Clinical trial NCT04622709: Pilot Study of Loop Diuretics Among Individuals Receiving Hemodialysis
Official title: Pilot Study of Loop Diuretics Among Individuals Receiving Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Keywords: Hemodialysis
Dialysis
End Stage Renal Disease
Patient-reported Outcomes
Symptoms
Diuretic
Furosemide
Lasix
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-11-10
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-center (multi-clinic), open-label, non-randomized pilot study to test whether oral furosemide is safe and effective at increasing urine volume in HD patients. The study will consist of 2 periods: a 6-week dose escalation period (period 1) and a subsequent 12-week follow-up period (period 2). During period 1, all participants will receive escalating doses of furosemide as tolerated, and the short-term safety, tolerability, and efficacy of furosemide will be examined. During period 2, all participants will continue the maximally tolerated period 1 furosemide dose, and the acceptability of and adherence to furosemide and the longer-term safety and efficacy of furosemide will be examined.
Primary purpose: TREATMENT

Brief 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 \<80 mmHg at \>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

Primary outcomes:
measure: Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 5
timeFrame: Baseline and study week 5 (5 weeks after study medication start
measure: Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 12
timeFrame: Baseline and study week 12 (12 weeks after study medication start)
measure: Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 18
timeFrame: Baseline and study week 18 (18 weeks after study medication start)
measure: Percentage of Participants With A Serum Potassium <3.2 mEq/L at Week 1
timeFrame: Study week 1 (1 week after study medication start)
measure: Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 2
timeFrame: Study week 2 (2 weeks after study medication start)
measure: Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 3
timeFrame: Study week 3 (3 weeks after study medication start)
measure: Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 4
timeFrame: Study week 4 (4 weeks after study medication start)
measure: Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 5
timeFrame: Study week 5 (5 weeks after study medication start)
measure: Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 6
timeFrame: Study week 6 (6 weeks after study medication start)
measure: Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 9
timeFrame: Study week 9 (9 weeks after study medication start)
measure: Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 13
timeFrame: Study week 13 (13 weeks after study medication start)
measure: Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 17
timeFrame: Study week 17 (17 weeks after study medication start)
measure: Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 1
timeFrame: Study week 1 (1 week after study medication start)
measure: Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 2
timeFrame: Study week 2 (2 weeks after study medication start)
measure: Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 3
timeFrame: Study week 3 (3 weeks after study medication start)
measure: Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 4
timeFrame: Study week 4 (4 weeks after study medication start)
measure: Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 5
timeFrame: Study week 5 (5 weeks after study medication start)
measure: Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 6
timeFrame: Study week 6 (6 weeks after study medication start)
measure: Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 9
timeFrame: Study week 9 (9 weeks after study medication start)
measure: Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 13
timeFrame: Study week 13 (13 weeks after study medication start)
measure: Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 17
timeFrame: Study week 17 (17 weeks after study medication start)
measure: Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 1
timeFrame: Study week 1 (1 week after study medication start)
measure: Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 2
timeFrame: Study week 2 (2 weeks after study medication start)
measure: Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 3
timeFrame: Study week 3 (3 weeks after study medication start)
measure: Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 4
timeFrame: Study week 4 (4 weeks after study medication start)
measure: Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 5
timeFrame: Study week 5 (5 weeks after study medication start)
measure: Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 6
timeFrame: Study week 6 (6 weeks after study medication start)
measure: Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 9
timeFrame: Study week 9 (9 weeks after study medication start)
measure: Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 13
timeFrame: Study week 13 (13 weeks after study medication start)
measure: Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 17
timeFrame: Study week 17 (17 weeks after study medication start)
measure: Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 1.
timeFrame: Study week 1 (1 week after study medication start)
measure: Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 2.
timeFrame: Study week 2 (2 weeks after study medication start)
measure: Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 3.
timeFrame: Study week 3 (3 weeks after study medication start)
measure: Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 4.
timeFrame: Study week 4 (4 weeks after study medication start)
measure: Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 5.
timeFrame: Study week 5 (5 weeks after study medication start)
measure: Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 6.
timeFrame: Study week 6 (6 weeks after study medication start)
measure: Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 9.
timeFrame: Study week 9 (9 weeks after study medication start)
measure: Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 13.
timeFrame: Study week 13 (13 weeks after study medication start)
measure: Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 17.
timeFrame: Study week 17 (17 weeks after study medication start)
measure: Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 1
timeFrame: Up to study week 1 (1 week after study medication start)
measure: Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 2
timeFrame: Up to study week 2 (2 weeks after study medication start)
measure: Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 3
timeFrame: Up to study week 3 (3 weeks after study medication start)
measure: Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 4
timeFrame: Up to study week 4 (4 weeks after study medication start)
measure: Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 5
timeFrame: Up to study week 5 (5 weeks after study medication start)
measure: Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 6
timeFrame: Up to study week 6 (6 weeks after study medication start)
measure: Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 7
timeFrame: Up to study week 7 (7 weeks after study medication start)
measure: Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 8
timeFrame: Up to study week 8 (8 weeks after study medication start)
measure: Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 9
timeFrame: Up to study week 9 (9 weeks after study medication start)
measure: Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 10
timeFrame: Up to study week 10 (10 weeks after study medication start)
measure: Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 11
timeFrame: Up to study week 11 (11 weeks after study medication start)
measure: Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 12
timeFrame: Up to study week 12 (12 weeks after study medication start)
measure: Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 13
timeFrame: Up to study week 13 (13 weeks after study medication start)
measure: Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 14
timeFrame: Up to study week 14 (14 weeks after study medication start)
measure: Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 15
timeFrame: Up to study week 15 (15 weeks after study medication start)
measure: Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 16
timeFrame: Up to study week 16 (16 weeks after study medication start)
measure: Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 17
timeFrame: Up to study week 17 (17 weeks after study medication start)
measure: Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 18
timeFrame: Up to study week 18 (18 weeks after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 1
timeFrame: Study week 1 (1 week after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 2
timeFrame: Study week 2 (2 weeks after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 3
timeFrame: Study week 3 (3 weeks after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 4
timeFrame: Study week 4 (4 weeks after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 5
timeFrame: Study week 5 (5 weeks after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 6
timeFrame: Study week 6 (6 weeks after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 8
timeFrame: Study week 8 (8 weeks after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 10
timeFrame: Study week 10 (10 weeks after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 12
timeFrame: Study week 12 (12 weeks after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 14
timeFrame: Study week 14 (14 weeks after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 16
timeFrame: Study week 16 (16 weeks after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 18
timeFrame: Study week 18 (18 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 1
timeFrame: Study week 1 (1 week after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 2
timeFrame: Study week 2 (2 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 3
timeFrame: Study week 3 (3 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 4
timeFrame: Study week 4 (4 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 5
timeFrame: Study week 5 (5 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 6
timeFrame: Study week 6 (6 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 8
timeFrame: Study week 8 (8 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 10
timeFrame: Study week 10 (10 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 12
timeFrame: Study week 12 (12 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 14
timeFrame: Study week 14 (14 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 16
timeFrame: Study week 16 (16 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 18
timeFrame: Study week 18 (18 weeks after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 1
timeFrame: Study week 1 (1 week after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 2
timeFrame: Study week 2 (2 weeks after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 3
timeFrame: Study week 3 (3 weeks after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 4
timeFrame: Study week 4 (4 weeks after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 5
timeFrame: Study week 5 (5 weeks after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 6
timeFrame: Study week 6 (6 weeks after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 8
timeFrame: Study week 8 (8 weeks after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 10
timeFrame: Study week 10 (10 weeks after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 12
timeFrame: Study week 12 (12 weeks after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 14
timeFrame: Study week 14 (14 weeks after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 16
timeFrame: Study week 16 (16 weeks after study medication start)
measure: Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 18
timeFrame: Study week 18 (18 weeks after study medication start)
measure: Change in the Inner EAR Instrument Score From Baseline to Week 1
timeFrame: Baseline and study week 1 (1 week after study medication start)
measure: Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 2
timeFrame: Baseline and study week 2 (2 weeks after study medication start)
measure: Change in the Inner EAR Instrument Score From Baseline to Week 3
timeFrame: Baseline and study week 3 (3 weeks after study medication start)
measure: Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 4
timeFrame: Baseline and study week 4 (4 weeks after study medication start)
measure: Change in the Inner EAR Instrument Score From Baseline to Week 5
timeFrame: Baseline and study week 5 (5 weeks after study medication start)
measure: Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 6
timeFrame: Baseline and study week 6 (6 weeks after study medication start)
measure: Change in the Inner EAR Instrument Score From Baseline to Week 8
timeFrame: Baseline and study week 8 (8 weeks after study medication start)
measure: Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 10
timeFrame: Baseline and study week 10 (10 weeks after study medication start)
measure: Change in the Inner EAR Instrument Score From Baseline to Week 12
timeFrame: Baseline and study week 12 (12 weeks after study medication start)
measure: Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 14
timeFrame: Baseline and study week 14 (14 weeks after study medication start)
measure: Change in the Inner EAR Instrument Score From Baseline to Week 16
timeFrame: Baseline and study week 16 (16 weeks after study medication start)
measure: Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 18
timeFrame: Baseline and study week 18 (18 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 1
timeFrame: Study week 1 (1 week after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 2
timeFrame: Study week 2 (2 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 3
timeFrame: Study week 3 (3 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 4
timeFrame: Study week 4 (4 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 5
timeFrame: Study week 5 (5 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 6
timeFrame: Study week 6 (6 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 8
timeFrame: Study week 8 (8 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 10
timeFrame: Study week 10 (10 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 12
timeFrame: Study week 12 (12 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 14
timeFrame: Study week 14 (14 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 16
timeFrame: Study week 16 (16 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 18
timeFrame: Study week 18 (18 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 1
timeFrame: Study week 1 (1 week after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 2
timeFrame: Study week 2 (2 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 3
timeFrame: Study week 3 (3 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 4
timeFrame: Study week 4 (4 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 5
timeFrame: Study week 5 (5 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 6
timeFrame: Study week 6 (6 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 8
timeFrame: Study week 8 (8 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 10
timeFrame: Study week 10 (10 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 12
timeFrame: Study week 12 (12 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 14
timeFrame: Study week 14 (14 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 16
timeFrame: Study week 16 (16 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 18
timeFrame: Study week 18 (18 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 1
timeFrame: Study week 1 (1 week after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 2
timeFrame: Study week 2 (2 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 3
timeFrame: Study week 3 (3 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 4
timeFrame: Study week 4 (4 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 5
timeFrame: Study week 5 (5 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 6
timeFrame: Study week 6 (6 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 8
timeFrame: Study week 8 (8 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 10
timeFrame: Study week 10 (10 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 12
timeFrame: Study week 12 (12 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 14
timeFrame: Study week 14 (14 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 16
timeFrame: Study week 16 (16 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 18
timeFrame: Study week 18 (18 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 1
timeFrame: Study week 1 (1 week after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 2
timeFrame: Study week 2 (2 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 3
timeFrame: Study week 3 (3 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 4
timeFrame: Study week 4 (4 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 5
timeFrame: Study week 5 (5 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 6
timeFrame: Study week 6 (6 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 8
timeFrame: Study week 8 (8 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 10
timeFrame: Study week 10 (10 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 12
timeFrame: Study week 12 (12 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 14
timeFrame: Study week 14 (14 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 16
timeFrame: Study week 16 (16 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 18
timeFrame: Study week 18 (18 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 1
timeFrame: Study week 1 (1 week after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 2
timeFrame: Study week 2 (2 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 3
timeFrame: Study week 3 (3 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 4
timeFrame: Study week 4 (4 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 5
timeFrame: Study week 5 (5 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 6
timeFrame: Study week 6 (6 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 8
timeFrame: Study week 8 (8 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 10
timeFrame: Study week 10 (10 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 12
timeFrame: Study week 12 (12 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 14
timeFrame: Study week 14 (14 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 16
timeFrame: Study week 16 (16 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 18
timeFrame: Study week 18 (18 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 1
timeFrame: Study week 1 (1 week after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 2
timeFrame: Study week 2 (2 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 3
timeFrame: Study week 3 (3 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 4
timeFrame: Study week 4 (4 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 5
timeFrame: Study week 5 (5 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 6
timeFrame: Study week 6 (6 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 8
timeFrame: Study week 8 (8 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 10
timeFrame: Study week 10 (10 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 12
timeFrame: Study week 12 (12 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 14
timeFrame: Study week 14 (14 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 16
timeFrame: Study week 16 (16 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 18
timeFrame: Study week 18 (18 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 1
timeFrame: Study week 1 (1 week after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 2
timeFrame: Study week 2 (2 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 3
timeFrame: Study week 3 (3 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 4
timeFrame: Study week 4 (4 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 5
timeFrame: Study week 5 (5 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 6
timeFrame: Study week 6 (6 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 8
timeFrame: Study week 8 (8 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 10
timeFrame: Study week 10 (10 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 12
timeFrame: Study week 12 (12 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 14
timeFrame: Study week 14 (14 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 16
timeFrame: Study week 16 (16 weeks after study medication start)
measure: Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 18
timeFrame: Study week 18 (18 weeks after study medication start)
measure: Percentage of Participants Reporting Acceptance of Furosemide at Week 1
timeFrame: Study week 1 (1 week after study medication start)
measure: Percentage of Participants Reporting Acceptance of Furosemide at Week 2
timeFrame: Study week 2 (2 weeks after study medication start)
measure: Percentage of Participants Reporting Acceptance of Furosemide at Week 3
timeFrame: Study week 3 (3 weeks after study medication start)
measure: Percentage of Participants Reporting Acceptance of Furosemide at Week 4
timeFrame: Study week 4 (4 weeks after study medication start)
measure: Percentage of Participants Reporting Acceptance of Furosemide at Week 5
timeFrame: Study week 5 (5 weeks after study medication start)
measure: Percentage of Participants Reporting Acceptance of Furosemide at Week 6
timeFrame: Study week 6 (6 weeks after study medication start)
measure: Percentage of Participants Reporting Acceptance of Furosemide at Week 8
timeFrame: Study week 8 (8 weeks after study medication start)
measure: Percentage of Participants Reporting Acceptance of Furosemide at Week 10
timeFrame: Study week 10 (10 weeks after study medication start)
measure: Percentage of Participants Reporting Acceptance of Furosemide at Week 12
timeFrame: Study week 12 (12 weeks after study medication start)
measure: Percentage of Participants Reporting Acceptance of Furosemide at Week 14
timeFrame: Study week 14 (14 weeks after study medication start)
measure: Percentage of Participants Reporting Acceptance of Furosemide at Week 16
timeFrame: Study week 16 (16 weeks after study medication start)
measure: Percentage of Participants Reporting Acceptance of Furosemide at Week 18
timeFrame: Study week 18 (18 weeks after study medication start)
measure: Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 1
timeFrame: Study week 1 (1 week after study medication start)
measure: Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 2
timeFrame: Study week 2 (2 weeks after study medication start)
measure: Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 3
timeFrame: Study week 3 (3 weeks after study medication start)
measure: Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 4
timeFrame: Study week 4 (4 weeks after study medication start)
measure: Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 5
timeFrame: Study week 5 (5 weeks after study medication start)
measure: Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 6
timeFrame: Study week 6 (6 weeks after study medication start)
measure: Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 8
timeFrame: Study week 8 (8 weeks after study medication start)
measure: Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 10
timeFrame: Study week 10 (10 weeks after study medication start)
measure: Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 12
timeFrame: Study week 12 (12 weeks after study medication start)
measure: Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 14
timeFrame: Study week 14 (14 weeks after study medication start)
measure: Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 16
timeFrame: Study week 16 (16 weeks after study medication start)
measure: Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 18
timeFrame: Study week 18 (18 weeks after study medication start)
measure: Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 19
timeFrame: Study week 19 (19 weeks after study medication start)
Secondary outcomes:
Other outcomes:
Locations:
city: Carrboro
country: United States
facility: Carolina Dialysis - Carrboro
state: North Carolina
city: Pittsboro
country: United States
facility: Carolina Dialysis - Pittsboro
state: North Carolina
city: Sanford
country: United States
facility: Carolina Dialysis - Sanford
state: North Carolina
city: Sanford
country: United States
facility: Carolina Dialysis - Lee County
state: North Carolina
city: Siler City
country: United States
facility: Carolina Dialysis - Siler City
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jennifer Flythe, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: