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

Overview

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.

Full Title of Study: “Oral Intradialytic Amino Acids Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis (OASIS)”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: February 2024

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.

Interventions

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

Arms, Groups and Cohorts

• Experimental: Treatment group Valine then EEA
  • Valine will be administered as two 4 gm packets administered on dialysis treatment day followed by a washout period and then EEA
• Experimental: Treatment group EEA then Valine
  • EAA will be administered as one 12.5 gm packet administered on dialysis treatment day followed by a washout and then Valine

Clinical Trial Outcome Measures

Primary Measures

• 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 Measures

• Handgrip strength test
  • Time Frame: Baseline to 17 weeks
  • Change in handgrip strength measured by a dynamometer in lbs
• Trail Making Test (TMT)
  • Time Frame: Baseline to 17 weeks
  • Change in minutes to complete Trail Making Test (TMT) A and B

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • The University of Texas Health Science Center at San Antonio
• Collaborator
  • National Center for Advancing Translational Sciences (NCATS)
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Subrata Debnath, PhD, Principal Investigator, University of Texas Health Science Center San Antonio
• Overall Contact(s)
  • Subrata Debnath, PhD, 210-567-4700, nath@uthscsa.edu