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Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis (BRISK)


Description

Fatigue is the most common symptom reported by end-stage kidney disease patients on maintenance hemodialysis. Unfortunately, there currently is no medical management for this overwhelming feeling of tiredness. As a result, patients continue to suffer with poor quality of life and impaired daily activities. The purpose of this pilot trial is to find out if bupropion (a medicine commonly prescribed for stopping smoking, seasonal mood disorder, and depression) may help lessen fatigue in hemodialysis patients. In this study, hemodialysis participants will receive bupropion tablet orally three times a week during routine dialysis procedure for consecutive 8 weeks. Study participants will complete a battery of questionnaires to self-report fatigue, cognition, and quality of life. The study team will collect biological specimens. All these procedures will be performed at the dialysis clinic during routine dialysis procedure.While taking part in this study, participants will be asked to compl

Trial Eligibility

Inclusion Criteria: 1. Male and female ESKD patients between aged 25-74 yrs on maintenance in-center hemodialysis procedure 3 times/week for ≥3 months with an arteriovenous fistula or graft. 2. Blood hemoglobin of ≥10.0 g/dL based on most recent routine laboratory profile. 3. Dialysis adequacy measured with Kt/V of ≥1.2 4. Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: 1. Currently on bupropion or hypersensitivity/ intolerance to bupropion by history and monoamine oxidase inhibitors. 2. Diagnosis or history of eating disorders (bulimia or anorexia nervosa) and seizure. 3. Pregnant, lactating, childbearing women 4. History of post-acute COVID-19 syndrome 5. Diagnosis of depression and/or on antidepressants and bipolar affective disorder 6. Patient Health Questionnaire (PHQ)-9 score of ≥10 7. Diagnosis of cognitive impairment including dementia 8. Current participation in another interventional trial 9. Scheduled for kidney transplantation in next 6 months 10. Life expectancy \<6 months as judged by the attending nephrologist/primary care physician. 11. Current or history of substance abuse or dependency.

Study Info

Organization

The University of Texas Health Science Center at San Antonio


Primary Outcome

Change in Brief Fatigue Inventory (BFI) Global Score


Outcome Timeframe Baseline to 8 weeks

NCTID NCT06609343

Phases PHASE1,PHASE2

Primary Purpose TREATMENT

Start Date 2024-10-18

Completion Date 2025-06

Enrollment Target 16

Interventions

DRUG Bupropion Hydrochloride 150 MG

Locations Recruiting

University Hospital Dialysis Medical Center (DMC)

United States, Texas, San Antonio


Interested in joining this trial?

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