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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Drug: Valine; Drug: EEA

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.

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Subrata Debnath, PhD; Phone Number: 210-567-4700; Email: [email protected]

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Valine; A medical food intended for use under medical supervision; Other Names: Valine Amino Acid Supplement; Drug: EEA; A medical food intended for use under medical supervision; Other Names: Essential Amino Acid Supplement
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	Drug: Valine; A medical food intended for use under medical supervision; Other Names: Valine Amino Acid Supplement; Drug: EEA; A medical food intended for use under medical supervision; Other Names: Essential Amino Acid Supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Blood valine metabolite 3-hydroxyisobutyrate (3-HIB)	Change in 3-hydroxyisobutyrate (3-HIB) levels	Baseline to 17 weeks
Blood valine beta-amino-isobutyric acid (BAIBA)	Change in beta-amino-isobutyric acid (BAIBA)	Baseline to 17 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: National Center for Advancing Translational Sciences (NCATS); IIMS-UT Health San Antonio
• Investigators: Principal Investigator: Subrata Debnath, PhD, University of Texas Health Science Center San Antonio

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: January 21, 2023
• First Submitted That Met QC Criteria: January 21, 2023
• First Posted (Estimate): January 30, 2023

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 21, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Fatigue, end-stage kidney disease, hemodialysis
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: HSC20220558H; KL2TR002646 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals.
• IPD Sharing Time Frame: At study completion, once data is published in a peer review journal
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No