Phase 2
N=39
Pilot Study of Loop Diuretics Among Individuals Receiving Hemodialysis
Chronic Kidney Disease Requiring Chronic Dialysis
Bottom Line
View on ClinicalTrials.gov: NCT04622709 ↗Enrolled (actual)
39
Serious AEs
20.5%
Results posted
Jun 2022
Primary outcome: Primary: Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 5 — 33 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Furosemide (loop diuretic) Tablets (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 5 |
33 | — |
| PRIMARY Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 12 |
33 | — |
| PRIMARY Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 18 |
22 | — |
| PRIMARY Percentage of Participants With A Serum Potassium <3.2 mEq/L at Week 1 |
— | — |
| PRIMARY Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 2 |
— | — |
| PRIMARY Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 3 |
— | — |
| PRIMARY Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 4 |
— | — |
| PRIMARY Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 5 |
— | — |
| PRIMARY Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 6 |
— | — |
| PRIMARY Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 9 |
— | — |
| PRIMARY Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 13 |
— | — |
| PRIMARY Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 17 |
— | — |
| PRIMARY Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 1 |
— | — |
| PRIMARY Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 2 |
— | — |
| PRIMARY Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 3 |
— | — |
| PRIMARY Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 4 |
— | — |
| PRIMARY Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 5 |
— | — |
| PRIMARY Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 6 |
— | — |
| PRIMARY Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 9 |
— | — |
| PRIMARY Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 13 |
— | — |
| PRIMARY Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 17 |
— | — |
| PRIMARY Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 1 |
— | — |
| PRIMARY Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 2 |
— | — |
| PRIMARY Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 3 |
— | — |
| PRIMARY Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 4 |
— | — |
| PRIMARY Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 5 |
— | — |
| PRIMARY Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 6 |
— | — |
| PRIMARY Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 9 |
— | — |
| PRIMARY Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 13 |
— | — |
| PRIMARY Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 17 |
— | — |
| PRIMARY Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 1. |
— | — |
| PRIMARY Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 2. |
— | — |
| PRIMARY Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 3. |
— | — |
| PRIMARY Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 4. |
— | — |
| PRIMARY Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 5. |
— | — |
| PRIMARY Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 6. |
— | — |
| PRIMARY Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 9. |
— | — |
| PRIMARY Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 13. |
— | — |
| PRIMARY Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 17. |
— | — |
| PRIMARY Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 1 |
— | — |
| PRIMARY Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 2 |
— | — |
| PRIMARY Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 3 |
— | — |
| PRIMARY Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 4 |
— | — |
| PRIMARY Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 5 |
— | — |
| PRIMARY Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 6 |
— | — |
| PRIMARY Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 7 |
— | — |
| PRIMARY Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 8 |
— | — |
| PRIMARY Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 9 |
— | — |
| PRIMARY Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 10 |
— | — |
| PRIMARY Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 11 |
— | — |
| PRIMARY Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 12 |
— | — |
| PRIMARY Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 13 |
— | — |
| PRIMARY Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 14 |
— | — |
| PRIMARY Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 15 |
— | — |
| PRIMARY Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 16 |
— | — |
| PRIMARY Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 17 |
— | — |
| PRIMARY Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 18 |
— | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 1 |
— | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 2 |
— | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 3 |
— | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 4 |
— | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 5 |
— | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 6 |
— | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 8 |
— | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 10 |
— | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 12 |
— | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 14 |
— | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 16 |
— | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 18 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 1 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 2 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 3 |
3 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 4 |
3 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 5 |
3 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 6 |
3 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 8 |
3 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 10 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 12 |
3 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 14 |
3 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 16 |
3 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 18 |
3 | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 1 |
— | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 2 |
— | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 3 |
— | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 4 |
— | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 5 |
— | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 6 |
— | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 8 |
— | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 10 |
— | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 12 |
— | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 14 |
— | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 16 |
— | — |
| PRIMARY Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 18 |
— | — |
| PRIMARY Change in the Inner EAR Instrument Score From Baseline to Week 1 |
— | — |
| PRIMARY Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 2 |
— | — |
| PRIMARY Change in the Inner EAR Instrument Score From Baseline to Week 3 |
— | — |
| PRIMARY Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 4 |
3 | — |
| PRIMARY Change in the Inner EAR Instrument Score From Baseline to Week 5 |
— | — |
| PRIMARY Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 6 |
— | — |
| PRIMARY Change in the Inner EAR Instrument Score From Baseline to Week 8 |
— | — |
| PRIMARY Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 10 |
— | — |
| PRIMARY Change in the Inner EAR Instrument Score From Baseline to Week 12 |
— | — |
| PRIMARY Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 14 |
3 | — |
| PRIMARY Change in the Inner EAR Instrument Score From Baseline to Week 16 |
— | — |
| PRIMARY Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 18 |
6 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 1 |
10 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 2 |
16 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 3 |
11 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 4 |
11 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 5 |
17 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 6 |
6 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 8 |
8 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 10 |
17 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 12 |
12 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 14 |
9 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 16 |
6 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 18 |
9 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 1 |
3 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 2 |
5 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 3 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 4 |
3 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 5 |
6 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 6 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 8 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 10 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 12 |
3 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 14 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 16 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 18 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 1 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 2 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 3 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 4 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 5 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 6 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 8 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 10 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 12 |
3 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 14 |
6 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 16 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 18 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 1 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 2 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 3 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 4 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 5 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 6 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 8 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 10 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 12 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 14 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 16 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 18 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 1 |
5 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 2 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 3 |
3 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 4 |
3 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 5 |
8 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 6 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 8 |
6 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 10 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 12 |
6 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 14 |
3 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 16 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 18 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 1 |
3 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 2 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 3 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 4 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 5 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 6 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 8 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 10 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 12 |
3 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 14 |
6 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 16 |
3 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 18 |
3 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 1 |
3 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 2 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 3 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 4 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 5 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 6 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 8 |
3 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 10 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 12 |
6 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 14 |
6 | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 16 |
— | — |
| PRIMARY Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 18 |
— | — |
| PRIMARY Percentage of Participants Reporting Acceptance of Furosemide at Week 1 |
97 | — |
| PRIMARY Percentage of Participants Reporting Acceptance of Furosemide at Week 2 |
97 | — |
| PRIMARY Percentage of Participants Reporting Acceptance of Furosemide at Week 3 |
94 | — |
| PRIMARY Percentage of Participants Reporting Acceptance of Furosemide at Week 4 |
94 | — |
| PRIMARY Percentage of Participants Reporting Acceptance of Furosemide at Week 5 |
90 | — |
| PRIMARY Percentage of Participants Reporting Acceptance of Furosemide at Week 6 |
97 | — |
| PRIMARY Percentage of Participants Reporting Acceptance of Furosemide at Week 8 |
90 | — |
| PRIMARY Percentage of Participants Reporting Acceptance of Furosemide at Week 10 |
89 | — |
| PRIMARY Percentage of Participants Reporting Acceptance of Furosemide at Week 12 |
96 | — |
| PRIMARY Percentage of Participants Reporting Acceptance of Furosemide at Week 14 |
96 | — |
| PRIMARY Percentage of Participants Reporting Acceptance of Furosemide at Week 16 |
96 | — |
| PRIMARY Percentage of Participants Reporting Acceptance of Furosemide at Week 18 |
92 | — |
| PRIMARY Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 1 |
67 | — |
| PRIMARY Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 2 |
81 | — |
| PRIMARY Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 3 |
52 | — |
| PRIMARY Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 4 |
67 | — |
| PRIMARY Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 5 |
81 | — |
| PRIMARY Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 6 |
81 | — |
| PRIMARY Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 8 |
67 | — |
| PRIMARY Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 10 |
75 | — |
| PRIMARY Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 12 |
83 | — |
| PRIMARY Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 14 |
84 | — |
| PRIMARY Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 16 |
48 | — |
| PRIMARY Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 18 |
75 | — |
| PRIMARY Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 19 |
70 | — |
Summary
Individuals with kidney failure receiving maintenance hemodialysis (HD) have high mortality rates, driven largely by cardiovascular causes. Volume-related factors are critical, modifiable contributors to cardiovascular complications. Reversing volume overload has been shown to improve blood pressure and cardiac remodeling. Use of loop diuretics may represent a pragmatic, low-cost, and low-burden strategy to improve outcomes in people receiving HD. Lack of data on optimal furosemide dosing, safety, and acceptability are barriers to expanded use. This study investigates whether oral furosemide is safe and effective at increasing urine volume in HD patients.
Eligibility Criteria
Inclusion Criteria
- Patient self-report of at least 1 cup urine/24-hours
- Age ≥18 years
- Receipt of thrice weekly in-center HD at a participating clinic (UNC-associated Carolina Dialysis- Carrboro, Siler City, Pittsboro, Sanford, and Lee County)
- ≥60 days receiving in-center HD
- Willingness to take study medication and undergo study testing
- Ability to provide informed consent
Exclusion Criteria
- Known allergy to loop diuretic
- History of poor adherence to HD or medical regimen per nephrologist
- >1 hospitalization in prior 30-days
- Frequent hypotension (systolic BP 30% of HD treatments in prior 30-days)
- Cirrhosis per nephrologist
- Hearing disorder per nephrologist
- Serum potassium <3.5 mEq/L, magnesium <1 mg/dL, or corrected calcium <8 mg/dL in prior 30-days
- Taking a non-loop diuretic (e.g. spironolactone, eplerenone, ethacrynic acid, thiazides)
- Taking an aminoglycoside, cisplatin, methotrexate, cyclosporine, adrenocorticotropic hormone (ACTH), lithium, phenytoin, or oral/intravenous steroid
- Natural licorice consumption
- Prisoners, patients with significant mental illness
- Pregnant patients and nursing mothers
Data sourced from ClinicalTrials.gov (NCT04622709). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.