N/A
N=30
A Pilot Study Comparing the Use of Low-target Versus Conventional Target Advagraf
Acute Graft Rejection · Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01265537 ↗Enrolled (actual)
30
Serious AEs
50.0%
Results posted
Feb 2020
Primary outcome: Primary: Number of Participants With New Onset Diabetes After Transplant (NODAT) or Acute Rejection — 2; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tacrolimus (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of British Columbia
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With New Onset Diabetes After Transplant (NODAT) or Acute Rejection |
2; 2 | — |
| SECONDARY Number of Participant Deaths |
0; 0 | — |
| SECONDARY Number of Participants With Graft Failure |
0; 0 | — |
| SECONDARY Number of Participants With Dialysis Events |
1; 3 | — |
| SECONDARY Number of Participants With Infection Events |
5; 5 | — |
| SECONDARY Number of Participants With Hospitalization Events |
0; 4 | — |
| SECONDARY Number of Participants With Malignancy Events |
0; 1 | — |
| SECONDARY Number of Participants With Cardiovascular Event |
0; 0 | — |
| SECONDARY Number of Any Leukopenia Events |
11; 3 | — |
| SECONDARY Number of Leukopenia Events on ≥2 Occasions |
6; 0 | — |
| SECONDARY Change From Baseline in Weight |
2.8; 1.5 | — |
| SECONDARY eGFR at 6 Months |
56; 51 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 =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
Data sourced from ClinicalTrials.gov (NCT01265537). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.