A Study to Compare Early Steroid Withdrawal and Long-Term Steroid Maintenance Therapy in Kidney Transplant Patients
NCT ID: NCT00650468
Last Updated: 2011-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
397 participants
INTERVENTIONAL
1999-11-30
2007-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
early steroid cessation
tacrolimus
Oral
CellCept
IV or Oral
steroids (methylprednisone or prednisone)
IV or Oral
2
long-term maintenance steroids
tacrolimus
Oral
CellCept
IV or Oral
steroids (methylprednisone or prednisone)
IV or Oral
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
tacrolimus
Oral
CellCept
IV or Oral
steroids (methylprednisone or prednisone)
IV or Oral
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion:
* Patient is receiving kidney from HLA identical,living donor
* Patient is a multi-organ transplant recipient
* Patient is pregnant or lactating. Female patients of child bering potential must have a negative pregnancy test and agree to practice effective birth control
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Astellas Pharma Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Astellas Pharma US, Inc
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
central contact
Role: STUDY_DIRECTOR
Astellas Pharma US, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Little Rock, Arkansas, United States
Loma Linda, California, United States
Los Angeles, California, United States
Denver, Colorado, United States
Chicago, Illinois, United States
Lexington, Kentucky, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
Omaha, Nebraska, United States
New Brunswick, New Jersey, United States
Buffalo, New York, United States
New York, New York, United States
New York, New York, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Providence, Rhode Island, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Galveston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
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.
Woodle ES; Fujisawa Corticosteroid Withdrawal Study Group. A prospective, randomized, multicenter, double-blind study of early corticosteroid cessation versus long-term maintenance of corticosteroid therapy with tacrolimus and mycophenolate mofetil in primary renal transplant recipients: one year report. Transplant Proc. 2005 Mar;37(2):804-8. doi: 10.1016/j.transproceed.2004.12.083.
Woodle ES, First MR, Pirsch J, Shihab F, Gaber AO, Van Veldhuisen P; Astellas Corticosteroid Withdrawal Study Group. A prospective, randomized, double-blind, placebo-controlled multicenter trial comparing early (7 day) corticosteroid cessation versus long-term, low-dose corticosteroid therapy. Ann Surg. 2008 Oct;248(4):564-77. doi: 10.1097/SLA.0b013e318187d1da.
Gaber AO, Moore LW, Alloway RR, Woodle ES, Pirsch J, Shihab F, Henning A, Fitzsimmons W, Holman J, Reisfield R, First MR; Astellas Corticosteroid Withdrawal Study Group. Acute rejection characteristics from a prospective, randomized, double-blind, placebo-controlled multicenter trial of early corticosteroid withdrawal. Transplantation. 2013 Feb 27;95(4):573-9. doi: 10.1097/TP.0b013e3182777efb.
Delgado JC, Fuller A, Ozawa M, Smith L, Terasaki PI, Shihab FS, Eckels DD. No occurrence of de novo HLA antibodies in patients with early corticosteroid withdrawal in a 5-year prospective randomized study. Transplantation. 2009 Feb 27;87(4):546-8. doi: 10.1097/TP.0b013e3181949d2e.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20-99-001
Identifier Type: -
Identifier Source: org_study_id