About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Blood hemoglobin of ≥10.0 g/dL based on most recent routine laboratory profile.
Dialysis adequacy measured with Kt/V of ≥1.2
Ability to understand and the willingness to sign a written informed consent document
Disqualifiers
Currently on bupropion or hypersensitivity/ intolerance to bupropion by history and monoamine oxidase inhibitors.
Diagnosis or history of eating disorders (bulimia or anorexia nervosa) and seizure.
Pregnant, lactating, childbearing women
History of post-acute COVID-19 syndrome
Trial design
Single group
Treatments tested in this trial
Bupropion Hydrochloride 150 MG
DrugBupropion Hydrochloride Extended Release is administered orally three times a week during routine dialysis sessions for 8 consecutive weeks
Treatment groups
Trial outcomes
Primary outcomes
Change in Brief Fatigue Inventory (BFI) Global Score
This inventory contains 9 items scored from 0-10 with a total possible raw score of 0-90. A lower score indicates that there is less fatigue
Secondary outcomes
Change in plasma concentration of inflammatory marker IL-6
Plasma level of inflammatory marker of interleukin-6 (IL-6)
Change in plasma concentration of inflammatory marker TNF-α
Plasma level of tumor necrosis factor-alpha (TNF-α)
Other outcomes
Change in Cognitive function using Trail Making Test B
The participant will need a pencil to perform each part. The examiner starts timing as soon as the instructions are completed and the participant is signaled to begin. Timing is continued until the participant completes or discontinues the test. The time to completion in seconds is recorded. The maximum score for Part B is 300 seconds with 301" indicating the test was discontinued. A lower score indicates that the participant has better cognitive function and completed the task faster.
Change in Mini-COG score
The score is made up of 2 parts: recall score is 0-3 points, 1 point is assigned for each word correctly recalled without prompt, so the score is higher if more words are recalled. For the clock drawing score, the possible score is 0-2 points, a higher score indicates more accuracy. The total score is between 0-5 with a higher score indicating better cognitive function.
Sponsors and contacts
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