Clinical trial NCT05828823: Incremental Hemodialysis: The TwoPlus Trial
Official title: Comparative Effectiveness of an Individualized Model of Hemodialysis Versus Conventional Hemodialysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End-Stage Kidney Disease
Keywords: Hemodialysis
Clinically-Matched Incremental Hemodialysis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2023-04-25
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized parallel-group type 1 hybrid study
Primary purpose: TREATMENT

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.

Detailed description: This study will analyze the effects of differentiated care with individualized hemodialysis on patient health related quality of life, fatigue, employment, and caregiver burden in patients with Kidney dysfunction requiring dialysis (KDRD) and appreciable kidney function.

This study will compare the outcomes in survival, hospitalization, preservation of the kidney function and quality of life between hemodialysis tailored to each patient needs (incremental) and conventional hemodialysis.

Eligibility 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)

Primary outcomes:
measure: Number of Clinical events of safety
timeFrame: year 2
Secondary outcomes:
measure: EuroQOL-5D-5L scores Health-related quality of life Health-related quality of life and residual kidney function
timeFrame: year 2
measure: Trail Making Test B scores Health-related quality of life Health-related quality of life and residual kidney function
timeFrame: Baseline and months 6, 12, 18, & 24
measure: Standardized Outcomes in Nephrology (SONG) scores Health-related quality of life Health-related quality of life and residual kidney function
timeFrame: Baseline and months 6, 12, 18, & 24
measure: Time to recover from hemodialysis (HD) Health-related quality of life Health-related quality of life and residual kidney function
timeFrame: Baseline and monthly up to 2 years
measure: Caregiver burden Zarit Caregiver Burden Scores Health-related quality of life Health-related quality of life and residual kidney function
timeFrame: Baseline, months 6, 12, 18, & 24
measure: Change in urine output
timeFrame: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, and Year 2
measure: Change in kidney urea clearance (mL/min/1.73 m2)
timeFrame: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, and Year 2
measure: Change in kidney creatinine clearance (mL/min/1.73 m2)
timeFrame: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, and Year 2
measure: Hospital free days per 100 patient-days
timeFrame: year 2
measure: Illness Intrusiveness Rating Scale
timeFrame: Assessed at baseline and monthly up to 2 years
measure: Employment status
timeFrame: Baseline and months 6, 12, 18 and 24
Other outcomes:
measure: Characterize implementation processes using mixed methods - Intervention characteristics
timeFrame: 2 years
measure: Characterize implementation processes using mixed methods - Inner setting characteristics, to assess barriers and facilitators to the adoption of HD intervention at the partnering organizations
timeFrame: 2 years
measure: Characterize implementation processes using mixed methods - External factors that mediate implementation
timeFrame: 2 years
measure: Characterize implementation processes using mixed methods - Adoption
timeFrame: 2 years
measure: Characterize implementation processes using mixed methods - Reach
timeFrame: 2 years
measure: Characterize implementation processes using mixed methods - Fidelity, to assess adherence to serial timed urine collection and HD treatment schedule
timeFrame: 2 years
measure: Characterize implementation processes using mixed methods - Sustainability, to assess barriers and facilitators to maintaining intervention
timeFrame: 2 years
Locations:
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine (JHUSM)
state: Maryland
city: New York
country: United States
facility: Renal Research Institute (RRI)
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic, Case Western Reserve University (CWRU)
state: Ohio
city: Charlottesville
country: United States
facility: University of Virginia (UVA)
state: Virginia
Study officials:
affiliation: Wake Forest Health Sciences
name: Mariana Murea, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Renal Research Institute
name: Peter Kotanko
role: PRINCIPAL_INVESTIGATOR
References: