TMCT04 - A RANDOMIZED CONTROLLED TRIAL OF URINE CXCL10 CHEMOKINE MONITORING POST-RENAL TRANSPLANT
Summary
The study will use a new screening test for rejection of transplanted kidney using urine CXCL10 testing.
In the first year after kidney transplant, the patient will have urine CXCL10 measured at their routine clinic visits. This test will be used to see if the patient is at risk of rejection of transplanted kidney.
If a patient is at risk of rejection, they may be “randomized” (like flipping a coin, heads or tails) to get a kidney transplant biopsy to check for rejection. Early diagnosis and treatment of rejection may help the kidney transplant stay healthy and last longer.
Eligibility
Eligible gender: Male, Female, Transgender, Other
Eligible ages: 18 to 100
Inclusion criteria:
Any new adult kidney transplant patient may be considered. The study coordinator will review your medical history to see if you qualify for this study. Participation is completely voluntary. Your medical care will stay the same, even if you do not participate.
Exclusion criteria:
Participants who are not eligible for this study:
Individuals meeting any of the following criteria will be excluded from participation:
1. Primary non-function;
2. ABO incompatible with exception of ABO light
3. Pre-transplant donor specific antibody (DSA) positive* (MFI>1000 OR positive flow cross-match);
4. HLA 0 DR + 0 DQ mis-match;
5. Presence of other transplanted organ or co-transplanted organ and/or previous bone marrow or stem cell transplant;
6. Followed outside of investigational center;
7. Participation in other interventional trials with other trial interventions occurring within 4 weeks prior to transplant or anytime post-transplant until study end at 12-months;
8. Intention not to use a maintenance immunosuppression regimen consisting of CNI and anti-proliferative agents;
9. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant’s ability to comply with study requirements or that may impact the quality or interpretation of the data. (ie. COVID-19 positive diagnosis at the time of enrolment)
Participate
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Additional information
Contact information
Ngan Lam, MD, FRCPC, MSc Associate Professor, Division of Nephrology Cumming School of Medicine, University of Calgary 3230 Hospital Drive NW, Calgary, AB, T2N 4Z6 Phone: (403) 210-7961 Fax: (403) 210-6660
Principal investigator:
Ngan Lam
Clinical trial:
Yes
REB-ID:
REB21-0702