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

NCT05705414 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: HSC20220558HKL2TR002646
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Renal Disease

Keywords

Fatigue; End-stage kidney disease; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 17 weeks

Secondary Outcomes (2)

• Handgrip strength test

  Baseline to 17 weeks

• Trail Making Test (TMT)

  Baseline to 17 weeks

Other Outcomes (4)

• Dialysate level of amino acids

  Baseline to 17 weeks

• Plasma level of amino acids

  Baseline to 17 weeks

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

  Baseline to 17 weeks

Study Arms (2)

Treatment group Valine then EEA

EXPERIMENTAL

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

Treatment group EEA then Valine

EXPERIMENTAL

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

Interventions

Valine DRUG

A medical food intended for use under medical supervision

Also known as: Valine Amino Acid Supplement

Treatment group EEA then Valine; Treatment group Valine then EEA

EEA DRUG

A medical food intended for use under medical supervision

Also known as: Essential Amino Acid Supplement

Treatment group EEA then Valine; Treatment group Valine then EEA

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS): collaborator
• The University of Texas Health Science Center at San Antonio: lead
• IIMS-UT Health San Antonio: collaborator

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Fatigue

Interventions

Valine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Subrata Debnath, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Subrata Debnath, PhD

CONTACT

210-567-4700; nath@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The intervention will be administered to the subjects by appropriately trained delegates.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study design will consist of a crossover schema, with one arm starting on amino acid Valine and the other on EAA for a period of 8 weeks, followed by a washout period of 1 week, and then assignment to the nutritional supplement that they have not already taken for the remaining 8 week period that they are participating in this study.

Study Record Dates

• First Submitted: January 21, 2023
• First Posted: January 30, 2023
• Study Start: October 18, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At study completion, once data is published in a peer review journal

Locations

US (1)