A Pilot Study Comparing the Use of Low-target Versus Conventional Target Advagraf

• Status: Completed
• Trial end date: 2019-10-11
• Target enrollment: 0
• Participant gender: All

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 after kidney transplantation have not been achieved. The specific drug combination that provides the best outcomes with the least amount of side effects is not known. Each kidney transplant center uses the combination of drugs that they believe is optimal. This study is about identifying whether drugs that are currently approved for use in kidney transplantation can be used in a new combination safely and with potentially fewer side effects than the drug combinations that are currently used at St. Paul's Hospital and other transplant centres.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborator: Astellas Pharma Canada, Inc.
• Treatments: Basiliximab; Mycophenolate mofetil; Tacrolimus

Criteria

Inclusion Criteria:

1. Male or female patients over 18 years of age who receive a deceased, living unrelated or living related donor renal transplant

2. No history of pre-existing diabetes mellitus

3. Not using diabetic medications (insulin, hypoglycemic agents) at the time of transplantation

4. Random plasma glucose level <11.1 at the time of transplantation

5. Peak PRA (panel reactive antibody) <30%

6. 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

7. The patient has given written informed consent to participate in the study

Exclusion Criteria:

1. Patients with primary non-function

2. Peak PRA>=30%

3. Multiple organ transplants

4. HLA (human leukocyte antigen) identical living donor transplant recipients

5. Cold ischemia time over 36 hours

6. Nonheart beating donor kidney recipients

7. Pediatric donor kidney recipients

8. Donor age>=65 years

9. 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.

10. Patients who are Epstein-Barr virus (EBV) negative and are receiving a transplant from an EBV-positive donor (mismatch).

11. 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

12. Patients with systemic infections

13. Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator, preclude enrollment in this trial

14. Inability to cooperate or communicate with the investigator