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NCT Number: NCT06609343

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

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.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Fatigue Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

25 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Hospital Dialysis Medical Center (DMC)

San Antonio, Texas, 78229, United States

Location contact

Subrata Debnath, PhD

CONTACT

[email protected]

210-567-4700

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Diagnosis of depression and/or on antidepressants and bipolar affective disorder
  • Patient Health Questionnaire (PHQ)-9 score of ≥10
  • Diagnosis of cognitive impairment including dementia
  • Current participation in another interventional trial
  • Scheduled for kidney transplantation in next 6 months
  • Life expectancy <6 months as judged by the attending nephrologist/primary care physician.
  • Current or history of substance abuse or dependency.

Treatment and study plan

Bupropion Hydrochloride 150 MG

Drug

Bupropion Hydrochloride Extended Release is administered orally three times a week during routine dialysis sessions for 8 consecutive weeks

Primary outcomes

  1. Change in Brief Fatigue Inventory (BFI) Global Score

    Time frame: Baseline to 8 weeks

    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

  1. Change in plasma concentration of inflammatory marker IL-6

    Time frame: Baseline to 8 weeks

    Plasma level of inflammatory marker of interleukin-6 (IL-6)

  2. Change in plasma concentration of inflammatory marker TNF-α

    Time frame: Baseline to 8 weeks

    Plasma level of tumor necrosis factor-alpha (TNF-α)

Other outcomes

  1. Change in Cognitive function using Trail Making Test B

    Time frame: Baseline to 8 weeks

    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.

  2. Change in Mini-COG score

    Time frame: Baseline to 8 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Subrata Debnath, MB.BS, PhD

CONTACT

[email protected]

210-567-4700

Swetha Kanduri, MD

CONTACT

[email protected]

210-567-4700

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

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

Acronym: BRISK

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 24, 2024
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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