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NCT05705414 | Not yet recruiting | End Stage Renal Disease

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

The University of Texas Health Science Center at San Antonio

Brief 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.

Condition or disease

End Stage Renal Disease

Intervention/treatment

Valine

EEA

Phase

Early Phase 1

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
Estimated Enrollment : 28 participants
Masking : None (Open Label)
Masking Description : The intervention will be administered to the subjects by appropriately trained delegates.
Primary Purpose : Treatment
Official Title : Oral Intradialytic Amino Acids Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis (OASIS)
Actual Study Start Date : May 2024
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : March 2026
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

Drug: 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

Drug: Valine

Drug: EEA
Ages Eligible for Study: 18 Years to 64 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Male or Female
  • Age 18-64 years
  • Receiving 3 x weekly in clinic hemodialysis for at least 6 months
Exclusion Criteria
  • Hypersensitivity to amino acid(s) and/or any excipient
  • Clinical documentation of COVID-19
  • Concomitant intake of amino acids supplements
  • Current use or abuse of alcohol, marijuana, narcotic, or other substances
  • Heart failure receiving active management
  • Malignant cancer receiving anticancer therapy
  • Diagnosis of major depressive disorder receiving antidepressants
  • Diagnosis of chronic liver disease
  • Cerebrovascular disease with sequelae
  • 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.
Oral Intradialytic Amino Acid Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis

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

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