RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-11-18
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06609343

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.

Ages Eligible for Study:25 Years to 74 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Blood hemoglobin of ≥10.0 g/dL based on most recent routine laboratory profile.
  3. 3. Dialysis adequacy measured with Kt/V of ≥1.2
  4. 4. Ability to understand and the willingness to sign a written informed consent document
  1. 1. Currently on bupropion or hypersensitivity/ intolerance to bupropion by history and monoamine oxidase inhibitors.
  2. 2. Diagnosis or history of eating disorders (bulimia or anorexia nervosa) and seizure.
  3. 3. Pregnant, lactating, childbearing women
  4. 4. History of post-acute COVID-19 syndrome
  5. 5. Diagnosis of depression and/or on antidepressants and bipolar affective disorder
  6. 6. Patient Health Questionnaire (PHQ)-9 score of ≥10
  7. 7. Diagnosis of cognitive impairment including dementia
  8. 8. Current participation in another interventional trial
  9. 9. Scheduled for kidney transplantation in next 6 months
  10. 10. Life expectancy \<6 months as judged by the attending nephrologist/primary care physician.
  11. 11. Current or history of substance abuse or dependency.

Contacts and Locations

Study Contact

Subrata Debnath, MB.BS, PhD
CONTACT
210-567-4700
nath@uthscsa.edu
Samin Sharma, MD
CONTACT
210-567-4700
sharmas1@uthscsa.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-11-18
Study Completion Date2026-11

Study Record Updates

Study Start Date2025-11-18
Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

  • Hemodialysis
  • Kidney dialysis

Additional Relevant MeSH Terms

  • End Stage Renal Disease
  • Fatigue