Recruiting

Incremental Hemodialysis

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05828823

Conditions

End-Stage Kidney Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hemodialysis twice weekly

Hemodialysis thrice weekly

Study Details

Brief summary:

This study is to prospectively compare clinical effectiveness between clinically- matched incremental hemodialysis and conventional hemodialysis in patients with incident kidney dysfunction requiring dialysis and residual kidney function.

The study will enroll 350 patients on chronic hemodialysis and 140 caregivers of enrolled patients. Patients will be randomized in 1:1 ratio to either incremental start hemodialysis or conventional hemodialysis. Caregivers will be followed along with patients for an average period of 2 years post randomization.

Conditions

End-Stage Kidney Disease

Study ID

NCT05828823

Start date

Feb 26, 2024

Status verified date

May, 2026

Completion date

Jan, 2031

Anticipated

Primary completion date

Jul, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Clinically-matched Incremental Hemodialysis ( CMIHD)

Randomized group to have hemodialysis prescription tailored based on residual kidney function and clinical manifestations starting at twice weekly.

active comparator: Conventional Hemodialysis (CHD)

Randomized group to conventional three times a week hemodialysis.

Interventions

Hemodialysis twice weekly

Frequency and duration of hemodialysis is tailored to the patient. Adjuvant pharmacotherapy is prescribed to maintain volume, electrolyte and acid-base homeostasis ( e.g., diuretics, sodium bicarbonate and potassium binding patiromer)

Hemodialysis thrice weekly

Conventional hemodialysis regimen

Primary outcome measure

  • Number of Clinical events of safety [ Time Frame: year 2 ]

Central Contacts and Locations

Central contacts

Brenda Burciu

336-716-8671Brindusa.Burciu@advocatehealth.org

Ben Bagwell

Benjamin.Bagwell@advocatehealth.org

Locations

University of Florida

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Alaa Awad, MD

Alaa.Awad@jax.ufl.edu

Principal Investigator:

Alaa Awad

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Vandana Dua Niyyar

vniyyar@emory.edu

Principal Investigator:

Vandana Dua Niyyar

Johns Hopkins University School of Medicine (JHUSM)

Recruiting

Baltimore, Maryland, United States, 21218

Principal Investigator:

Gautam Samir, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Sagar Nigwekar

617-726-5050SNIGWEKAR@mgh.harvard.edu

Principal Investigator:

Sagar Nigwekar

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Neville Dossabhoy, MD

601-984-5670ndossabhoy@umc.edu

Principal Investigator:

Neville Dossabhoy, MD

Renal Research Institute (RRI)

Recruiting

New York, New York, United States, 10065

Contacts

Rasha Hussein, MD

212-331-1710rasha.hussein@rriny.com

Principal Investigator:

Rasha Hussein, MD

Northwell Health

Recruiting

Queens, New York, United States, 11427

Contacts

Steven Fishbane

516-465-8200Sfishbane@northwell.edu

Principal Investigator:

Steven Fishbane

University of North Carolina Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Principal Investigator:

Jennifer Flythe, MD

Atrium Health Wake Forest Baptist

Recruiting

Winston-Salem, North Carolina, United States, 27157

Principal Investigator:

Mariana Murea, MD

University of Virginia (UVA)

Recruiting

Charlottesville, Virginia, United States, 22904

Principal Investigator:

Emaad Abdel-Rahman, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Aug 6, 2026

Last verified

May, 2026

Keywords

  • Hemodialysis
  • Clinically-Matched Incremental Hemodialysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-08-06.