Abstract
Thrice-weekly hemodialysis (HD) is the most common treatment modality for kidney failure in the United States. We conducted a pilot study to assess the feasibility and safety of incremental-start HD in patients beginning maintenance HD. Pilot study. Adults with estimated glomerular filtration rate (eGFR)≥5 mL/min/1.73 m2 and urine volume≥500 mL/d beginning maintenance HD at 14 outpatient dialysis units. Randomized allocation (1:1 ratio) to twice-weekly HD and adjuvant pharmacologic therapy for 6 weeks followed by thrice-weekly HD (incremental HD group) or thrice-weekly HD (conventional HD group). The primary outcome was feasibility. Secondary outcomes included changes in urine volume and solute clearance. Of 77 patients invited to participate, 51 consented to do so, representing 66% of eligible patients. We randomized 23 patients to the incremental HD group and 25 patients to the conventional HD group. Protocol-based loop diuretics, sodium bicarbonate, and patiromer were prescribed to 100%, 39%, and 17% of patients on twice-weekly HD, respectively. At a mean follow-up of 281.9 days, participant adherence was 96% to the HD schedule (22 of 23 and 24 of 25 in the incremental and conventional groups, respectively) and 100% in both groups to serial timed urine collection. The incidence rate ratio for all-cause hospitalization was 0.31 (95% CI, 0.08-1.17); and 7 deaths were recorded (1 in the incremental and 6 in the conventional group). At week 24, the incremental HD group had lower declines in urine volume (a difference of 51.0 [95% CI,-0.7 to 102.8] percentage points) and in the averaged urea and creatinine clearances (a difference of 57.9 [95% CI,-22.6 to 138.4] percentage points). Small sample size, time-limited twice-weekly HD. It is feasible to enroll patients beginning maintenance HD into a randomized study of incremental-start HD with adjuvant pharmacotherapy who adhere to the study protocol during follow-up. Larger multicenter clinical trials are indicated to determine the efficacy and safety of incremental HD with longer twice-weekly HD periods. Funding was provided by Vifor Inc. Registered at ClinicalTrials.gov, identifier NCT03740048.
Highlights
Almost all Americans with kidney dysfunction requiring dialysis (KDRD) initiated on treatment with maintenance hemodialysis (HD) are prescribed standard dialytic therapy of fixed frequency and dose[1].This standard HD therapy disregards individual levels of residual kidney function[2, 3]
The conventional group received thrice-weekly hemodialysis (n=25). 41% of the patients met preliminary eligibility criteria; 66% consented; 96% adhered to protocol-defined frequency of hemodialysis treatments; and all adhered to protocol-defined timed urine collections
Incremental HD, i.e., twice-weekly HD at initiation of dialysis therapy, later switched to thrice-weekly HD according to changes in residual kidney function and/or other clinical indications, yielded adequate symptom control[9, 10]
Summary
Conclusions: It is feasible to enroll patients with incident KDRD into a randomized study of incremental-start HD with adjuvant pharmacotherapy who adhere to the study protocol during follow-up. Larger multicenter clinical trials are indicated to determine the efficacy and safety of incremental HD with longer twice-weekly HD periods. We performed a randomized pilot study to assess the feasibility of incremental-start hemodialysis in the incident hemodialysis population. The intervention group received twice-weekly hemodialysis with pharmacoadjuvant therapy for 6 weeks and changed to thrice-weekly hemodialysis (n=23). The conventional group received thrice-weekly hemodialysis (n=25). 41% of the patients met preliminary eligibility criteria; 66% consented; 96% adhered to protocol-defined frequency of hemodialysis treatments; and all adhered to protocol-defined timed urine collections. Larger multicenter clinical trials are indicated to determine the efficacy and safety of incremental hemodialysis with individualized periods of twice-weekly hemodialysis
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