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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
History of Changes
  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:

U.S. FDA Resources

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

No publications provided

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

ClinicalTrials.gov processed this record on May 22, 2013