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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
Unnamed facility
Palo Alto, California, United States
Unnamed facility
Calgary, Alberta, Canada
Unnamed facility
Edmonton, Alberta, Canada
Unnamed facility
Vancouver, British Columbia, Canada
The incidence of interstitial fibrosis/tubular atrophy as defined by Banff interstitial and tubular chronic changes of ci + ct of 2 or more at 6 months
Time frame: 6 months
The incidence of subclinical rejection at 6 months
Time frame: 6 months
Prevalence of chronic renal histopathology at 24 months
Time frame: 24 months
Renal function as determined by serum creatinine and 24 hour urine creatinine clearance and protein excretion
Time frame: 6, 12 and 24 moths
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Vancouver, British Columbia, Canada
Unnamed facility
Winnipeg, Manitoba, Canada
Unnamed facility
Hamilton, Ontario, Canada
Unnamed facility
Ottawa, Ontario, Canada
Unnamed facility
Montreal, Quebec, Canada
Unnamed facility
Montreal, Quebec, Canada
...and 2 more locations