Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
NCT ID: NCT06609343
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
16 participants
INTERVENTIONAL
2026-02-02
2027-01-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hemodialysis Group
Fixed dose bupropion hydrochloride 150 mg extended-release tablets will be administered orally thrice a week during routine dialysis sessions for consecutive 8 weeks.
Bupropion Hydrochloride 150 MG
Bupropion Hydrochloride Extended Release is administered orally three times a week during routine dialysis sessions for 8 consecutive weeks
Interventions
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Bupropion Hydrochloride 150 MG
Bupropion Hydrochloride Extended Release is administered orally three times a week during routine dialysis sessions for 8 consecutive weeks
Eligibility Criteria
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Inclusion Criteria
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
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.
25 Years
74 Years
ALL
No
Sponsors
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The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Subrata Debnath
Assistant Professor
Principal Investigators
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Subrata Debnath, MB.BS, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Locations
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University Hospital Dialysis Medical Center (DMC)
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Subrata Debnath, PhD
Role: primary
Other Identifiers
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STUDY00000814
Identifier Type: -
Identifier Source: org_study_id