Clinical trial NCT06609343: Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
Official title: Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis (BRISK)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: End Stage Renal Disease
Fatigue
Keywords: Hemodialysis
Kidney dialysis
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 16
Sex: ALL
Minimum age (years): 25
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A phase 2, open-label, single-arm, single-center, prospective, fixed-dose, 8-week intervention study.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Brief Fatigue Inventory (BFI) Global Score
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Change in plasma concentration of inflammatory marker IL-6
timeFrame: Baseline to 8 weeks
measure: Change in plasma concentration of inflammatory marker TNF-α
timeFrame: Baseline to 8 weeks
Other outcomes:
measure: Change in Cognitive function using Trail Making Test B
timeFrame: Baseline to 8 weeks
measure: Change in Mini-COG score
timeFrame: Baseline to 8 weeks
Locations:
city: San Antonio
country: United States
facility: University Hospital Dialysis Medical Center (DMC)
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Subrata Debnath, MB.BS., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: