Status:
COMPLETED
Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma Canada, Inc.
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 treatm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00885820
Start Date
September 1 2001
End Date
January 1 2006
Last Update
September 18 2014
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Palo Alto, California, United States, 94304-1510
2
Calgary, Alberta, Canada, T2N 2T9
3
Edmonton, Alberta, Canada, T6G 2B7
4
Vancouver, British Columbia, Canada, V5Z 1M9