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Immune Checkpoint Inhibitors Nephrotoxicity

NCT04902846 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 220

Last updated 2025-02-26

No results posted yet for this study

Summary

In recent years, immunotherapy has been postulated as one of the most effective strategy in the fight against cancer. The greatest success in this field has been achieved through the inhibition of molecules involved in the brake of the adaptive immune response. The compounds capable of blocking the action of these molecules constitute the "immune checkpoint inhibitors" (ICI). Despite its efficacy, the treatment with ICI causes adverse effects, and in the case of kidney damage, the prognosis has been shown to worsen in cancer patients who develop renal dysfunction. Currently, the diagnosis based on laboratory tests is insufficient to predict the underlying kidney injury and identify the type of damage. The hypothesis proposed that the renal lesion could be subclinical, and therefore the possibility of using new urinary biomarkers could be a useful diagnostic tool that would allow these patients to be managed in a preventive (risk markers) and early way (early markers), and even to elucidate if renal damage is due to this therapy or to other factors (differential diagnostic markers). To develop this hypothesis it is proposed to validate biomarkers in patients treated with ICI by developing a prospective study. The diagnostic products derived from this study will improve the clinical practice of cancer treatment with ICI, and therefore the expectancy and quality of life of patients.

Conditions

  • Kidney Injury
  • Antineoplastics Toxicity

Interventions

DIAGNOSTIC_TEST

Early kidney damage biomarkers

In the urine samples of these patients, a series of biomarkers of early kidney damage and / or predisposition to kidney damage will be measured.

DIAGNOSTIC_TEST

Predisposition to kidney injury biomarkers

In the urine samples of these patients, a series of biomarkers of predisposition to kidney damage will be measured.

Sponsors & Collaborators

  • Instituto de Investigación Biomédica de Salamanca

    collaborator OTHER

  • Hospital Clínico Universitario de Valladolid

    collaborator OTHER

  • University of Salamanca

    collaborator OTHER

  • R. Laura Vicente Vicente

    lead OTHER

Principal Investigators

  • Ana Isabel Morales Martín, PhD · University of Salamanca

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-19
Primary Completion
2028-04-23
Completion
2030-12-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04902846 on ClinicalTrials.gov