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Urine CXCL10 Monitoring for Kidney Transplant Rejection
Phase 2 & 3
Recruiting
Led By Julie Ho, MD
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Incident adult (age ≥18) renal transplant patients with a living or deceased donor kidney transplant
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 12, 24 and 60 months post-transplant
Awards & highlights
Study Summary
This trial is for people who have recently gotten a kidney transplant. It will test whether early treatment of rejection, as detected by a protein in urine, will improve the transplant's outcome.
Who is the study for?
Adults over 18 who've recently had a kidney transplant can join this trial. They must understand the study, agree to follow its rules, and be available for its duration. Participants need an elevated urine CXCL10 level without infection or significant bleeding in their urine. Those with certain immune mismatches, other organ transplants, conditions affecting safe participation or data quality, incompatible blood types, high antibody levels against the donor kidney, or not following standard anti-rejection drugs cannot join.Check my eligibility
What is being tested?
The trial is testing if treating kidney transplant rejection early based on urinary CXCL10 levels improves long-term outcomes of the new kidney. It's a controlled study where some patients will receive treatment based on these biomarker levels while others may follow standard care protocols.See study design
What are the potential side effects?
Potential side effects are related to the biopsy procedure and include pain at the biopsy site, bleeding into the urine (hematuria), infection risk from the procedure itself and possible injury to surrounding organs during tissue sampling.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult who has received a kidney transplant from either a living or deceased donor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6, 12, 24 and 60 months post-transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 12, 24 and 60 months post-transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical indication biopsy-proven acute rejection
De novo donor specific antibody development
Death-censored graft loss
+2 moreSecondary outcome measures
Albuminuria >300mg/day
Cost-effectiveness of urine CXCL10 monitoring strategy
Days from transplantation to clinical-biopsy proven rejection
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Participants with high urine CXCL10 randomized to the Intervention Arm will undergo a kidney transplant biopsy to check for rejection. Biopsy-proven subclinical rejection will be treated per study protocol.
Group II: ControlActive Control1 Intervention
Participants with high urine CXCL10 randomized to the Control Arm will continue routine post-transplant surveillance with serum creatinine and proteinuria; serial urine samples will continue to be collected and analyzed (blinded), but not used to direct care.
Find a Location
Who is running the clinical trial?
University of ManitobaLead Sponsor
595 Previous Clinical Trials
199,061 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,453,147 Total Patients Enrolled
Canadian National Transplant Research ProgramOTHER
8 Previous Clinical Trials
1,160 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have antibodies against the transplant donor.I have had an organ transplant.My organ transplant has failed to work.My blood type does not match the donor's.I cannot undergo a biopsy or rejection treatment due to health risks.I have not been in any drug studies since my transplant.I plan not to use certain immune-suppressing drugs after my treatment.I am an adult who has received a kidney transplant from either a living or deceased donor.My immune system markers match the trial requirements.My ethnicity or gender does not affect my eligibility.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many locations are conducting this research?
"This clinical trial is being conducted at 6 locations, these include the University of Manitoba, Transplant Manitoba Adult Kidney Program in Winnipeg, Université Laval in Québec City and McGill in Montreal. There are also 6 other active sites."
Answered by AI
Are there any more appointments available for this research?
"Yes, as the most recent update on clinicaltrials.gov shows, this study is still recruiting patients. The trial was first posted on April 3rd, 2018 and updated May 24th, 2022."
Answered by AI
What are the benefits that researchers hope to see from this clinical trial?
"The primary outcome being tracked in this study, which will last for 12 months post-transplant, is death-censored graft loss. Additionally, the research team is examining albuminuria >300mg/day (urine albumin: Cr ratio), cost-effectiveness of urine CXCL10 monitoring strategy (costs of urine CXCL10 screening), and renal allograft function (change in eGFR [slope, ∆] and graft function [eGFR] [absolute, mL/min])."
Answered by AI
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