Representation of Real-World Adults With Chronic Kidney Disease in Clinical Trials Supporting Blood Pressure Treatment Targets

Abstract

Background: Little is known about how well trial participants with chronic kidney disease (CKD) represent real-world adults with CKD. We assessed the population representativeness of clinical trials supporting the 2021 Kidney Disease: Improving Global Outcomes blood pressure (BP) guidelines in real-world adults with CKD.

Methods and results: Using a cross-sectional analysis, we identified patients with CKD who met the guideline definition of hypertension based on use of antihypertensive medications or sustained systolic BP ≥120 mm Hg in 2019 in the Veterans Affairs and Kaiser Permanente of Southern California. We applied the eligibility criteria from 3 BP target trials, SPRINT (Systolic Pressure Intervention Trial), ACCORD (Action to Control Cardiovascular Risk in Diabetes), and AASK (African American Study of Kidney Disease), to estimate the proportion of adults with a systolic BP above the guideline-recommended target and the proportion who met eligibility criteria for ≥1 trial. We identified 503 480 adults in the Veterans Affairs and 73 412 adults in Kaiser Permanente of Southern California with CKD and hypertension in 2019. We estimated 79.7% in the Veterans Affairs and 87.3% in the Kaiser Permanente of Southern California populations had a systolic BP ≥120 mm Hg; only 23.8% [23.7%-24.0%] in the Veterans Affairs and 20.8% [20.5%-21.1%] in Kaiser Permanente of Southern California were trial-eligible. Among trial-ineligible patients, >50% met >1 exclusion criteria.

Conclusions: Major BP target trials were representative of fewer than 1 in 4 real-world adults with CKD and hypertension. A large proportion of adults who are at risk for cardiovascular morbidity from hypertension and susceptible to adverse treatment effects lack relevant treatment information.

Keywords: blood pressure guidelines; chronic kidney disease; clinical trials; hypertension.

Figure 1. Butterfly plot of trial representativeness by age group among adults with hypertension and CKD in the 2019 VA and KPSC cohorts.

CKD indicates chronic kidney disease; KPSC, Kaiser Permanente Southern California; and VA, Veterans Affairs.

Figure 2. Butterfly plot of trial representativeness by race and ethnicity among adults with hypertension and CKD in the 2019 VA and KPSC cohorts.

CKD indicates chronic kidney disease; KPSC, Kaiser Permanente Southern California; and VA, Veterans Affairs.

Figure 3. Butterfly plot of trial representativeness by eGFR (mL/min per 1.73 m²) among adults with hypertension and CKD in the 2019 VA and KPSC cohorts.

CKD indicates chronic kidney disease; eGFR, estimated glomerular filtration rate; KPSC, Kaiser Permanente Southern California; and VA, Veterans Affairs.