Urine CXCL10 Monitoring for Kidney Transplant Rejection

Recruiting at 8 trial locations

Overseen By Michelle Lesyk, RN, BN

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Manitoba

Must be taking: Calcineurin inhibitors

Disqualifiers: Blood group incompatible, DSA positive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 13

420 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase II-III multi-center prospective randomized controlled clinical trial of incident adult renal transplant patients. The primary objective of this study is to determine if the early treatment of rejection, as detected by urinary CXCL10, will improve renal allograft outcomes.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should intend to use a maintenance immunosuppression regimen with specific drugs, so you may need to adjust your medications accordingly.

What data supports the effectiveness of the treatment Kidney transplant biopsy for monitoring kidney transplant rejection?

Research shows that monitoring urine levels of CXCL10 can help detect early signs of kidney transplant rejection, often before symptoms appear, which can improve outcomes by allowing earlier intervention. ^{1 2 3 4 5}

Is urine CXCL10 monitoring safe for humans?

The research does not provide specific safety data for urine CXCL10 monitoring, but it is used as a noninvasive method to detect kidney transplant rejection, suggesting it is generally considered safe for monitoring purposes. ^{1 2 3 5 6}

How is urine CXCL10 monitoring different from other treatments for kidney transplant rejection?

Urine CXCL10 monitoring is unique because it is a noninvasive method that uses a biomarker to detect kidney transplant rejection earlier than standard monitoring methods. This approach can identify subclinical rejection (rejection without obvious symptoms) and early clinical rejection, potentially improving outcomes by allowing for earlier intervention. ^{1 2 5 6 7}

Research Team

Julie Ho, MD

Principal Investigator

University of Manitoba

Eligibility Criteria

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.

Inclusion Criteria

Participants must be able to understand and provide written informed consent

Confirmed elevated urine CXCL10:Cr without a urinary tract infection or gross hematuria.

Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

I have antibodies against the transplant donor.

I have had an organ transplant.

My organ transplant has failed to work.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Post-transplant Surveillance

Routine urine CXCL10 screening from 2 weeks to 9 months post-transplant to monitor for elevated levels indicating risk of rejection

9 months

Intervention

Participants with high urine CXCL10 undergo randomization; intervention arm receives kidney biopsy and treatment for subclinical rejection, control arm continues routine surveillance

12 months

12-month study exit visit with protocol biopsy

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of long-term outcomes

12 months

Treatment Details

Interventions

• Kidney transplant biopsy

Trial Overview 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.

Participant Groups

Group I: Intervention Experimental Treatment 1 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: Control Active Control 1 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.

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Canadian National Transplant Research Program

Collaborator

Trials

9

Recruited

1,600+

References

1. United States pubmed.ncbi.nlm.nih.gov

Automated Urinary Chemokine Assays for Noninvasive Detection of Kidney Transplant Rejection: A Prospective Cohort Study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Multicentre randomised controlled trial protocol of urine CXCL10 monitoring strategy in kidney transplant recipients. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Early Low Urinary CXCL9 and CXCL10 Might Predict Immunological Quiescence in Clinically and Histologically Stable Kidney Recipients. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Elevated Urinary Matrix Metalloproteinase-7 Detects Underlying Renal Allograft Inflammation and Injury. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Urine CXCL10 to Assess BK Polyomavirus Replication After Kidney Transplantation. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Technical Considerations and Confounders for Urine CXCL10 Chemokine Measurement. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Multicenter Validation of a Urine CXCL10 Assay for Noninvasive Monitoring of Renal Transplants. [2023]