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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00266123 |
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Date of registration:
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14/12/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study Comparing Two Sirolimus Regimens vs. Tacrolimus and Mycophenolate Mofetil Regimen in Kidney Transplant Recipients
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Scientific title:
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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 |
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Date of first enrolment:
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March 2004 |
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Target sample size:
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420 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00266123 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Contacts
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Spain, infomed@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Italy, decresg@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Poland, WPWZMED@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For United Kingdom, ukmedinfo@wyeth.com |
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth Reseach |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Germany, MedinfoDEU@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Belgium, trials-BEL@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For France, infomedfrance@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Switzerland, med@wyeth.com |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Graft Rejection
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Kidney Failure
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Kidney Transplant
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Intervention(s)
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Drug: Sirolimus
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Primary Outcome(s)
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Kidney function at 52 weeks after transplantation.
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Secondary Outcome(s)
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Kidney function at 26, 78 and 104 weeks after transplantation
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Secondary ID(s)
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0468H1-101497
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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