Using bupropion to reduce fatigue in kidney disease patients on dialysis
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis (BRISK)
This study is testing if the medication bupropion can help reduce fatigue in people with kidney disease who are on dialysis.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 25 Years to 74 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT06609343 on ClinicalTrials.gov |
What this trial studies
This pilot trial investigates the effectiveness of bupropion, a medication typically used for depression and smoking cessation, in alleviating fatigue among patients with end-stage kidney disease undergoing hemodialysis. Participants will receive bupropion tablets three times a week during their dialysis sessions for eight weeks. Throughout the study, patients will complete questionnaires assessing fatigue, cognition, and quality of life, while biological specimens will be collected for analysis. The primary goal is to evaluate the feasibility and efficacy of bupropion in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25-74 with end-stage kidney disease on maintenance hemodialysis for at least three months.
Not a fit: Patients with a history of depression, cognitive impairment, or those currently taking bupropion or other antidepressants may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from debilitating fatigue due to end-stage kidney disease.
How similar studies have performed: While the use of bupropion for fatigue in this specific population is novel, similar studies have explored its efficacy in other conditions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Antonio, Texas
- University Hospital Dialysis Medical Center (DMC) — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Subrata Debnath, MB.BS., Ph.D. — The University of Texas Health Science Center at San Antonio
- Study coordinator: Subrata Debnath, MB.BS., PhD
- Email: nath@uthscsa.edu
- Phone: 210-567-4700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.