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NCT Number: NCT05705414

Oral Intradialytic Amino Acid Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis

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.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Fatigue Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location status: Recruiting

Location contact

Subrata Debnath, PhD

CONTACT

[email protected]

210-567-4700

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female
  • Age 18-64 years
  • Receiving 3 x weekly in clinic hemodialysis for at least 6 months

Exclusion criteria

  • Hypersensitivity to amino acid(s) and/or any excipient
  • Clinical documentation of COVID-19
  • Concomitant intake of amino acids supplements
  • Current use or abuse of alcohol, marijuana, narcotic, or other substances
  • Heart failure receiving active management
  • Malignant cancer receiving anticancer therapy
  • Diagnosis of major depressive disorder receiving antidepressants
  • Diagnosis of chronic liver disease
  • Cerebrovascular disease with sequelae
  • Upper limb amputation, osteoarthritis, or degenerative diseases of fingers, carpel tunnel syndrome in the non-fistula or graft hand preventing completion of hand grip strength test.

Treatment and study plan

Valine

Drug

A medical food intended for use under medical supervision

Other names: Valine Amino Acid Supplement

EEA

Drug

A medical food intended for use under medical supervision

Other names: Essential Amino Acid Supplement

Primary outcomes

  1. Brief Fatigue Inventory (BFI) score

    Time frame: Baseline to 17 weeks

    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.

Secondary outcomes

  1. Handgrip strength test

    Time frame: Baseline to 17 weeks

    Change in handgrip strength measured by a dynamometer in lbs

  2. Trail Making Test (TMT)

    Time frame: Baseline to 17 weeks

    Change in minutes to complete Trail Making Test (TMT) A and B

Other outcomes

  1. Dialysate level of amino acids

    Time frame: Baseline to 17 weeks

    How is this measured, are there different values for different aa's (if so each one should be reported separately)?

  2. Plasma level of amino acids

    Time frame: Baseline to 17 weeks

    How is this measured, are there different values for different aa's (if so each one should be reported separately)?

  3. Blood valine metabolite 3-hydroxyisobutyrate (3-HIB)

    Time frame: Baseline to 17 weeks

    Change in 3-hydroxyisobutyrate (3-HIB) levels

  4. Blood valine beta-amino-isobutyric acid (BAIBA)

    Time frame: Baseline to 17 weeks

    Change in beta-amino-isobutyric acid (BAIBA)

Study contacts

Contact information is provided by the study sponsor or research team.

Subrata Debnath, PhD

CONTACT

[email protected]

210-567-4700

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • IIMS-UT Health San Antonio
  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

Oral Intradialytic Amino Acids Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis (OASIS)

Acronym: OASIS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2023
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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