End Stage Renal DiseasePhase 1/2BRISKNCT06609343
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
A Phase 1/2 study testing Bupropion Hydrochloride 150 MG in people with End Stage Renal Disease and Fatigue, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 74 years
- Conditions the study is for
- End Stage Renal Disease, Fatigue
- What is being tested?
- Bupropion Hydrochloride 150 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2027to May 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University Hospital Dialysis Medical Center (DMC)
San Antonio, Texas, 78229
Subrata Debnath, PhD, 210-567-4700, nath@uthscsa.edu
About this study
Official title: Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis (BRISK)
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.
Read the 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.
- Conditions
- End Stage Renal Disease, Fatigue
- Being tested
- Bupropion Hydrochloride 150 MG
- Keywords
- Hemodialysis, Kidney dialysis
- Medical subject headings
- Kidney Failure, Chronic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupropion Hydrochloride 150 MGDrug
Bupropion Hydrochloride Extended Release is administered orally three times a week during routine dialysis sessions for 8 consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Bupropion Hydrochloride 150 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 8 weeks
Secondary outcomes (2)
Change in plasma concentration of inflammatory marker IL-6
Plasma level of inflammatory marker of interleukin-6 (IL-6)
Measured: Baseline to 8 weeks
Change in plasma concentration of inflammatory marker TNF-α
Plasma level of tumor necrosis factor-alpha (TNF-α)
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study startFeb 2027 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A phase 2, open-label, single-arm, single-center, prospective, fixed-dose, 8-week intervention study.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Subrata Debnath, The University of Texas Health Science Center at San Antonio
- Investigators
- Subrata Debnath, MB.BS, Ph.D., Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609343
- Sponsor's protocol ID
- STUDY00000814
- Acronym
- BRISK
- Status last verified
- Oct 2026
- First submitted
- 20 Sep 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Any manuscript, abstract or other publication or presentation of results or information arising in connection with the trial (including any ancillary trial involving trial participants) must use deidentified data.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis (BRISK)
- ClinicalTrials.gov ID
- NCT06609343
- Acronym / sponsor ID
- BRISK / STUDY00000814
- Conditions
- End Stage Renal Disease, Fatigue
- Keywords
- Hemodialysis, Kidney dialysis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Feb 2027 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A phase 2, open-label, single-arm, single-center, prospective, fixed-dose, 8-week intervention study.
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis Group | Experimental | Drug: Bupropion Hydrochloride 150 MGFixed dose bupropion hydrochloride 150 mg extended-release tablets will be administered orally thrice a week during routine dialysis sessions for consecutive 8 weeks. |
Who may qualify
- Ages
- 25 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupropion Hydrochloride 150 MGBupropion Hydrochloride Extended Release is administered orally three times a week during routine dialysis sessions for 8 consecutive weeks | Drug | Hemodialysis Group |
Primary outcome
Change in Brief Fatigue Inventory (BFI) Global Score
Time frame: 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
2 secondary outcomes
Change in plasma concentration of inflammatory marker IL-6
Time frame: Baseline to 8 weeks
Change in plasma concentration of inflammatory marker TNF-α
Time frame: Baseline to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Yes. Any manuscript, abstract or other publication or presentation of results or information arising in connection with the trial (including any ancillary trial involving trial participants) must use deidentified data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Subrata Debnath, MB.BS, Ph.D. principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bupropion Hydrochloride 150 MG in people with End Stage Renal Disease and Fatigue, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Subrata Debnath, MB.BS, PhD (210-567-4700, nath@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brief Fatigue Inventory (BFI) Global Score (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.