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

Phase 1

Recruiting

• Conditions: End Stage Renal Disease; Fatigue
• Interventions: Drug: Bupropion Hydrochloride 150 MG

• Registration Number: NCT06609343
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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 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, participants will receive bupropion tablet three times a week during routine dialysis procedure for consecutive 8 weeks. Study participants will complete a battery of questionnaires to self report fatigue, congnition, and quaity of life. The study team will collect biological speciems. All these procedures will be performed at the dialysis clinic during outine dialysis procedure.

Detailed Description

While taking part in this study, participants will be asked to complete study procedures with the researchers or study staff three times during routine dialysis visits. Collection of blood, urine (if available) and stool will be tested to evaluate and compare changes in several parameters including markers of inflammation, amino acids, and for safety labs as needed.

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 Timeline

• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-20
• Study First Posted: 2024-09-24
• Study Start: 2024-10-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-19
• Primary Completion: 2025-06
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hemodialysis Group	Bupropion Hydrochloride 150 MG	Fixed dose bupropion hydrochloride 150 mg extended-release tablets will be administered orally thrice a week during routine dialysis sessions for consecutive 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Brief Fatigue Inventory (BFI) Global Score	Baseline to 8 weeks	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Dialysis Medical Center (DMC); 🇺🇸 San Antonio, Texas, United States