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

Phase 4

Completed

• Conditions: Renal Transplantation
• Interventions: Drug: tacrolimus; Drug: CellCept; Drug: steroids (methylprednisone or prednisone)

• Registration Number: NCT00650468
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1999-11
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2008-03-17
• Study First Submitted QC: 2008-03-28
• Study First Posted: 2008-04-01
• Status Verified: 2009-03
• Last Update Submitted: 2011-11-15
• Last Update Posted: 2011-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 397

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	steroids (methylprednisone or prednisone)	long-term maintenance steroids
1	steroids (methylprednisone or prednisone)	early steroid cessation
2	tacrolimus	long-term maintenance steroids
1	tacrolimus	early steroid cessation
1	CellCept	early steroid cessation
2	CellCept	long-term maintenance steroids

Primary Outcome Measures

Name	Time	Method
Assessment of death, graft loss, or severe acute rejection	6 months, 12 months, yearly up to 5 years

Secondary Outcome Measures

Name	Time	Method
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