Project Summary
What is the research about?
Patients with advanced kidney disease who start hemodialysis (HD) are conventionally offered kidney replacement therapy with three HD treatments per week. The current prescription of HD is based on previous studies that solely included patients with minimal or no residual kidney function. However, many patients have residual kidney function when they begin HD and might not need the same dose of HD as those who have no residual kidney function. For patients started on HD who also have residual kidney function, three HD treatments per week can be unnecessarily burdensome, stressful, or even harmful. Therefore, patients with residual kidney function may benefit from starting with a less frequent HD regimen, or kidney assistance therapy. The study team’s hypothesis is that for these patients, incremental introduction of HD matched to their condition (i.e., clinically matched) will be as effective and yet less intrusive than the current conventional HD regimen. Clinically matched incremental HD would begin with two treatments per week plus drugs that enhance kidney function, transitioning to three HD treatments per week when residual kidney function worsens or clinical condition warrants. This individualized HD treatment model will be implemented across seven national Healthcare Systems as a participatory intervention, i.e., intervention with active participation from treating providers and dialysis personnel.
What is the research team doing?
Over a two-year period, the study team will enroll 350 eligible patients who are starting HD and 140 caregivers. Patients will be randomly assigned to either clinically matched incremental HD or conventional HD. The study team will analyze 24-hour urine collections to monitor residual kidney function. Patients on two HD treatments per week will transition to three HD treatments per week when kidney residual levels have weakened or clinical symptoms benefit from additional HD treatments. The study team will compare clinical safety (emergency department visits, hospitalizations, and death); patient- and caregiver-reported health-related quality of life; and other clinical outcomes between groups. Participation of dialysis stakeholders in this study will allow for the to evaluation of factors needed to implement individualized HD at outpatient dialysis centers.
How will patients and stakeholders make this project successful?
The study team will collaborate with stakeholders (treating providers, dialysis nurses, dialysis dietitians, and dialysis social workers) to seamlessly incorporate the study into daily workflows. Feedback on processes of care will be obtained from Stakeholder Advisory Panels of patient and caregiver participants, treating providers, and dialysis personnel at all participating centers. Stakeholder feedback from surveys and interviews will inform implementation of clinically matched incremental HD as a participatory, partnered, and dynamic intervention. Trusted patient advocacy organizations will help share results with the broader community.
Who can this research help?
This study will expand options for patients who need HD by generating evidence for an individualized HD treatment model. Results will help patients, caregivers, and providers decide about the best HD treatment option. It is anticipated that providing the proposed kidney assistance therapy to those who are eligible will prove safe and improve patients’ and caregivers’ quality of life.
Why is this study important to patients?
(1) Kidney disease is one of the fastest-growing medical conditions, the 10th leading cause of death worldwide, and responsible for higher rates of disability-adjusted life years than that for heart disease or drug use.
(2) Current, undifferentiated care with conventional HD was based on research in patients with no residual kidney function, even though at least 25% of patients harbor residual kidney function when HD is added to their medical care.
(3) Research shows that an incremental HD treatment plan (two HD treatments per week and then three HD treatments per week) is safe and effective in patients with residual kidney function, has the potential to reduce HD treatment-related burden for patients, and is endorsed by clinical guidelines across the globe. Yet, patients are not receiving differentiated care owing to lack of clinical trials comparing the effectiveness of incremental and conventional HD. This work will fill this gap of knowledge, eliminate “one-size-fits-all” patient care, and broaden HD treatment options.