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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

Must not have

Pre-transplant donor specific antibody (DSA) positive (MFI>1000 OR positive flow crossmatch)

Presence of other transplanted organ or co-transplanted organ

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6, 12, 24 and 60 months post-transplant

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am an adult who has received a kidney transplant from either a living or deceased donor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have antibodies against the transplant donor.

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I have had an organ transplant.

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My organ transplant has failed to work.

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My blood type does not match the donor's.

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I cannot undergo a biopsy or rejection treatment due to health risks.

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I have not been in any drug studies since my transplant.

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I plan not to use certain immune-suppressing drugs after my treatment.

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My immune system markers match the trial requirements.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 12, 24 and 60 months post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical indication biopsy-proven acute rejection

De novo donor specific antibody development

Death-censored graft loss

+2 more

Secondary study objectives

Albuminuria >300mg/day

Cost-effectiveness of urine CXCL10 monitoring strategy

Days from transplantation to clinical-biopsy proven rejection

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 9Eligibility criteria met