Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection

Completed · Phase 4

Conditions studied: Kidney Transplantation

In brief

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.

Key facts

Study ID

NCT00885820

Run by

Astellas Pharma Inc

People needed

240

Starts

2001-09-01

Expected to finish

2006-01-01

Last updated by the study team

2014-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Palo Alto, California, United States
• Study site — Calgary, Alberta, Canada
• Study site — Edmonton, Alberta, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Winnipeg, Manitoba, Canada
• Study site — Hamilton, Ontario, Canada
• Study site — Ottawa, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Québec, Quebec, Canada
• Study site — Saskatoon, Saskatchewan, Canada

Full record on ClinicalTrials.gov

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