander, Spain, 39008
Valencia, Spain, 46009
Sweden
Uppsala, Sweden, SE-751 85
Taiwan
Taipei, Taiwan, 100
Turkey
Antalya, Turkey, 07070
Istanbul, Turkey, 34390
Izmir, Turkey, 35100
United Kingdom
Glasgow, United Kingdom, G11 6NT
Leicester, United Kingdom, LE5 4PW
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Germany, MedInfoDEU@wyeth.com
Principal Investigator: Trial Manager For Norway, Sweden, MedInfoNord@wyeth.com
Principal Investigator: Trial Manager For Australia, Taiwan, medinfo@wyeth.com
Principal Investigator: Trial Manager For Austria, WPVIMED@wyeth.com
Principal Investigator: Trial Manager For Italy, Greece, decresg@wyeth.com
Principal Investigator: Trial manager For Hungary, WPBUMED@wyeth.com
Principal Investigator: Trial Manager For Turkey, Erisc@wyeth.com
Principal Investigator: Trial Manager For South Africa, ZAFinfo@wyeth.com
Principal Investigator: Trial Manager For Argentina, Chile, scheima@wyeth.com, rendop@wyeth.com
Principal Investigator: Trial Manager For UK, ukmedonfo@wyeth.com
Principal Investigator: Trial Manager For Switzerland, med@wyeth.com
  More Information

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00137345     History of Changes
Other Study ID Numbers: 0468H1-318, B1741188
Study First Received: August 25, 2005
Last Updated: February 7, 2013
Health Authority: European Union: European Medicines Agency
United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Randomized controlled trial
Clinical Trial Phase III
Drug therapy
Immunosuppression
Treatment outcome
Kidney transplantation
Kidney function tests

Additional relevant MeSH terms:
Sirolimus
Cyclosporine
Everolimus
Cyclosporins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 19, 2014