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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fatigue; End Stage Renal Disease
• Intervention / Treatment: Drug: Bupropion Hydrochloride 150 MG

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Subrata Debnath, MB.BS, PhD; Phone Number: 210-567-4700; Email: nath@uthscsa.edu
• Study Contact Backup: Name: Swetha Kanduri, MD; Phone Number: 210-567-4700; Email: kanduri@uthscsa.edu

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • University Hospital Dialysis Medical Center (DMC)
      • Contact: Subrata Debnath, PhD; Phone Number: 210-567-4700; Email: nath@uthscsa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion 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

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Bupropion Hydrochloride 150 MG; Bupropion Hydrochloride Extended Release is administered orally three times a week during routine dialysis sessions for 8 consecutive weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Brief Fatigue Inventory (BFI) Global Score	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	Baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in plasma concentration of inflammatory marker IL-6	Plasma level of inflammatory marker of interleukin-6 (IL-6)	Baseline to 8 weeks
Change in plasma concentration of inflammatory marker TNF-α	Plasma level of tumor necrosis factor-alpha (TNF-α)	Baseline to 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cognitive function using Trail Making Test B	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.	Baseline to 8 weeks
Change in Mini-COG score	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.	Baseline to 8 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Investigators: Principal Investigator: Subrata Debnath, MB.BS, Ph.D., The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Hemodialysis; Kidney dialysis
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Fatigue; Kidney Failure, Chronic; Organic Chemicals; Ketones; Propiophenones; Bupropion
• Other Study ID Numbers: STUDY00000814

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Any manuscript, abstract or other publication or presentation of results or information arising in connection with the trial (including any ancillary trial involving trial participants) must use deidentified data.
• IPD Sharing Time Frame: At study completion at the time of publication in a peer review journal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No