Incremental Hemodialysis: The TwoPlus Trial

Wake Forest University (WFU)

Status: Enrolling

Conditions: End-Stage Kidney Disease

Treatments: Device: Hemodialysis twice weekly; Other: Hemodialysis thrice weekly

Study type: Interventional

Funder types: Other

Identifiers

NCT05828823

IRB00092986

CER-2022C1-26300 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Clinically-matched Incremental Hemodialysis ( CMIHD)

Experimental group

Description:

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

Treatment:

Device: Hemodialysis twice weekly

Conventional Hemodialysis (CHD)

Active Comparator group

Description:

Randomized group to conventional three times a week hemodialysis.

Treatment:

Other: Hemodialysis thrice weekly