Clinical trial NCT00133172: Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection
Official title: Evaluation of the Long-term Safety and Efficacy of a Tacrolimus-based 5-day Steroid Rapid Withdrawal Immunoprophylactic Regimen in de Novo Renal Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Kidney Transplantation
Keywords: Treatment Efficacy
Treatment Effectiveness
Anti-rejection therapy
Immunosuppression
Antirejection
Renal Transplantation
Transplantation, Renal
Transplantation, Kidney
Grafting, Kidney
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Canada, Inc.
First posted: 2005-08-23
Enrollment: 85
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: The purpose of this study is to compare the safety and efficacy of a tacrolimus-based 5-day steroid rapid withdrawal immunoprophylactic regimen in de novo renal transplantation.


Eligibility criteria: Inclusion Criteria:

* Subject or legally acceptable guardian has signed and dated a Research Ethics Board (REB)-approved informed consent form and is willing and able to follow study procedures.
* Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant.
* Subject is 18 years of age or over at the time of 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 60 years of age or older
* Recipients of donation after cardiac death (DCD) donors
* Recipients of a combined transplant (e.g. kidney-pancreas, -lung, -heart)
* Subjects with a second renal allograft who had their original graft for \< 2 years, unless the initial graft was lost in the early (1 year or less) post transplant course due to a technical or surgical failure
* Subjects with a current/latest pre-transplant panel of reactive antibodies (PRA) \>20
* Subjects with hepatitis B \& C, HIV or cancer (excluding successfully excised squamous or basal cell carcinoma)
* Subjects receiving an allograft with cold ischemia time 24 hours or greater
* Subjects who have received an investigational drug within three months prior to randomization
* Subjects who are breastfeeding
* Subjects with known hypersensitivity to tacrolimus, mycophenolate mofetil, methylprednisolone, basiliximab, prednisone, or any related drugs or their excipients
* Subjects with significant disease (e.g. uncontrolled infection) or disability (e.g. cognitive deficit) that prevents understanding of or adherence to the protocol

Primary outcomes:
measure: Combined incidence of biopsy proven subclinical rejection (BPSCR) and biopsy proven clinical acute rejection (BPCAR)
timeFrame: 3 months post transplant
Secondary outcomes:
measure: Biopsy proven chronic allograft nephropathy(CAN)
timeFrame: 2 years post transplant
measure: Patient and graft survival rates
timeFrame: End of study (5 years)
Other outcomes:
Locations:
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: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
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: Medical Monitor
role: STUDY_DIRECTOR
References: