Clinical trial NCT00885820: Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection
Official title: The Effects of Treatment of Subclinical Rejection on Renal Histology and Graft Function in Renal Transplant Patients Receiving Tacrolimus and Mycophenolate Mofetil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Keywords: Kidney Transplantation
Tacrolimus
Immunosuppression
Graft Survival
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Canada, Inc.
First posted: 2009-04-22
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 treatment of subclinical rejection versus a non-protocol biopsy control group.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: The incidence of subclinical rejection at 6 months
timeFrame: 6 months
measure: Prevalence of chronic renal histopathology at 24 months
timeFrame: 24 months
measure: Renal function as determined by serum creatinine and 24 hour urine creatinine clearance and protein excretion
timeFrame: 6, 12 and 24 moths
Other outcomes:
Locations:
city: Palo Alto
country: United States
state: California
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Hamilton
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
Study officials:
affiliation: Astellas Pharma Canada, Inc.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: 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.