A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients
A Randomized, Open-label and Multicenter Trial Comparing Withdrawal of Steroids or Tacrolimus From Sirolimus-based Immunosuppressive Regimen in de Novo Renal Allograft Recipients
1 other identifier
interventional
47
1 country
1
Brief Summary
This study evaluates two different immunosuppression drug regimens in patients with a recent kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and Prednisone and then randomized to discontinue either Tacrolimus or Prednisone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2005
Typical duration for phase_4
1 active site
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
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedResults Posted
Study results publicly available
June 2, 2009
CompletedDecember 11, 2023
April 1, 2010
September 12, 2005
December 19, 2008
December 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.
Diagnosis of acute rejection was made via kidney biopsy using the Banff criteria (a standardized model for interpretation of renal allograft biopsies).
12 months
Secondary Outcomes (1)
Creatinine Clearance Rate
12 months
Study Arms (2)
Sirolimus + Tacrolimus
EXPERIMENTALSirolimus + Prednisone
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- End-stage renal disease, with patients scheduled to receive a kidney transplant.
- Women who are of childbearing potential who are not pregnant and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of study drugs. Any woman becoming pregnant during the treatment period must discontinue the use of study drugs;
- Signed informed consent.
You may not qualify if:
- Evidence of active systemic or localized major infection at the time of initial study drug administration;
- Multiple organ transplants;
- Any pathology or medical condition that can interfere with this protocol study proposal.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- U. S. Contact Center
- Organization
- Wyeth
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
- PRINCIPAL INVESTIGATOR
Trial Manager
For Brazil, xavierl@wyeth.com
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
August 1, 2005
Study Completion
October 1, 2007
Last Updated
December 11, 2023
Results First Posted
June 2, 2009
Record last verified: 2010-04