A Phase 1/2 interventional study of Bupropion Hydrochloride 150 MG in End Stage Renal Disease and Fatigue, sponsored by The University of Texas Health Science Center at San Antonio. Not yet recruiting at 1 site in United States. Open to participants aged 25 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by The University of Texas Health Science Center at San Antonio · Phase 1/2, Interventional, and Treatment
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 complete study procedures with the researchers or study staff three times a week during routine dialysis visits. Collections of blood, urine (if available) and stool will be collected at different time points over the 8-week intervention. Blood will be analyzed for markers of inflammation, amino acids, and for safety labs as needed. Blood will also be tested for pharmacokinetics of bupropion.
Primary Objective: To evaluate the feasibility and efficacy of bupropion for the treatment of fatigue in patients with end-stage kidney disease on maintenance hemodialysis.
Secondary Objective: To evaluate the effect of bupropion in reducing inflammatory markers in hemodialysis patients with fatigue.
Exploratory Objective: To examine whether bupropion improves cognitive function.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 16 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 445 studies on the registry; 89 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 35 (54%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fixed dose bupropion hydrochloride 150 mg extended-release tablets will be administered orally thrice a week during routine dialysis sessions for consecutive 8 weeks.
Drug: Bupropion Hydrochloride 150 MG
Bupropion Hydrochloride Extended Release is administered orally three times a week during routine dialysis sessions for 8 consecutive weeks
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
Time frame: Baseline to 8 weeks
Change in plasma concentration of inflammatory marker IL-6
Plasma level of inflammatory marker of interleukin-6 (IL-6)
Time frame: Baseline to 8 weeks
Change in plasma concentration of inflammatory marker TNF-α
Plasma level of tumor necrosis factor-alpha (TNF-α)
Time frame: Baseline to 8 weeks
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.
Time frame: Baseline to 8 weeks
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.
Time frame: Baseline to 8 weeks
Plan to share: Yes — Any manuscript, abstract or other publication or presentation of results or information arising in connection with the trial (including any ancillary trial involving trial participants) must use deidentified data.
Supporting information: Study protocol, Statistical analysis plan
Time frame: At study completion at the time of publication in a peer review journal
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bupropion
The University of Texas Health Science Center at San Antonio →