Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients
NCT ID: NCT00129961
Last Updated: 2012-04-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
86 participants
INTERVENTIONAL
2005-08-31
2009-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients
NCT00038948
Study Comparing Two Sirolimus Regimens vs. Tacrolimus and Mycophenolate Mofetil Regimen in Kidney Transplant Recipients
NCT00266123
Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol
NCT01797315
Study Evaluating the Efficacy and Safety of Cyclosporine Reduction in Kidney Transplant Recipients Receiving Sirolimus
NCT00507793
Study Comparing Sirolimus With Cyclosporine in a Calcineurin Inhibitor (CNI)-Free Regimen in Kidney Transplant Recipients
NCT00137345
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Conversion to a sirolimus-based regimen
sirolimus
2
Continuation of a CNI-based regimen
cyclosporine or tacrolimus
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
sirolimus
cyclosporine or tacrolimus
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects with a functioning renal allograft with calculated glomerular filtration rate (GFR) ≥40mL/min (Nankivell method) and proteinuria ≤500mg/day.
* Stable on cyclosporine or tacrolimus-based multi-drug immunosuppressive regimen
* History of NMSC within last 3 years
Exclusion Criteria
* NMSC with metastatic disease or more than 20 NMSC lesions in last 12 months
* Multiple organ transplant
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
San Diego, California, United States
San Francisco, California, United States
Gainesville, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Nashville, Tennessee, United States
Madison, Wisconsin, United States
Camperdown, New South Wales, Australia
Wooloongabba, Queensland, Australia
Woodville, South Australia, Australia
Adelaide, , Australia
Clayton, , Australia
Herston, , Australia
Parkville, , Australia
Randwick, , Australia
Westmead, , Australia
Vancouver, British Columbia, Canada
Grafton, Auckland, New Zealand
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Campbell SB, Walker R, Tai SS, Jiang Q, Russ GR. Randomized controlled trial of sirolimus for renal transplant recipients at high risk for nonmelanoma skin cancer. Am J Transplant. 2012 May;12(5):1146-56. doi: 10.1111/j.1600-6143.2012.04004.x. Epub 2012 Mar 15.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0468H1-407
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.