NCT05705414

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

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	Valine	A medical food intended for use under medical supervision
DRUG	EEA	A medical food intended for use under medical supervision

Timeline

• Start date: 2024-10-18
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2023-01-30
• Last updated: 2026-01-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study