Health-Related Quality of Life in Clinical Trials of CKD Progression

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Abstract
Key Points: EuroQol Five-Dimension, 36-Item Short Form Health Survey, and Kidney Disease Quality of Life-36 were the most common instruments measuring health-related quality of life in trials of disease-modifying pharmacologic therapies in nondialysis CKD. Health-related quality-of-life effects were instrument and domain specific, seen more often in physical and kidney-specific domains of Kidney Disease Quality of Life-36. Future CKD trials should use kidney-specific health-related quality-of-life measures, report all domains with multiple metrics, and discuss implications of design factors to aid interpretation. Background: Several novel pharmacologic therapies for CKD have been shown to reduce risks of disease progression, cardiovascular events, and mortality. However, their effects on health-related quality of life (HRQoL) remain scattered across trials and are difficult to interpret, owing to variability in instruments used and other design-related factors. Methods: PubMed and Web of Science were searched for randomized clinical trials of pharmacologic interventions aimed at slowing CKD progression in adults with nondialysis CKD, published between January 2000 and January 2026. Two authors independently screened and extracted data. Data on study characteristics, HRQoL instruments used, and intervention effects were synthesized descriptively, and key methodological considerations were reviewed. Results: Of 16,624 screened records, 13 trials collected HRQoL data. HRQoL was measured mainly using the EuroQol Five-Dimension questionnaire (EQ-5D) ( n =8), 36-Item Short Form Health Survey (SF-36) ( n =4), or Kidney Disease Quality of Life-36 (KDQOL-36) questionnaire ( n =5). Nine trials reported the effects of interventions on HRQoL. Three demonstrated statistically significant effects in at least one HRQoL domain, all involving interventions that also slowed CKD progression. Effects were generally greater for physical than for mental health domains and were detected more frequently using the disease-specific KDQOL-36 questionnaire, particularly in the symptoms and effects domains, than using the generic EQ-5D instrument. Observed population average intervention effects were generally below conventional minimal clinically important difference thresholds at the population level, although individual-level benefits were evident. Conclusions: The impact of disease-modifying therapies on HRQoL in nondialysis CKD was heterogeneous, instrument dependent, and domain specific.

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