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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
December 14, 2005
December 15, 2005
December 27, 2007
March 2004
Not Provided
Kidney function at 52 weeks after transplantation.
Same as current
Complete list of historical versions of study NCT00266123 on ClinicalTrials.gov Archive Site
Kidney function at 26, 78 and 104 weeks after transplantation
Same as current
Not Provided
Not Provided
 
Study Comparing Two Sirolimus Regimens vs. Tacrolimus and Mycophenolate Mofetil Regimen in Kidney Transplant Recipients
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Graft Rejection
  • Kidney Failure
  • Kidney Transplant
Drug: Sirolimus
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
420
July 2007
Not Provided

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00266123
0468H1-101497
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
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
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP