Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609343
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis BRISK
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRISK
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None