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

This trial does not accept healthy volunteers

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 population

Patients who will receive ICI as part of a diagnostic or interventional procedure

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

220 Participants

are divided into 2 treatment groups

Group A: Control (no kidney injury)2 interventions

Group B: Case (kidney injury)2 interventions

Trial outcomes

Primary outcomes

1

Change of urinary albumin

It is a biomarker of early kidney damage. It is able to detect kidney damage in the early stages, before the clinical markers creatinine and plasma urea. There are no reference values for humans, so the means of non-smoking patients without risk factors (group 1) should be compared with the rest of the groups. This biomarker will be measured at different times to evaluate its evolution and compare it against the baseline value.

Time frame

During 1 year at the times: pre ICI (before administering each cycle of ICI) and post ICI (one week after each administration of ICI)

2

Change of urinary N-Acetyl-β-D-Glucosaminidase (NAG)

It is an enzyme whose urinary excretion is elevated in case of kidney damage. It is capable of detecting damage before the classic plasma creatinin and urea markers. There are no reference values for humans, so the means of non-smoking patients without risk factors (group 1) should be compared with the rest of the groups. This biomarker will be measured at different times to evaluate its evolution and compare it against the baseline value.

Time frame

During 1 year at the times: pre ICI (before administering each cycle of ICI) and post ICI (one week after each administration of ICI)

3

Change of urinary Kidney Injury Molecule-1 (KIM-1)

It is a biomarker of early kidney damage. It is able to detect kidney damage in the early stages, before the clinical markers creatinine and plasma urea. There are no reference values for humans, so the means of non-smoking patients without risk factors (group 1) should be compared with the rest of the groups. This biomarker will be measured at different times to evaluate its evolution and compare it against the baseline value.

Time frame

During 1 year at the times: pre ICI (before administering each cycle of ICI) and post ICI (one week after each administration of ICI)

4

Change of urinary Neutrophil gelatinase-associated lipocalin (NGAL)

It is a biomarker of early kidney damage. It is able to detect kidney damage in the early stages, before the clinical markers creatinine and plasma urea. There are no reference values for humans, so the means of non-smoking patients without risk factors (group 1) should be compared with the rest of the groups. This biomarker will be measured at different times to evaluate its evolution and compare it against the baseline value.

Time frame

During 1 year at the times: pre ICI (before administering each cycle of ICI) and post ICI (one week after each administration of ICI)

Secondary outcomes

1

Body weight

Body weight will be measured to each patient and expressed in kilograms

Time frame

These data will be collected once, at time 0 (moment of enrollment in the study)

2

Height

The height will be measured to each patient and expressed in meters

Time frame

These data will be collected once, at time 0 (moment of enrollment in the study)

3

Body mass index (BMI)

Weight and height will be combined to report BMI in kg/m\^2

Time frame

These data will be collected once, at time 0 (moment of enrollment in the study)

4

Age

Through the year of birth, the patient's age will be calculated, which will be expressed in years.

Time frame

These data will be collected once, at time 0 (moment of enrollment in the study)

Immune Checkpoint Inhibitors Nephrotoxicity

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial population

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts