Pilot Study of Loop Diuretics Among Individuals Receiving Hemodialysis

PHASE2CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

October 7, 2020

Primary Completion Date

June 8, 2021

Study Completion Date

June 22, 2021

Conditions
Chronic Kidney Disease Requiring Chronic Dialysis
Interventions
DRUG

Furosemide (loop diuretic) Tablets

Open label dose escalation study of furosemide in people receiving maintenance hemodialysis. Participants will take furosemide oral tablets twice daily for 18 weeks. Doses will be titrated every 2 weeks for 6 weeks if safe, effective, tolerated, and accepted by the participant. First 2 weeks of the study: participants not taking oral furosemide at enrollment will take 80mg furosemide twice daily, those taking oral furosemide at enrollment will stay on their prescribed dose, and those taking another loop diuretic at enrollment will discontinue their prescription and take an equivalent oral furosemide dose. At week 4: dose escalation if tolerated (from 80mg to 120mg twice daily for the 1st group, and a 50% increased dose not \>320mg/day for the 2nd \& 3rd groups). At week 6: dose escalation if tolerated (from 120mg to 160mg twice daily for the 1st group, and a 50% increased dose not \>320mg/day for the 2nd \& 3rd groups). Final 12 weeks: all participants will take the maximum tolerated dose.

Trial Locations (5)

27312

Carolina Dialysis - Pittsboro, Pittsboro

27330

Carolina Dialysis - Sanford, Sanford

27332

Carolina Dialysis - Lee County, Sanford

27344

Carolina Dialysis - Siler City, Siler City

27510

Carolina Dialysis - Carrboro, Carrboro

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

University of North Carolina, Chapel Hill

OTHER

NCT04622709 - Pilot Study of Loop Diuretics Among Individuals Receiving Hemodialysis | Biotech Hunter | Biotech Hunter