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

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: IIMS-UT Health San Antonio; National Center for Advancing Translational Sciences (NCATS)

Criteria

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.