A Study Of Biomarkers Of Immune Checkpoint Inhibitors-Associated Nephrotoxicity

Overview

About this study

The purpose of this study is to prospectively validate urine cytokines (e.g. TNF-α and CXCL9) and urinary T cells as non-invasive biomarkers to distinguish between ICI-AIN versus non-ICI-AIN in patients who developed AKI. Among patients on ICI therapy who develop AKI with adjudication of etiology by clinical criteria and kidney biopsies, we will access the accuracy of biomarkers, including urine CXCL9 and TNF-α and urinary T cells for the differentiation of biopsy-proven ICI-AIN from other causes of AKI, e.g. acute tubular injury (i.e. non-ICI-AIN). Our hypothesis is that urine biomarkers will provide a non-invasive method to accurately distinguish between AIN and non-AIN causes of AKI in ICI patients. To correlate with urine biomarkers, blood will be obtained from samples collected during the time of AKI. Plasma and Peripheral Blood Mononuclear Cell (PBMC) will be obtained for the analysis of cytokines and immune phenotyping.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Study Population 1:

All Mayo Clinic-Rochester patients age 18 or older who initiate therapy with any type of immune checkpoint inhibitor (ICI) (e.g., anti-CTL-4 or anti-PD-1/PD-L1) for any type of malignancy, have an acute kidney injury (AKI), and provide informed consent.

Inclusions Criteria:

≥ 18 years old.
Seen at Mayo Clinic-Rochester.
Able to provide informed consent.
Diagnosed with any malignancy.
Initiation of any Immune Checkpoint Inhibitor (ICI) therapy:
- Ipilimumab, nivolumab, pembrolizumab or atezolizumab either as monotherapy or combination therapy.
Has Acute Kidney Injury (AKI) while on ICI therapy.

Exclusion Criteria:

Pregnancy
Kidney transplantation
End-stage kidney disease (ESKD) at time of ICI therapy.
Unable to provide Informed Consent.

Study Population 2:

All Mayo Clinic-Rochester patients age 18 or older who initiate therapy with any type of immune checkpoint inhibitor (ICI) (e.g., anti-CTL-4 or anti-PD-1/PD-L1) for any type of malignancy, without AKI, and provide informed consent.

Inclusion Criteria:

≥ 18 years old.
Seen at Mayo Clinic-Rochester.
Able to provide informed consent.
Diagnosed with any malignancy.
Initiation of any Immune Checkpoint Inhibitor (ICI) therapy:
- Ipilimumab, nivolumab, pembrolizumab or atezolizumab either as monotherapy or combination therapy.

Exclusion Criteria:

Kidney transplantation
Has AKI while on ICI therapy
End-stage kidney disease (ESKD) at time of ICI therapy.
Unable to provide Informed Consent.

Subject Population 3:

All Mayo Clinic-Rochester patients aged 18 or older, have any type of malignancy, not on ICI therapy, without AKI, and provide informed consent.

Inclusion Criteria:

≥ 18 years old.
Seen at Mayo Clinic-Rochester.
Able to provide informed consent.
Diagnosed with any malignancy.

Exclusion Criteria:

Initiation of any Immune Checkpoint Inhibitor (ICI) therapy.
Has AKI while on ICI therapy.
Pregnancy
Kidney transplantation
End-stage kidney disease (ESKD) at time of ICI therapy.
Unable to provide Informed Consent.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/18/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Sandra Herrmann	Open for enrollment	Contact information: RST Nephrology Hypertension Study Coordinator (800) 270-4637

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sandra Herrmann

Open for enrollment

Contact information:

RST Nephrology Hypertension Study Coordinator

(800) 270-4637

More information

Publications

Publications are currently not available

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