A Study to Compare Early Steroid Withdrawal and Long-Term Steroid Maintenance Therapy in Kidney Transplant Patients
A Prospective, Randomized, Multi-Center Double-Blind Study of Early Corticosteroid Cessation vs. Long Term Corticosteroid Therapy With Prograf and CellCept in Primary Renal Transplant Patients
1 other identifier
interventional
397
1 country
29
Brief Summary
A study comparing the early withdrawal of steroids to long-term maintenance steroid therapy in Kidney Transplant Patients receiving Prograf and Cellcept
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 1999
Longer than P75 for phase_4
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 17, 2008
CompletedFirst Posted
Study publicly available on registry
April 1, 2008
CompletedNovember 17, 2011
March 1, 2009
8.1 years
March 17, 2008
November 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of death, graft loss, or severe acute rejection
6 months, 12 months, yearly up to 5 years
Secondary Outcomes (5)
Comparison of patient and graf survival
6 months, 12 months, yearly up to 5 years
Incidence and severity of acute rejection
6 months, 12 months, yearly up to 5 years
Need for antilymphocyte treatment
6 months, 12 months, yearly up to 5 years
Graft function
6 month, 12 months, yearly up to 5 years
Framingham Coronary Heart Disease Risk Factors
6 months, 12 months, yearly up to 5 years
Study Arms (2)
1
EXPERIMENTALearly steroid cessation
2
EXPERIMENTALlong-term maintenance steroids
Interventions
IV or Oral
Eligibility Criteria
You may qualify if:
- Patient is between post kidney transplant day 3-7 and no requirement for dialysis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Loma Linda, California, 92354, United States
Unknown Facility
Los Angeles, California, 90057, United States
Unknown Facility
Denver, Colorado, 80262, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Lexington, Kentucky, 40536, United States
Unknown Facility
New Orleans, Louisiana, 70121, United States
Unknown Facility
Baltimore, Maryland, 21201, United States
Unknown Facility
Boston, Massachusetts, 02111, United States
Unknown Facility
Detroit, Michigan, 48202, United States
Unknown Facility
Minneapolis, Minnesota, 55455, United States
Unknown Facility
Rochester, Minnesota, 55905, United States
Unknown Facility
Omaha, Nebraska, 68198, United States
Unknown Facility
New Brunswick, New Jersey, 08903, United States
Unknown Facility
Buffalo, New York, 14203, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
New York, New York, 10029, United States
Unknown Facility
Cincinnati, Ohio, 45267, United States
Unknown Facility
Cleveland, Ohio, 44106, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
Providence, Rhode Island, 02903, United States
Unknown Facility
Memphis, Tennessee, 38163, United States
Unknown Facility
Nashville, Tennessee, 37232, United States
Unknown Facility
Galveston, Texas, 77555, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Salt Lake City, Utah, 84103, United States
Unknown Facility
Salt Lake City, Utah, 84132, United States
Unknown Facility
Madison, Wisconsin, 53792, United States
Unknown Facility
Milwaukee, Wisconsin, 53226, United States
Related Publications (4)
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.
PMID: 15848538BACKGROUNDWoodle 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.
PMID: 18936569BACKGROUNDGaber 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.
PMID: 23423269DERIVEDDelgado 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.
PMID: 19307792DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
central contact
Astellas Pharma US, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 17, 2008
First Posted
April 1, 2008
Study Start
November 1, 1999
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
November 17, 2011
Record last verified: 2009-03