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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00137345
Recruitment Status : Terminated
First Posted : August 29, 2005
Last Update Posted : February 8, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Kidney Transplant Drug: sirolimus Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2005
Primary Completion Date : August 2006
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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)
  2. Non-inferiority of the composite of graft loss and death at 52 weeks

Secondary Outcome Measures :
  1. 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
  2. quality of life at 24, 52 and 104 weeks

Eligibility Criteria

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137345


  Show 82 Study Locations
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

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 ( Other Identifier: Pfizer )
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: February 8, 2013
Last Verified: September 2006

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:
Cyclosporins
Cyclosporine
Sirolimus
Everolimus
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antineoplastic Agents