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

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.

Conditions

End Stage Renal Disease, Fatigue

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
End Stage Renal Disease
Intervention / Treatment

-

Contacts and Locations

San Antonio

University Hospital Dialysis Medical Center (DMC), San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

25 Years to 74 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The University of Texas Health Science Center at San Antonio,

Subrata Debnath, MB.BS., Ph.D., PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center at San Antonio

Study Record Dates

2025-11