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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 74
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
University Hospital Dialysis Medical Center (DMC)
RECRUITING
San Antonio
Contact Information
Primary
Subrata Debnath, MB.BS, PhD
nath@uthscsa.edu
210-567-4700
Backup
Samin Sharma, MD
sharmas1@uthscsa.edu
210-567-4700
Time Frame
Start Date: 2025-11-18
Estimated Completion Date: 2026-11
Participants
Target number of participants: 16
Treatments
Experimental: 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.
Sponsors
Leads: The University of Texas Health Science Center at San Antonio

This content was sourced from clinicaltrials.gov