Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection

Phase 4 Completed 240 enrolled Astellas Pharma Inc Astellas Pharma Canada, Inc. · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2001-09
Primary completion: 2004-07
Completion: 2006-01

Publications

Background Rush DN, Cockfield SM, Nickerson PW, Arlen DJ, Boucher A, Busque S, Girardin CE, Knoll GA, Lachance JG, Landsberg DN, Shapiro RJ, Shoker A, Yilmaz S. Factors associated with progression of interstitial fibrosis in renal transplant patients receiving tacrolimus and mycophenolate mofetil. Transplantation. 2009 Oct 15;88(7):897-903. doi: 10.1097/TP.0b013e3181b723f4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Background	MMF	Unknown	—	Oral
Background	Prednisone	Other / unclassified	—	Oral
Background	Tacrolimus	Small molecule	—	Oral

Indications

No indication recorded.