Comparing Incremental Hemodialysis to Conventional Hemodialysis
Comparative Effectiveness of an Individualized Model of Hemodialysis Versus Conventional Hemodialysis
This study is testing if a new way of doing hemodialysis called incremental hemodialysis can help people with end-stage kidney disease feel better and have fewer hospital visits compared to the standard method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 10 sites (Jacksonville, Florida and 9 other locations) |
| Trial ID | NCT05828823 on ClinicalTrials.gov |
What this trial studies
This study aims to prospectively compare the clinical effectiveness of clinically-matched incremental hemodialysis against conventional hemodialysis in patients with end-stage kidney disease requiring dialysis. It will enroll 350 patients and 140 caregivers, randomizing participants to receive either incremental or conventional hemodialysis. The study will assess various outcomes, including survival, hospitalization rates, preservation of kidney function, and quality of life over an average follow-up period of two years. The focus is on individualized care to improve patient health and reduce caregiver burden.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with incident kidney dysfunction requiring dialysis and some residual kidney function.
Not a fit: Patients with severe electrolyte imbalances or those requiring high-volume ultrafiltration may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the quality of life and health outcomes for patients undergoing hemodialysis.
How similar studies have performed: Other studies have shown promise in individualized hemodialysis approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Patient eligibility Criteria: Inclusion Criteria: * Clinical Inclusion Criteria: * Age ≥ 18 years * Incident kidney dysfunction requiring dialysis (KDRD) started on maintenance, in-center hemodialysis (HD), or anticipated to be started on maintenance, in-center HD within the next 12 weeks * Has received ≤36 sessions of intermittent HD (i.e., on HD for ≤12 weeks) at the time patient is approached for potential study participation Residual Kidney Function Inclusion Criteria: * Kidney urea clearance \<2.0 mL/min * Urine volume# of ≥500 mL/24 h Exclusion Criteria: * Pre-HD serum K ≥5.8 mEq/L, Na ≤125 mEq/L, or bicarbonate level ≤17 mEq/L * Requirement or anticipated requirement of high-volume ultrafiltration * Unable or unwilling to follow the study protocol for any reason * Known pregnancy or planning to attempt to become pregnant or lactating women * Estimated survival or dialysis modality change or center transfer \<6 months Caregiver Eligibility Criteria: * be at least 18 years old * be the main caregiver (at patient's choice) * be a close relative of the patient (spouse, child, sibling, parent, grandchild) * have no known psychiatric and neurologic disorders (through direct inquiry from the person) * not be a member of the medical or healthcare team * not be the caregiver for another patient with chronic illness * not have experienced severe life events within prior 3 months of enrollment (through direct inquiry from the person)
Where this trial is running
Jacksonville, Florida and 9 other locations
- University of Florida — Jacksonville, Florida, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Johns Hopkins University School of Medicine (JHUSM) — Baltimore, Maryland, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Mississippi Medical Center — Jackson, Mississippi, United States (Recruiting)
- Renal Research Institute (RRI) — New York, New York, United States (Recruiting)
- Northwell Health — Queens, New York, United States (Recruiting)
- University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (Recruiting)
- University of Virginia (UVA) — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Mariana Murea, MD — Wake Forest Health Sciences
- Study coordinator: Brenda Burciu
- Email: Brindusa.Burciu@advocatehealth.org
- Phone: 336-716-8671
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.