BridgeMD
New treatment option for End-Stage Kidney Disease
Official title Incremental Hemodialysis: The TwoPlus Trial
ClinicalTrials.gov ID: NCT05828823
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient eligibility Criteria:
- Clinical
- Age ≥ 18 years
- Incident kidney dysfunction requiring dialysis (KDRD) started on maintenance, in-center hemodialysis (HD), or anticipated to be started on...
- 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...
You likely can't join if
- 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
See the full eligibility criteria
- Patient eligibility Criteria:
- Clinical
- 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
- Kidney urea clearance \<2.0 mL/min
- Urine volume# of ≥500 mL/24 h
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
- Atlanta, Georgia, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Jackson, Mississippi, United States
- New York, New York, United States
- Queens, New York, United States
- Chapel Hill, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States; Atlanta, Georgia, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; Jackson, Mississippi, United States; New York, New York, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.