Immune Checkpoint Inhibitors Nephrotoxicity

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorR. Laura Vicente Vicente

About this trial

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.

Eligibility criteria

Qualifiers

Patients waiting for immunotherapy or combination immunotherapy / platinum compounds

Disqualifiers

Patients who are terminally ill

Patients who do not wish to sign the informed consent

Trial design

Treatments tested in this trial

  • Early kidney damage biomarkers
  • Predisposition to kidney injury biomarkers

Treatment groups

220 Participants
are divided into 2 treatment groups

Sponsors and collaborators

R. Laura Vicente Vicente

Lead sponsor

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Sponsor institution

Instituto de Investigación Biomédica de Salamanca

Collaborator

Hospital Clínico Universitario de Valladolid

Collaborator

University of Salamanca

Collaborator