200
Participants
Start Date
March 11, 2024
Primary Completion Date
April 1, 2026
Study Completion Date
July 1, 2026
IVIG (intravenous immunoglobulin)
Participants will receive IVIG for 9 months (36 weeks) with a follow-up period for an additional 3 months (total study duration for 12 months).
IVIG Placebo
"Normal saline given intravenously will be the control (placebo) product. Blinding IV bag and tubing covers will be used for both IVIG and Placebo.~Participants will receive placebo for 9 months (36 weeks) with a follow-up period for an additional 3 months (total study duration for 12 months)."
Coordinated Care
Participants will receive coordinated non-pharmacologic care for a duration of 3 months, concurrent with IVIG administration. Coordinated non-pharmacologic care involves volume expansion through high salt diet, water intake, abdominal binder, exercise/rehabilitation, motivation, education, and assisted care through care coordinator.
Usual Care
Participants will receive usual non-pharmacologic care (control) for a duration of 3 months, concurrent with IVIG administration.
All sites listed under NCT06305780, Durham
Kanecia Obie Zimmerman
OTHER