Immune Checkpoint Inhibitors Nephrotoxicity

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

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.

Eligibility

Primary outcome measure(s)

• Change of urinary albumin — During 1 year at the times: pre ICI (before administering each cycle of ICI) and post ICI (one week after each administration of ICI)
  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.
• Change of urinary N-Acetyl-β-D-Glucosaminidase (NAG) — During 1 year at the times: pre ICI (before administering each cycle of ICI) and post ICI (one week after each administration of ICI)
  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.
• Change of urinary Kidney Injury Molecule-1 (KIM-1) — During 1 year at the times: pre ICI (before administering each cycle of ICI) and post ICI (one week after each administration of ICI)
  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.
• Change of urinary Neutrophil gelatinase-associated lipocalin (NGAL) — During 1 year at the times: pre ICI (before administering each cycle of ICI) and post ICI (one week after each administration of ICI)
  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.
• Change of urinary biomarkers of predisposition to kidney injury — During 1 year at the times: pre ICI (before administering each cycle of ICI) and post ICI (one week after each administration of ICI)
  It is a group of markers that are in patent phase so their names can not be mentioned. They are able to detect the susceptibility to kidney damage before administering a nephrotoxic agent. 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.

Trial sites (2)

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