Comparing Incremental Hemodialysis to Conventional Hemodialysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Mariana Murea, MD — Wake Forest Health Sciences
• Study coordinator: Brenda Burciu
• Email: Brindusa.Burciu@advocatehealth.org
• Phone: 336-716-8671

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.