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Bupropion for Fatigue in Kidney Failure (BRISK Trial)

Phase 1 & 2

Recruiting

Led By Subrata Debnath, MB.BS., Ph.D.

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female ESKD patients aged 25-74 years on maintenance in-center hemodialysis procedure 3 times/week for ≥3 months with an arteriovenous fistula or graft

Be older than 18 years old

Must not have

History of post-acute COVID-19 syndrome

Scheduled for kidney transplantation in next 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if a medicine called bupropion can help reduce fatigue in patients with end-stage kidney disease who undergo hemodialysis. Participants will take bupropion tablets three times

Who is the study for?

This trial is for end-stage kidney disease patients who experience fatigue while on maintenance hemodialysis. Participants should be currently undergoing routine dialysis and willing to take bupropion tablets during their sessions.

What is being tested?

The study tests if bupropion, a medication used for depression and to quit smoking, can reduce fatigue in hemodialysis patients. It involves taking the drug three times a week for eight weeks during dialysis, along with completing questionnaires about fatigue and quality of life.

What are the potential side effects?

Possible side effects of bupropion include insomnia, dry mouth, headaches, nausea, constipation or diarrhea. Some may experience seizures or mood changes; however these are less common.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 25-74 years old with kidney failure, on hemodialysis 3 times a week for over 3 months, using a fistula or graft.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had long-term effects after recovering from COVID-19.

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I am scheduled for a kidney transplant within the next 6 months.

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I am not currently taking bupropion and have no allergies or bad reactions to it or monoamine oxidase inhibitors.

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I have a history of bulimia, anorexia nervosa, or seizures.

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I am not pregnant, breastfeeding, or able to become pregnant.

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I have been diagnosed with depression or bipolar disorder, or I am taking antidepressants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Brief Fatigue Inventory (BFI) Global Score

Secondary study objectives

Change in plasma concentration of inflammatory marker IL-6

Change in plasma concentration of inflammatory marker TNF-α

Other study objectives

Change in Cognitive function using Trail Making Test B

Change in Mini-COG score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Hemodialysis GroupExperimental Treatment1 Intervention

Fixed dose bupropion hydrochloride 150 mg extended-release tablets will be administered orally thrice a week during routine dialysis sessions for consecutive 8 weeks.

0 / 7Eligibility criteria met