ArticleBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2023
CAR-T Cells and the Kidney: Insights from the WHO Safety Database.
Article in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed.
- Hypophosphatemia after CAR-T cell therapy: a prospective study of inflammation, tubular injury and phosphate handling.Clinical kidney journal · 2026Article
- Kidney disease and transplantation in childhood cancer survivors.Pediatric nephrology (Berlin, Germany) · 2026Review
- Post-marketing Safety Assessment of CAR T-cell Therapies: Analysis of Individual Case Safety Reports in the VigiBase.Therapeutic innovation & regulatory science · 2025Article
- Investigating the Benefit-Risk Profile of Drugs: From Spontaneous Reporting Systems to Real-World Data for Pharmacovigilance.Methods in molecular biology (Clifton, N.J.) · 2025Article
- Novel therapeutic agents in clinical trials: emerging approaches in cancer therapy.Discover oncology · 2024Review
- Therapeutic effectiveness and safety profile of lanthanum carbonate in conjunction with calcium carbonate for managing hyperphosphatemia in hemodialysis patients: a meta-analysis of randomized controlled trials.American journal of translational research · 2024Review
- CAR T-cell therapy and the onco-nephrologist.Frontiers in nephrology · 2024Review
- Systemic toxicity of CAR-T therapy and potential monitoring indicators for toxicity prevention.Frontiers in immunology · 2024Review
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundChimeric antigen receptor T (CAR-T) cells have proven to be a game changer for treating several hematologic malignancies. Randomized controlled trials have highlighted potential life-threatening adverse drug reactions (ADRs), including cytokine release syndrome (CRS). Acute renal failure (ARF) has also been reported in 20% of the patients treated. However, an analysis of renal safety supported by large-scale real-life data seems warranted. PATIENTS AND
methodsWe queried VigiBase® for all reports of the Standardised MedDRA Query "acute renal failure" (ARF) involving a CAR-T cell, registered until 24 July 2022. Disproportionality for this ADR was analyzed through calculation of the Information Component [IC (95% confidence interval)]. A positive lower end of the 95% confidence interval of the IC is the threshold used in statistical signal detection in VigiBase®. The same analysis was carried out for various hydroelectrolytic disorders.
resultsWe gathered 224 reports of ARF, and 125 reports of hydroelectrolytic disorders involving CAR-T cells. CAR-T cells were disproportionately reported with ARF [IC 1.5 (1.3-1.7)], even after excluding reports mentioning CRS. A significant disproportionate reporting was also found for hypernatremia [IC 3.1 (2.2-3.8)], hyperphosphatemia [IC 3.1 (1.8-3.9)], hypophosphatemia [IC 2.0 (0.6-2.9)], metabolic acidosis [IC 1.8 (1.2-2.2)], hyponatremia [IC 1.6 (1.1-2.0)], and hypercalcemia [IC 1.4 (0.5-2.1)]. There was no disproportionate reporting of dyskalemia.
conclusionsThis study is limited by the inherent flaws of pharmacovigilance approaches. Nonetheless, our findings suggest that ARF and an array of hydroelectrolytic disorders are potential ADRs of CAR-T cell therapy, in real-life settings and in a nonselected population.
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