Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma Canada, Inc.
• Treatments: Methylprednisolone; Prednisone; Tacrolimus

Criteria

Inclusion Criteria:

• Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant

• If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods

Exclusion Criteria:

• Recipients of a kidney from a donor over 65 years of age

• Recipient of non-related donor kidney with peak pre-transplant PRA > 50

• Subject has lost a previous graft to rejection less than one year from transplant

• Subject who has received an investigational drug within three months prior to randomization

• Subjects who are pregnant or breastfeeding

• Subject receives a kidney lacking a pre-implantation biopsy

• Subject has significant disease or disability (e.g. malignancy or uncontrolled infection) which prevents adherence to the protocol