CompletedPhase 2

Pilot Study of Loop Diuretics Among Individuals Receiving Hemodialysis

United States39 participantsStarted 2020-10-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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)

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)

Percentage of Participants With A Serum Potassium <3.2 mEq/L at Week 1

Timeframe: Study week 1 (1 week after study medication start)

Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 2

Timeframe: Study week 2 (2 weeks after study medication start)

Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 3

Timeframe: Study week 3 (3 weeks after study medication start)

Trial details

NCT IDNCT04622709

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-08

Results submitted2022-04-14

View on ClinicalTrials.gov More Chronic Kidney Disease Requiring Chronic Dialysis trials