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

End Stage Renal Disease Clinical Trial

— OASIS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05705414
• Other study ID #: HSC20220558H
• Secondary ID: KL2TR002646
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: May 2024
• Est. completion date: March 2026

Study information

• Verified date: March 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Subrata Debnath, PhD
• Phone: 210-567-4700
• Email: nath[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: March 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

1. Male or Female

2. Age 18-64 years

3. Receiving 3 x weekly in clinic hemodialysis for at least 6 months

Exclusion Criteria:

1. Hypersensitivity to amino acid(s) and/or any excipient

2. Clinical documentation of COVID-19

3. Concomitant intake of amino acids supplements

4. Current use or abuse of alcohol, marijuana, narcotic, or other substances

5. Heart failure receiving active management

6. Malignant cancer receiving anticancer therapy

7. Diagnosis of major depressive disorder receiving antidepressants

8. Diagnosis of chronic liver disease

9. Cerebrovascular disease with sequelae

10. 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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Drug:
• Valine
A medical food intended for use under medical supervision
• EEA
A medical food intended for use under medical supervision

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	IIMS-UT Health San Antonio, National Center for Advancing Translational Sciences (NCATS)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)?	Baseline to 17 weeks
Other	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)?	Baseline to 17 weeks
Other	Blood valine metabolite 3-hydroxyisobutyrate (3-HIB)	Change in 3-hydroxyisobutyrate (3-HIB) levels	Baseline to 17 weeks
Other	Blood valine beta-amino-isobutyric acid (BAIBA)	Change in beta-amino-isobutyric acid (BAIBA)	Baseline to 17 weeks
Primary	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	Handgrip strength test	Change in handgrip strength measured by a dynamometer in lbs	Baseline to 17 weeks
Secondary	Trail Making Test (TMT)	Change in minutes to complete Trail Making Test (TMT) A and B	Baseline to 17 weeks