NCT00885820

Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection

The Effects of Treatment of Subclinical Rejection on Renal Histology and Graft Function in Renal Transplant Patients Receiving Tacrolimus and Mycophenolate Mofetil

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicentre randomized, controlled trial (RCT) compared renal allograft histology and function in subjects treated with Tacrolimus + MMF + prednisone undergoing early protocol biopsies and treatment of subclinical rejection versus a non-protocol biopsy control group.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Tacrolimus	Oral
DRUG	MMF	Oral
DRUG	Corticosteroids (Prednisone)	Oral

Timeline

• Start date: 2001-09-01
• Primary completion: 2004-07-01
• Completion: 2006-01-01
• First posted: 2009-04-22
• Last updated: 2014-09-18

Locations

12 sites across 2 countries: United States, Canada