An Early Phase 1 interventional study of Valine and EEA in End Stage Renal Disease, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by The University of Texas Health Science Center at San Antonio · Early Phase 1, Interventional, and Treatment
The study will test and compare the efficacy of a single essential amino acid valine with a combination of essential amino acids (EAA) supplement on fatigue, frailty, and cognitive function in end-stage kidney disease (ESKD) patients undergoing hemodialysis (HD) treatment.
This single center outpatient study will test and compare the efficacy of a single essential amino acid, valine with a combination of essential amino acids (EAA) supplementation on fatigue, fragility and cognitive function in end-stage kidney disease (ESKD) patients aged 18-64 years undergoing hemodialysis (HD) treatment at least three times a week.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's enrollment of 28 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Valine will be administered as two 4 gm packets administered on dialysis treatment day followed by a washout period and then EEA
Drug: Valine · Drug: EEA
EAA will be administered as one 12.5 gm packet administered on dialysis treatment day followed by a washout and then Valine
Drug: Valine · Drug: EEA
A medical food intended for use under medical supervision
Also known as: Valine Amino Acid Supplement
A medical food intended for use under medical supervision
Also known as: Essential Amino Acid Supplement
Brief Fatigue Inventory (BFI) score
Changes in global fatigue score measured with the 9-item Brief Fatigue Inventory (BFI). The first 3 questions assess fatigue severity, and the remaining 6 questions measure the impact of fatigue on activity, mood, walking, work, relationships, and enjoyment of life. Respondents rate each item on a 0-10 numeric scale, with 0 meaning "no fatigue" and 10 meaning "fatigue as bad as you can imagine." Scores of all 9 items yield global fatigue burden. A lower average global fatigue score indicates milder fatigue and a higher score severe fatigue.
Time frame: Baseline to 17 weeks
Handgrip strength test
Change in handgrip strength measured by a dynamometer in lbs
Time frame: Baseline to 17 weeks
Trail Making Test (TMT)
Change in minutes to complete Trail Making Test (TMT) A and B
Time frame: Baseline to 17 weeks
Dialysate level of amino acids
How is this measured, are there different values for different aa's (if so each one should be reported separately)?
Time frame: Baseline to 17 weeks
Plasma level of amino acids
How is this measured, are there different values for different aa's (if so each one should be reported separately)?
Time frame: Baseline to 17 weeks
Blood valine metabolite 3-hydroxyisobutyrate (3-HIB)
Change in 3-hydroxyisobutyrate (3-HIB) levels
Time frame: Baseline to 17 weeks
Blood valine beta-amino-isobutyric acid (BAIBA)
Change in beta-amino-isobutyric acid (BAIBA)
Time frame: Baseline to 17 weeks
Plan to share: Yes — This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center at San Antonio