Pilot Study of Loop Diuretics Among Individuals Receiving Hemodialysis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-07

Study Completion Date

2021-06-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Kidney Disease Requiring Chronic Dialysis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study drug administration: furosemide

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.

Group Type EXPERIMENTAL

Furosemide (loop diuretic) Tablets

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No