| Trial ID: | L1105 |
| Source ID: | NCT06609343
|
| Associated Drug: |
Bupropion Hydrochloride 150 Mg
|
| Title: |
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
|
| Acronym: |
BRISK
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease|Fatigue
|
| Interventions: |
DRUG: Bupropion Hydrochloride 150 MG
|
| Outcome Measures: |
Primary: 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 | Secondary: Change in plasma concentration of inflammatory marker IL-6, Plasma level of inflammatory marker of interleukin-6 (IL-6), Baseline to 8 weeks|Change in plasma concentration of inflammatory marker TNF-α, Plasma level of tumor necrosis factor-alpha (TNF-α), Baseline to 8 weeks | Other: Change in Cognitive function using Trail Making Test B, The participant will need a pencil to perform each part. The examiner starts timing as soon as the instructions are completed and the participant is signaled to begin. Timing is continued until the participant completes or discontinues the test. The time to completion in seconds is recorded. The maximum score for Part B is 300 seconds with 301" indicating the test was discontinued. A lower score indicates that the participant has better cognitive function and completed the task faster., Baseline to 8 weeks|Change in Mini-COG score, The score is made up of 2 parts: recall score is 0-3 points, 1 point is assigned for each word correctly recalled without prompt, so the score is higher if more words are recalled. For the clock drawing score, the possible score is 0-2 points, a higher score indicates more accuracy. The total score is between 0-5 with a higher score indicating better cognitive function., Baseline to 8 weeks
|
| Sponsor/Collaborators: |
Sponsor: The University of Texas Health Science Center at San Antonio
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
16
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2024-10-18
|
| Completion Date: |
2025-11
|
| Results First Posted: |
|
| Last Update Posted: |
2024-12-19
|
| Locations: |
University Hospital Dialysis Medical Center (DMC), San Antonio, Texas, 78229, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT06609343
|
