Incremental Hemodialysis: The TwoPlus Trial

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT05828823
Status
Recruiting
Apply to this trial

Conditions

  • End-Stage Kidney Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hemodialysis twice weekly — DEVICE
    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 — OTHER
    Conventional hemodialysis regimen

Study Details

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.

Key Dates

Start date
Feb 26, 2024
Status verified
May 2026
Primary completion
Jul 31, 2030
Completion
Jan 31, 2031

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
University of FloridaJacksonvilleFlorida32209
Alaa Awad, MD
[email protected]
Alaa Awad (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30322
Vandana Dua Niyyar
[email protected]
Vandana Dua Niyyar (PRINCIPAL_INVESTIGATOR)
Johns Hopkins University School of Medicine (JHUSM)BaltimoreMaryland21218
Gautam Samir, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Sagar Nigwekar
[email protected]
617-726-5050
Sagar Nigwekar (PRINCIPAL_INVESTIGATOR)
University of Mississippi Medical CenterJacksonMississippi39216
Neville Dossabhoy, MD
[email protected]
601-984-5670
Neville Dossabhoy, MD (PRINCIPAL_INVESTIGATOR)
Renal Research Institute (RRI)New YorkNew York10065
Rasha Hussein, MD
[email protected]
212-331-1710
Rasha Hussein, MD (PRINCIPAL_INVESTIGATOR)
Northwell HealthQueensNew York11427
Steven Fishbane
[email protected]
516-465-8200
Steven Fishbane (PRINCIPAL_INVESTIGATOR)
University of North Carolina Chapel HillChapel HillNorth Carolina27599
Jennifer Flythe, MD (PRINCIPAL_INVESTIGATOR)
Atrium Health Wake Forest BaptistWinston-SalemNorth Carolina27157
Mariana Murea, MD (PRINCIPAL_INVESTIGATOR)
University of Virginia (UVA)CharlottesvilleVirginia22904
Emaad Abdel-Rahman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Jacksonville, FL

By research site
University of Florida· Jacksonville, FLEmory University· Atlanta, GAJohns Hopkins University School of Medicine (JHUSM)· Baltimore, MDMassachusetts General Hospital· Boston, MAUniversity of Mississippi Medical Center· Jackson, MSRenal Research Institute (RRI)· New York, NY

Related Studies