Status:
COMPLETED
A Pilot Study Comparing the Use of Low-target Versus Conventional Target Advagraf
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Astellas Pharma Canada, Inc.
Conditions:
Acute Graft Rejection
Diabetes
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
While the incidence of acute rejection and early graft loss have improved dramatically with the advent of newer immunosuppressant medications, improvements in long-term patient and allograft survival ...
Detailed Description
Purpose This study has been designed to test whether using Thymoglobulin with low dose tacrolimus and early steroid withdrawal will minimize both kidney rejection and the development of new onset diab...
Eligibility Criteria
Inclusion
- Male or female patients over 18 years of age who receive a deceased, living unrelated or living related donor renal transplant
- No history of pre-existing diabetes mellitus
- Not using diabetic medications (insulin, hypoglycemic agents) at the time of transplantation
- Random plasma glucose level \<11.1 at the time of transplantation
- Peak PRA (panel reactive antibody) \<30%
- Females capable of becoming pregnant must have a negative pregnancy test at baseline and are required to practice an approved method of birth control for the duration of the study and for a period of three months following discontinuation of study medication
- The patient has given written informed consent to participate in the study
Exclusion
- Patients with primary non-function
- Peak PRA\>=30%
- Multiple organ transplants
- HLA (human leukocyte antigen) identical living donor transplant recipients
- Cold ischemia time over 36 hours
- Nonheart beating donor kidney recipients
- Pediatric donor kidney recipients
- Donor age\>=65 years
- Patients who are known to have a positive hepatitis C serology, who are human immunodeficiency virus (HIV) or Hepatitis B surface antigen positive. Laboratory results obtained within 6 months prior to study entry are acceptable. Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C will be excluded.
- Patients who are Epstein-Barr virus (EBV) negative and are receiving a transplant from an EBV-positive donor (mismatch).
- Presence of any severe allergy requiring acute (within 4 weeks of baseline) or chronic treatment, or hypersensitivity to drugs similar to those used in the study
- Patients with systemic infections
- Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator, preclude enrollment in this trial
- Inability to cooperate or communicate with the investigator
Key Trial Info
Start Date :
June 24 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01265537
Start Date
June 24 2011
End Date
October 11 2019
Last Update
January 23 2025
Active Locations (1)
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1
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6