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Kidney Week

Abstract: FR-PO429

Clinical Performance and Patient-Reported Sleep Quality Associated with Dialyzer Types: Results from the eMPORA III Trial

Session Information

Category: Dialysis

  • 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Larkin, John W., Fresenius Medical Care, Waltham, Massachusetts, United States
  • Griesshaber, Bettina, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
  • Erlenkoetter, Ansgar, Fresenius Medical Care Deutschland GmbH Werk Sankt Wendel, Sankt Wendel, Saarland, Germany
  • Ronova, Petra, Fresenius Nephrocare Praha 9 - Vysocany, Prague, Czechia
  • Krizsan, Maria, FMC, Péterfy II. Dialízis Központ, Budapest, Hungary
  • Braun, Jennifer, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
  • Stauss-Grabo, Manuela, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
Background

eMPORA III was a prospective, multi-center, open, crossover trial with 4-week randomized treatment sequences comparing the clinical performance and hemocompatibility of dialyzers (FX CorAL 600 vs FX CorDiax 600 and xevonta Hi 15) in post-dilution online hemodiafiltration (HDF). Primary outcome of beta-2 microglobulin (B2M) removal showed FX CorAL 600 was non-inferior vs its comparators and superior vs. xevonta Hi 15. We assessed the additional patient-reported outcomes on sleep quality per Pittsburgh Sleep Quality Index (PSQI).

Methods

We recruited clinically stable adults on HDF from 8 centers in Europe (NCT04714281). PSQI was measured at baseline and at the end of each 4-week treatment sequence. PSQI survey assesses impairment of sleep quality in the prior month on a 0 (worst) to 21 (best) point scale and has 7 component subscales. PSQI scores >5 points show poor sleep quality. A linear mixed model adjusted for random effects of the center and patient estimated the effect of the dialyzer on PSQI scores.

Results

Study enrolled 82 subjects (76 in the ITT group, mean age 67.0±15.6 years, 26.3% female, 34.2% diabetes). Mean total PSQI score was 5.7±3.77 (Figure 1). FX CorAL 600 showed a -0.07 and -0.02 point lower PSQI scores vs FX CorDiax 600 (p=0.75) and xevonta Hi 15 (p=0.93). The 7 PSQI component scores showed consistent patterns with the total score, no differences by dialyzer.

Conclusion

PSQI scores were consistent between dialyzers. Total PSQI values indicate borderline poor sleep quality among trial participants; this appeared to be driven by small additive disturbances in all domains of component scores, especially for subjective sleep quality, latency, duration, and disturbances. FX CorAL 600 has previously shown higher B2M removal vs. comparators. Higher middle molecule clearance may not affect sleep quality outcomes, yet further studies are needed with longer follow-up times and could consider severity of symptoms (i.e., need for improvement).

Funding

  • Commercial Support – Fresenius Medical Care