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

NCT06609343 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: STUDY00000814
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End Stage Renal Disease; Fatigue

Keywords

Hemodialysis; Kidney dialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in plasma concentration of inflammatory marker IL-6

  Baseline to 8 weeks

• Change in plasma concentration of inflammatory marker TNF-α

  Baseline to 8 weeks

Other Outcomes (2)

• Change in Cognitive function using Trail Making Test B

  Baseline to 8 weeks

• Change in Mini-COG score

  Baseline to 8 weeks

Study Arms (1)

Hemodialysis Group

EXPERIMENTAL

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

Interventions

Bupropion Hydrochloride 150 MG DRUG

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

Hemodialysis Group

Eligibility Criteria

• Age: 25 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University Hospital Dialysis Medical Center (DMC)

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Fatigue

Interventions

Bupropion

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Study Officials

• Subrata Debnath, MB.BS, Ph.D.

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Subrata Debnath, MB.BS, PhD

CONTACT

210-567-4700; nath@uthscsa.edu

Swetha Kanduri, MD

CONTACT

210-567-4700; kanduri@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A phase 2, open-label, single-arm, single-center, prospective, fixed-dose, 8-week intervention study.

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At study completion at the time of publication in a peer review journal

Locations

US (1)