End Stage Renal Disease, Fatigue
Conditions
Keywords
Hemodialysis, Kidney dialysis
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.
Interventions
DRUGBupropion Hydrochloride 150 MG
Bupropion Hydrochloride Extended Release is administered orally three times a week during routine dialysis sessions for 8 consecutive weeks
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A phase 2, open-label, single-arm, single-center, prospective, fixed-dose, 8-week intervention study.
Eligibility
Sex/Gender
ALL
Age
25 Years to 74 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Contacts
CONTACTSubrata Debnath, MB.BS, PhD
CONTACTSwetha Kanduri, MD
PRINCIPAL_INVESTIGATORSubrata Debnath, MB.BS, Ph.D.
The University of Texas Health Science Center at San Antonio
Outcome results
None listed