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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:
ClinicalTrials.gov Identifier:
NCT00266123
First Posted: December 15, 2005
Last Update Posted: December 27, 2007
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.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): 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

ClinicalTrials.gov Identifier: NCT00266123     History of Changes
Other Study ID Numbers: 0468H1-101497
First Submitted: December 14, 2005
First Posted: December 15, 2005
Last Update Posted: December 27, 2007
Last Verified: December 2007

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
Tacrolimus
Sirolimus
Everolimus
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Antibiotics, Antitubercular
Antitubercular Agents