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Study Comparing Two Sirolimus Regimens vs. Tacrolimus and Mycophenolate Mofetil Regimen in Kidney Transplant Recipients

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00266123
First received: December 14, 2005
Last updated: December 18, 2007
Last verified: December 2007
History of Changes
  Purpose

To demonstrate the superiority of SRL + TAC elimination + corticosteroids (Group I) and SRL + MMF + corticosteroids (Group II) to TAC + MMF + corticosteroids (Group III) with respect to renal allograft function at month 12 post-transplantation.


Condition Intervention Phase
Graft Rejection
Kidney Failure
Kidney Transplant
 Drug: Sirolimus
 Phase 4

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 Study to Compare the Safety and Efficacy of Two Different Sirolimus Regimens With a Tacrolimus + Mycophenolate Mofetil Regimen in 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:
  • Kidney function at 52 weeks after transplantation.

Secondary Outcome Measures:
  • Kidney function at 26, 78 and 104 weeks after transplantation

Estimated Enrollment: 420
Study Start Date: March 2004
Study Completion Date: July 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years.
  • End-stage renal disease with subjects scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated mismatched donor, or from a living-related mismatched donor. Unreported HLA values will be considered a match.
  • Women of childbearing potential must have a negative serum pregnancy test before administration of assigned treatment and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment.

Other inclusions apply.

Exclusion Criteria:

  • Evidence of active systemic or localized major infection.
  • Known hypersensitivity to SRL or its derivatives, macrolide antibiotics, corticosteroids, TAC or MMF.
  • Multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant).

Other exclusions apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00266123

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth Reseach
Principal Investigator: Trial Manager For Belgium, trials-BEL@wyeth.com
Principal Investigator: Trial Manager For France, infomedfrance@wyeth.com
Principal Investigator: Trial Manager For Germany, MedinfoDEU@wyeth.com
Principal Investigator: Trial Manager For Italy, decresg@wyeth.com
Principal Investigator: Trial Manager For Poland, WPWZMED@wyeth.com
Principal Investigator: Trial Manager For Spain, infomed@wyeth.com
Principal Investigator: Trial Manager For Switzerland, med@wyeth.com
Principal Investigator: Trial Manager For United Kingdom, ukmedinfo@wyeth.com
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00266123     History of Changes
Other Study ID Numbers: 0468H1-101497
Study First Received: December 14, 2005
Last Updated: December 18, 2007
Health Authority: Belgium: Institutional Review Board

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Kidney Failure
Kidney Transplant

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Mycophenolate mofetil
Sirolimus
Everolimus
Tacrolimus
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on June 18, 2013