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Abstract: FR-PO428

Dialyzer Performance and Associations in Self-Reported Pruritis and Fatigue: 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
  • Krizsan, Maria, FMC, Péterfy II. Dialízis Központ, Budapest, Hungary
  • Ronova, Petra, Fresenius Nephrocare Praha 9 - Vysocany, Praha, Czechia
  • 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 multi-center crossover trial with 4-week randomized treatment periods comparing dialyzer performance (FX CorAL 600 vs two comparable high-flux dialyzers) in post-dilution online hemodiafiltration (HDF). Primary outcome was beta-2 microglobulin (B2M) removal and self-reported itching and fatigue were also studied.

Methods

Adults on HDF were recruited from 8 centers in Europe (NCT04714281). B2M removal rate (B2M RR) 0 vs 240 min was measured in week 3 (mid-week) of each period. Pruritus Numerical Rating Scale (PNRS) & KDQOL-SF fatigue domain (questions 9a, e, g & i) were captured at baseline & end of periods. Peak/average PNRS surveys capture the worst/average itch in the prior 24 hours on a 0 (no itch) to 10 (worst itch imaginable) point scale. Fatigue survey captures the energy level in the last month on a 0 (least energy) to 100 (most energy) point scale. Analysis used mixed effects model adjusted for center and patient.

Results

Trial enrolled 82 subjects (76 ITT group, mean age 67.0±15.6 years, 26.3% female, 34.2% diabetes). FX CorAL 600 showed a +0.60±0.39% and +1.82±0.38% higher B2M RR vs FX CorDiax 600 (non-inferiority p<0.0001; superiority p=0.0606) and xevonta Hi 15 (non-inferiority p<0.0001; superiority p<0.0001). Mean peak PNRS score was 1.0±1.94, and fatigue score was 63.8±21.41 (Figure 1). FX CorAL 600 showed a -0.08 and +0.08 point change in peak PNRS scores vs FX CorDiax 600 (p=0.66) and xevonta Hi 15 (p=0.65); consistent findings were seen for average NRS scores. FX CorAL 600 showed a -0.01 and +0.30 point change in fatigue scores vs FX CorDiax 600 (p=0.95) and xevonta Hi 15 (p=0.86).

Conclusion

FX CorAL 600 provides a higher B2M RR than the comparators. PNRS & fatigue scores were consistent between dialyzer types. Total PNRS & fatigue values indicate mild-to-no itching and reasonable vitality among participants. Nonetheless, some unique patients reported severe itching and fatigue symptoms. Higher middle molecule clearance may not affect these outcomes. However, more studies are needed with longer follow-up should consider focusing on patients with remarkable symptoms.

Funding

  • Commercial Support – Fresenius Medical Care