Background: Effective fluid management is critical for improving outcomes in patients undergoing chronic hemodialysis (HD). Relative blood volume monitoring (RBVM) supports the optimization of ultrafiltration rate adjustments; however, real-world evidence evaluating its impact on hospitalizations in chronic HD is limited. Methods: We conducted a retrospective, propensity score-matched observational cohort study comparing patient outcomes across 165 Fresenius Kidney Care clinics with high RBVM utilization (HI-RBVM; >90% of treatments) matched to 165 clinics not using RBVM (NO-RBVM). Data were collected from July to December 2022. Primary outcomes were patient-level all-cause and fluid-related hospitalizations and hospitalization days over a 6-month follow-up. Multivariable scaled Poisson regression models were used to estimate adjusted incidence rates, rate ratios, and rate differences. Secondary outcomes included patient-level changes in monthly clinical measurements. Results: 24,958 patients were included (11,840 across HI-RBVM clinics; 13,118 across NO-RBVM clinics). Adjusted incidence rates were lower in the HI-RBVM group compared to the NO-RBVM group for all-cause hospitalizations (1.57 vs. 1.70 per person-year [ppy]), fluid-related hospitalizations (0.30 vs. 0.35 ppy), and hospitalization days (9.60 vs. 10.8 ppy), corresponding to 119 fewer hospital days per 100 patient-years (95% CI: -184, -54; p < 0.001). Among patients with dialysis vintage ≤6 months, those treated in HI-RBVM clinics had smaller increases in pre-HD weight (-0.03 kg vs. +0.46 kg; p = 0.008) and ultrafiltration volume (0.11 L vs. 0.21 L; p = 0.004), and underwent more frequent estimated dry weight (EDW) adjustments (mean 7.73 vs. 6.61; p < 0.001). Conclusions: Among HD patients, high RBVM utilization at the clinic level was associated with lower rates of hospitalization. Prospective or quasi-experimental studies are needed to determine causality.
Hyperkalemia is a common and potentially life-threatening complication among patients receiving maintenance hemodialysis (HD). Patiromer (Veltassa®) is an oral potassium binder with established potassium control efficacy in chronic kidney disease, but evidence in HD patients remains limited. We conducted a retrospective, single-arm, cohort study of adult patients (n = 10,860) receiving in-center HD at Fresenius Kidney Care clinics who initiated patiromer between 2016 and 2022, comparing outcomes before (baseline: 3 months prior to initiation) and after initiation (up to 12 months of follow-up). Outcomes included changes in serum potassium (sK), treatment schedules, dosing patterns, and hospitalizations. At baseline, mean age was 60 years, 58
Chronic kidney disease–associated pruritus (CKD-aP) can negatively impact quality of life and survival among patients receiving maintenance hemodialysis. Difelikefalin, a selective κ-opioid receptor agonist, is the first medication approved for treatment of moderate-to-severe CKD-aP among patients on chronic hemodialysis. This retrospective database study assessed the real-world safety and effectiveness of difelikefalin across a large US dialysis organization. We analyzed de-identified data from 715 adult hemodialysis patients treated with difelikefalin who had a Worst Itching Intensity Numerical Rating Scale (WI-NRS) score (0 = no itching to 10 = worst itch imaginable) assessed before therapy. Patients were classified as having received at least 30 difelikefalin doses over 12 weeks (complete regimen group; CRG) or fewer doses over that time period (incomplete regimen group; IRG). Mean baseline and follow-up WI-NRS scores were compared and potential adverse events evaluated. Mean (SD) baseline WI-NRS scores were 8.5 (1.7), indicative of severe pruritic symptomatology. In the 22
Rationale & Objective:Chronic kidney disease-associated pruritus is commonly related to reduced health-related quality of life, decreased adherence to dialysis, and increased mortality, yet it remains underrecognized and underdiagnosed. We conducted an analysis to characterize the relationship between pruritus and a recognized symptom cluster among hemodialysis patients. Study Design:This retrospective study of adults receiving hemodialysis in a large US dialysis organization analyzed pruritus and the individual symptoms of sleep disturbance, depression, pain, anxiety, and low energy/fatigue. Data from the Kidney Disease Quality of Life 36-Item Short Form Survey (KDQOL-36) and the Patient Health Questionnaire-2 were extracted from electronic medical records. Results:Of the 243,168 adults receiving hemodialysis during the study period who completed a KDQOL-36, 47,477 reported at least moderate bother from pruritus. An additional randomly sampled 33,833 adults not reporting at least moderate pruritus were also included. The KDQOL-36 ratings for each symptom (sleep disturbance, depression, pain, anxiety, and low energy/fatigue) exhibited a significantly (P < 0.001) greater burden with increased pruritus severity. Similar results were observed for KDQOL-36 summary scores. Extreme pruritus was associated with greater than 5-fold and 3-fold increased risk of depressive symptoms and sleep disturbance, respectively. Pruritus was also independently associated with Patient Health Questionnaire-2-defined depressive symptoms. The association of pruritus with co-occurring symptoms was demonstrated across all serum phosphorus concentration subgroups. Patients reporting higher degrees of bother from pruritus were significantly more likely to miss multiple hemodialysis sessions or have shortened treatment sessions. Limitations:The cross-sectional nature of the study limits exploration of temporal relationships between the symptoms. Conclusions:Among hemodialysis patients, pruritus is commonly reported and associated with reduced health-related quality of life. It should be considered alongside the following symptoms commonly observed: sleep disturbance, depression, pain, anxiety, and low energy/fatigue. The presence of one symptom should prompt further investigation, allowing for appropriate diagnosis and management.
Abstract Background and Aims Chronic kidney disease associated pruritis (CKD-aP) is a common disorder that negatively impacts a patient's quality of life. Itch can be self-reported using the Worst Itching Intensity Numerical Rating Scale (WI-NRS) where higher numbers indicate more severe itch. Difelikefalin (DFK) has been shown to reduce itch in hemodialysis (HD) patients with moderate to severe CKD-aP in clinical trials. Previously, we reported the real-world results of patients who completed 12 weeks of DFK treatment as part of routine clinical care. This current analysis describes the long-term treatment of these 295 patients. Method Fresenius Kidney Care (FKC) in-center HD patients aged 18-89 who received at least 1 dose of DFK before 15 Nov 2022 and were administered a WI-NRS before first DFK administration were assessed. Patients who received 30+ DFK administrations within 74-84 days were classified as complete and are the focus of this analysis. The current analysis focuses on the 3- to 12-month follow-up after first DFK administration to monitor for DFK discontinuation and severity of itch when DKF therapy is discontinued. Results Eighty-one percent of patients (238/295) were administered DFK doses beyond 90 days. These patients treated included 167 patients who received DFK continuously (doses between days 91-101) and 71 who restarted DFK after day 101. Most patients (62%, 148/238) were treated with DKF between days 354 and 365 and 90 (38%, 90/238) stopped before 354 days. Out of those not treated with DFK beyond 90 days (19%, 57/295), 26 patients died or were transferred outside of FKC and 1 received a kidney transplant. Out of the 84 patients previously reported with WI-NRS measured before DFK and during DFK WI-NRS, 29 had follow up WI-NRS scores during times without DFK doses. We observed a decrease in mean itch severity from 8.0 before DFK to 3.2 during DFK and then a return to higher itch severity after DFK was discontinued (7.3). Conclusion In a real-world analysis of patients who completed 12 weeks of DFK therapy, 81% of patients received further DKF administrations. Most patients were treated with DFK between days 354 and 365, although not all patients received continuous DFK therapy. In a subset 29 patients with WI-NRS scores before DFK, during DFK, and after discontinuation, improvements in itch were noted during DFK treatment and a return to severe itch after DFK discontinuation.
Key Points This is the largest analysis of incident automated peritoneal dialysis (PD) prescriptions conducted in the United States to date. There was limited variability of automated PD prescriptions across the first 4 months of therapy. PD prescriptions tailored to meet the dialysis needs and lifestyle of patients may make PD a more attractive choice and increase longevity on PD. Background Changes in health care policies and recognition of patient benefit have contributed to increases in home-based dialysis, including peritoneal dialysis (PD). Frequent monitoring and early individualization of PD prescriptions are key prerequisites for the delivery of high-quality PD. The present analysis aimed to assess variations in PD prescriptions among incident automated PD (APD) patients who remain on PD for 120+ days. Methods This retrospective analysis examined data from patients within a large dialysis organization that initiated PD with APD between 2015 and 2019. PD prescription data were described by calendar year, timing of PD, and residual renal function categories. Changes in prescriptions from PD initiation (day 1) to day 120 were assessed descriptively. Results The cohort included 11,659 patients. The mean age at PD initiation increased from 2015 (56 [15] years) through 2019 (58 [15] years), whereas most other variables demonstrated no clear temporal change. Most patients (86%) had nighttime PD prescribed, with an average of 4.9 (1.3) cycles per day, a mean total treatment volume of 9.3 (2.5) L, and a median daily total dwell time of 7 (6–9.5) hours. Relative to day 1 nighttime prescriptions, there were ( 1 ) small increases in the proportion of patients receiving three or fewer cycles per day and those receiving 6+ cycles per day, ( 2 ) a 100 ml mean increase in fill volume per exchange, and ( 3 ) a mean 0.5 L increase in total nighttime treatment volume at day 120. When changes in nighttime APD prescriptions were examined at the patient level, 49% of patients had day 120 prescriptions that were unchanged from their initial prescription. Conclusions In the largest analysis of incident APD prescriptions conducted in the United States to date, most patients were prescribed nocturnal PD only with limited variability across the first 4 months of therapy.
Abstract Background Hyperphosphatemia is associated with increased morbidity and mortality in patients with end-stage kidney disease (ESKD). Whereas clinical and observational studies have demonstrated the effectiveness of sucroferric oxyhydroxide (SO) in controlling serum phosphorus (sP) in ESKD, data on the real-world impact of switching to SO in patients on peritoneal dialysis (PD) are limited. In this retrospective database analysis, we examine the impact of SO on sP management over a 1-year period among PD patients prescribed SO as part of routine clinical care. Methods We analyzed de-identified data from adults on PD in Fresenius Kidney Care clinics who were prescribed SO monotherapy between May 2018 and December 2019 as part of routine clinical management. Changes from baseline in sP levels, phosphate binder (PB) pill burden, and laboratory parameters were evaluated during the four consecutive 91-day intervals of SO treatment. Results The mean age of the 402 patients who completed 1 year of SO was 55.2 years at baseline, and they had been on PD for an average of 19.9 months. SO was initiated with no baseline PB recorded in 36.1% of patients, whereas the remaining 257 patients were switched to SO from sevelamer (39.7%), calcium acetate (30.4%), lanthanum (1.2%), ferric citrate (14.0%), or more than one PB (14.8%). Mean sP at baseline was 6.26 mg/dL. After being prescribed SO, the percentage of patients achieving sP ≤ 5.5 mg/dL increased from 32.1% (baseline) to 46.5–54.0% during the 1-year follow-up, whereas the mean number of PB pills taken per day decreased from 7.7 at baseline (among patients on a baseline PB) to 4.6 to 5.4. Serum phosphorus and PB pill burden decreased regardless of changes in residual kidney function over the 12-month period. Similar results were observed for the full cohort (976 patients who either completed or discontinued SO during the 1-year follow-up). Conclusions Patients on PD who were prescribed SO as part of routine care for phosphorus management experienced significant reductions in SP and PB pills per day and improvements in sP target achievement, suggesting the effectiveness of SO on SP management with a concurrent reduction in pill burden.