Sex in CKD trials: representation and treatment effects of cardiorenoprotective therapies
- Design
- Retrospective cohort · Intermediate outcome
- Match to healthy normal-weight adults aged 55–75
- Different population[Auto] Participants selected for chronic kidney disease (age/BMI not reported in abstract).
- Could weight loss explain it?
- Unknown[Auto] Not addressed in abstract.
- Study tier
- Study tier 3[Auto] Observational design; confounding by indication and healthy-user effects cannot be excluded (auto-provisional).
- Assessment
- Version 1 · automatic, not yet reviewed by a person · Sep 13, 2026
Study facts come from the paper. Population match, weight-loss explanation and study tier are our judgments, made against the reference group of healthy normal-weight adults aged 55–75.
[Auto, unreviewed; quoted from abstract conclusions] Women remain underrepresented in cardiorenoprotective therapy trials, with limited sex-specific outcome reporting. Historical benchmarking indicates that successive advances in CKD pharmacotherapy have not been accompanied by demonstrable improvement in the sex representativeness of the evidence base.
01Findings
What the study reported
- Drugs
- Class unspecified
- Primary outcome
- Not extracted
- Effect
- Not extracted
- 95% confidence interval
- Not extracted
- Follow-up
- Not stated
- Adverse events
- Not extracted
- Limitations
- Auto-classified from abstract only; effect estimates, adverse events and limitations not extracted. Requires manual review.
Who was studied
- Diabetes status
- diabetes mentioned
- Ckd status
- chronic kidney disease present in population (see abstract)
- Baseline condition
- chronic kidney disease
Study quality details
- Study design
- Retrospective cohort
- Sample size
- not extracted
- Randomization
- no
- Blinding
- not stated
- Comparator
- not stated
- Follow up duration
- not stated
- Outcome type
- intermediate
- Replication
- not assessed (auto)
- Consistency with other evidence
- not assessed (auto)
- Population applicability
- INDIRECT
- Statistical precision
- CI reported: 95% CI, -0
- Risk of bias
- not assessed (auto)
- Funding conflicts
- unclear
- Peer review status
- yes
02Funding
Funding and conflicts
- Funding
- not reported in abstract
- Industry funded
- Unclear
- Manufacturer
- None identified
- Sponsor role
- not reported in abstract
- Author conflicts
- not available in metadata
- Independent replication
- unknown
Funding is shown on every study and never used to score it.
04Source
The source, as retrieved
Abstract
[BACKGROUND] Women comprise a substantial proportion of the chronic kidney disease (CKD) population and differ from men in disease phenotype, progression, and treatment exposure. Underrepresentation of women and limited sex-specific reporting may therefore reduce the generalizability of evidence from contemporary CKD trials. [METHODS] We conducted a meta-epidemiological study of randomized trials evaluating sodium-glucose cotransporter-2 inhibitors, glucagon-like peptide-1 receptor agonists, and non-steroidal mineralocorticoid receptor antagonists in adults with CKD. Female representation was quantified using the enrollment disparity difference (EDD), defined as the observed proportion of female trial participants minus the expected proportion derived from sex-specific Global Burden of Disease CKD prevalence estimates matched to trial population characteristics. Trial-level EDDs were pooled using random-effects meta-analysis. Meta-regression was used to examine trial-level correlates of EDD. Historical analyses extended the cohort to earlier cardiorenal pharmacotherapies to evaluate temporal trends, with pivotal CKD trials examined descriptively. Reporting of sex-specific cardiovascular and kidney outcomes was also assessed. [RESULTS] Fifty-five randomized trials were included. Median female enrollment was 33.1%, and 52 trials (94.5%) enrolled fewer women than expected. The pooled EDD was -0.17 (95% CI, -0.20; -0.14), with negative estimates across all intervention classes. In meta-regression, phase II design and albuminuria requirement were associated with greater female underrepresentation, whereas diabetes requirement and female first authorship were associated with smaller enrollment disparity, including after adjustment for other key trial characteristics. Sex-specific outcomes were reported in 13 trials (23.6%). Extension to 117 trials provided no statistically supported evidence of improvement in female representation over time, including after adjustment for intervention class; all 38 pivotal CKD trials enrolled fewer women than expected. [CONCLUSIONS] Women remain underrepresented in cardiorenoprotective therapy trials, with limited sex-specific outcome reporting. Historical benchmarking indicates that successive advances in CKD pharmacotherapy have not been accompanied by demonstrable improvement in the sex representativeness of the evidence base.