A Study to Compare Early Steroid Withdrawal and Long-Term Steroid Maintenance Therapy in Kidney Transplant Patients

Renal Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00650468
• Other study ID #: 20-99-001
• Status: Completed
• Phase: Phase 4
• First received: March 17, 2008
• Last updated: November 15, 2011
• Start date: November 1999
• Est. completion date: December 2007

Study information

• Verified date: March 2009
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A study comparing the early withdrawal of steroids to long-term maintenance steroid therapy in Kidney Transplant Patients receiving Prograf and Cellcept

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion:

• Patient is between post kidney transplant day 3-7 and no requirement for dialysis

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Drug:
• tacrolimus
Oral
• CellCept
IV or Oral
• steroids (methylprednisone or prednisone)
IV or Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of death, graft loss, or severe acute rejection		6 months, 12 months, yearly up to 5 years	No
Secondary	Comparison of patient and graf survival		6 months, 12 months, yearly up to 5 years	No
Secondary	Incidence and severity of acute rejection		6 months, 12 months, yearly up to 5 years	No
Secondary	Need for antilymphocyte treatment		6 months, 12 months, yearly up to 5 years	No
Secondary	Graft function		6 month, 12 months, yearly up to 5 years	No
Secondary	Framingham Coronary Heart Disease Risk Factors		6 months, 12 months, yearly up to 5 years	No