NCT00650468

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 397 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
DRUG	tacrolimus	Oral
DRUG	CellCept	IV or Oral
DRUG	steroids (methylprednisone or prednisone)	IV or Oral

Timeline

• Start date: 1999-11-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2008-04-01
• Last updated: 2011-11-17

Locations

29 sites across 1 country: United States