Clinical trial · Observational
Immune Checkpoint Inhibitors Nephrotoxicity
Application of Biomarkers of Renal Damage in Patients Treated With Immune Checkpoint Inhibitors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Antineoplastics Toxicity | — | UNRESOLVED | — |
| Kidney Injury | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early kidney damage biomarkers | Diagnostic Test | — | UNRESOLVED |
| Predisposition to kidney injury biomarkers | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control (no kidney injury)
- description
- Patients who receive ICI but no develop kidney injury
- interventionNames
- Diagnostic Test: Early kidney damage biomarkers
- Diagnostic Test: Predisposition to kidney injury biomarkers
- label
- Case (kidney injury)
- description
- Patients who receive ICI and develop kidney injury
- interventionNames
- Diagnostic Test: Early kidney damage biomarkers
- Diagnostic Test: Predisposition to kidney injury biomarkers
Primary outcomes (5)
- measure
- Change of urinary albumin
- timeFrame
- During 1 year at the times: pre ICI (before administering each cycle of ICI) and post ICI (one week after each administration of ICI)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Patients waiting for immunotherapy or combination immunotherapy / platinum compounds Exclusion Criteria: * Patients who are terminally ill * Patients who do not wish to sign the informed consent
References
Publications (1)
- DERIVEDVicente-Vicente L, Casanova AG, Tascon J, Prieto M, Morales AI. New Challenges in the Diagnosis of Kidney Damage Due to Immune Checkpoint Inhibitors Therapy: An Observational Clinical Study. Diagnostics (Basel). 2023 Jul 28;13(15):2524. doi: 10.3390/diagnostics13152524. PMID 37568887