Comparative Effectiveness of an Individualized Model of Hemodialysis Versus Conventional Hemodialysis

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
University of Florida
RECRUITING
Jacksonville
Georgia
Emory University
RECRUITING
Atlanta
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Johns Hopkins University School of Medicine (JHUSM)
RECRUITING
Baltimore
North Carolina
University of North Carolina Chapel Hill
RECRUITING
Chapel Hill
Atrium Health Wake Forest Baptist
RECRUITING
Winston-salem
New York
Renal Research Institute (RRI)
RECRUITING
New York
Northwell Health
RECRUITING
Queens
Ohio
Cleveland Clinic, Case Western Reserve University (CWRU)
RECRUITING
Cleveland
Virginia
University of Virginia (UVA)
RECRUITING
Charlottesville
Contact Information
Primary
Denisse A Funes
dfunes@wakehealth.edu
336-716-8671
Backup
Brindusa Burciu
bburciu@wakehealth.edu
3367168671
Time Frame
Start Date: 2024-02-26
Estimated Completion Date: 2028-03
Participants
Target number of participants: 350
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Wake Forest University Health Sciences
Collaborators: Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov