Pilot Study of Loop Diuretics Among Individuals Receiving Hemodialysis

University of North Carolina (UNC)

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Disease Requiring Chronic Dialysis

Treatments: Drug: Furosemide (loop diuretic) Tablets

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04622709

19-3550

1R03DK124651-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Study drug administration: furosemide

Experimental group

Description:

Study participants will receive furosemide oral tablets to be taken twice daily. During study period 1 (first 6 weeks), the drug dose will be escalated every 2 weeks if safe, tolerated, and acceptable to the participant. During study period 2 (subsequent 12 weeks), participants will take the maximum tolerated dose from study period 1, received every 4 weeks if safe, tolerated, and acceptable to the participant.

Treatment:

Drug: Furosemide (loop diuretic) Tablets