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

The University of Texas System (UT)

Status and phase: Enrolling; Early Phase 1

Conditions: End Stage Renal Disease

Treatments: Drug: Valine; Drug: EEA

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05705414

KL2TR002646 (U.S. NIH Grant/Contract)

HSC20220558H

Details and patient eligibility

About

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 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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

28 participants in 2 patient groups

Treatment group Valine then EEA

Experimental group

Description:

Valine will be administered as two 4 gm packets administered on dialysis treatment day followed by a washout period and then EEA

Treatment:

Drug: EEA

Drug: Valine

Treatment group EEA then Valine

Experimental group

Description:

EAA will be administered as one 12.5 gm packet administered on dialysis treatment day followed by a washout and then Valine

Treatment:

Drug: EEA

Drug: Valine