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
1 other identifier
interventional
420
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2004
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 14, 2005
CompletedFirst Posted
Study publicly available on registry
December 15, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedDecember 27, 2007
December 1, 2007
December 14, 2005
December 18, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Kidney function at 52 weeks after transplantation.
Secondary Outcomes (1)
Kidney function at 26, 78 and 104 weeks after transplantation
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 14, 2005
First Posted
December 15, 2005
Study Start
March 1, 2004
Study Completion
July 1, 2007
Last Updated
December 27, 2007
Record last verified: 2007-12