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
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 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:
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 April 14, 2014