[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06609343":3,"trial-entities:NCT06609343":89,"trial-summary:NCT06609343":93},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":44,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":58,"locations":61,"central_contacts":77,"overall_officials":83,"references":87,"see_also_links":88},"NCT06609343","STUDY00000814","Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis","Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis (BRISK)","NOT_YET_RECRUITING","2027-01-30","2026-08","2026-08-11","2026-08-24","The University of Texas Health Science Center at San Antonio","OTHER",false,"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.\n\nIn 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.","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.\n\nPrimary Objective: To evaluate the feasibility and efficacy of bupropion for the treatment of fatigue in patients with end-stage kidney disease on maintenance hemodialysis.\n\nSecondary Objective: To evaluate the effect of bupropion in reducing inflammatory markers in hemodialysis patients with fatigue.\n\nExploratory Objective: To examine whether bupropion improves cognitive function.",[19,20],"End Stage Renal Disease","Fatigue",[22,23],"Hemodialysis","Kidney dialysis","INTERVENTIONAL","TREATMENT",[27,28],"PHASE1","PHASE2",{"count":30,"type":31},16,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DRUG","Bupropion Hydrochloride 150 MG","Bupropion Hydrochloride Extended Release is administered orally three times a week during routine dialysis sessions for 8 consecutive weeks",[38],"Hemodialysis Group",[40],{"measure":41,"description":42,"timeFrame":43},"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","Baseline to 8 weeks",[45,48],{"measure":46,"description":47,"timeFrame":43},"Change in plasma concentration of inflammatory marker IL-6","Plasma level of inflammatory marker of interleukin-6 (IL-6)",{"measure":49,"description":50,"timeFrame":43},"Change in plasma concentration of inflammatory marker TNF-α","Plasma level of tumor necrosis factor-alpha (TNF-α)","ALL","25 Years","74 Years",{"inclusion":55,"exclusion":56,"raw_text":57},[],[],"Inclusion Criteria:\n\n1. Male and female ESKD patients between aged 25-74 yrs on maintenance in-center hemodialysis procedure 3 times\u002Fweek for ≥3 months with an arteriovenous fistula or graft.\n2. Blood hemoglobin of ≥10.0 g\u002FdL based on most recent routine laboratory profile.\n3. Dialysis adequacy measured with Kt\u002FV of ≥1.2\n4. Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n1. Currently on bupropion or hypersensitivity\u002F intolerance to bupropion by history and monoamine oxidase inhibitors.\n2. Diagnosis or history of eating disorders (bulimia or anorexia nervosa) and seizure.\n3. Pregnant, lactating, childbearing women\n4. History of post-acute COVID-19 syndrome\n5. Diagnosis of depression and\u002For on antidepressants and bipolar affective disorder\n6. Patient Health Questionnaire (PHQ)-9 score of ≥10\n7. Diagnosis of cognitive impairment including dementia\n8. Current participation in another interventional trial\n9. Scheduled for kidney transplantation in next 6 months\n10. Life expectancy \\\u003C6 months as judged by the attending nephrologist\u002Fprimary care physician.\n11. Current or history of substance abuse or dependency.",[59,60],"ADULT","OLDER_ADULT",[62],{"facility":63,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":74},"University Hospital Dialysis Medical Center (DMC)","San Antonio","Texas","78229","United States",[69],{"name":70,"role":71,"phone":72,"email":73},"Subrata Debnath, PhD","CONTACT","210-567-4700","nath@uthscsa.edu",{"lat":75,"lon":76},29.42412,-98.49363,[78,80],{"name":79,"role":71,"phone":72,"email":73},"Subrata Debnath, MB.BS, PhD",{"name":81,"role":71,"phone":72,"email":82},"Swetha Kanduri, MD","kanduri@uthscsa.edu",[84],{"name":85,"affiliation":13,"role":86},"Subrata Debnath, MB.BS, Ph.D.","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":90,"biomarkers":92},[91],"Chronic Kidney Disease, Stage 5",[],{"nct_id":4,"found":94,"summary":95,"prompt_version":104},true,{"design":96,"status":97,"heading":6,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This is an interventional study, meaning participants will receive a specific treatment. It is a small study, planning to enroll 16 participants.","completed","This study is looking at whether bupropion hydrochloride, a medicine used for depression and to help stop smoking, can reduce fatigue (extreme tiredness) in people with end-stage kidney disease who are on hemodialysis. Fatigue is a very common and difficult symptom for these patients, and there isn't a specific treatment for it right now. You might be able to join if you are between 25 and 74 years old, have end-stage kidney disease, and have been on hemodialysis three times a week for at least three months. To be considered successful, the study hopes to see an improvement in your overall fatigue score after 8 weeks. This study is currently recruiting a small group of 16 participants.","Your fatigue will be measured at the start of the study and again after 8 weeks.",117,"You will take bupropion hydrochloride orally three times a week during your regular dialysis sessions for 8 weeks. You will also complete questionnaires and have blood, and possibly urine and stool, collected at different times.","Not stated in the trial record.",[],"v2"]