End Stage Renal DiseaseEarly Phase 1OASISNCT05705414
Oral Intradialytic Amino Acid Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis
A Early Phase 1 study testing Valine and EEA in people with End Stage Renal Disease, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Valine and EEA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2024to 30 May 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or Female
- Age 18-64 years
- Receiving 3 x weekly in clinic hemodialysis for at least 6 months
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: 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.
Read the 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
- Being tested
- Valine, EEA
- Keywords
- Fatigue, End-stage kidney disease, Hemodialysis
- Medical subject headings
- Kidney Failure, Chronic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValineDrug
Also called Valine Amino Acid Supplement
A medical food intended for use under medical supervision
EEADrug
Also called Essential Amino Acid Supplement
A medical food intended for use under medical supervision
| Study group | Role | What they receive |
|---|---|---|
| Treatment group Valine then EEA | Experimental | Valine will be administered as two 4 gm packets administered on dialysis treatment day followed by a washout period and then EEA Receives: Drug: Valine; Drug: EEA |
| Treatment group EEA then Valine | Experimental | EAA will be administered as one 12.5 gm packet administered on dialysis treatment day followed by a washout and then Valine Receives: Drug: Valine; Drug: EEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 17 weeks
Secondary outcomes (2)
Handgrip strength test
Change in handgrip strength measured by a dynamometer in lbs
Measured: Baseline to 17 weeks
Trail Making Test (TMT)
Change in minutes to complete Trail Making Test (TMT) A and B
Measured: Baseline to 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start18 Oct 2024
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study design will consist of a crossover schema, with one arm starting on amino acid Valine and the other on EAA for a period of 8 weeks, followed by a washout period of 1 week, and then assignment to the nutritional supplement that they have not already taken for the remaining 8 week period that they are participating in this study.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), IIMS-UT Health San Antonio
- Responsible party
- Sponsor
- Investigators
- Subrata Debnath, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705414
- Sponsor's protocol ID
- HSC20220558H
- Other IDs
- KL2TR002646
- Acronym
- OASIS
- Status last verified
- Aug 2026
- First submitted
- 21 Jan 2023
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Intradialytic Amino Acids Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis (OASIS)
- ClinicalTrials.gov ID
- NCT05705414
- Acronym / sponsor ID
- OASIS / HSC20220558H
- Conditions
- End Stage Renal Disease
- Keywords
- Fatigue, End-stage kidney disease, Hemodialysis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), IIMS-UT Health San Antonio
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study design will consist of a crossover schema, with one arm starting on amino acid Valine and the other on EAA for a period of 8 weeks, followed by a washout period of 1 week, and then assignment to the nutritional supplement that they have not already taken for the remaining 8 week period that they are participating in this study.
| Arm | Type | Receives |
|---|---|---|
| Treatment group Valine then EEA | Experimental | Drug: Valine, Drug: EEAValine will be administered as two 4 gm packets administered on dialysis treatment day followed by a washout period and then EEA |
| Treatment group EEA then Valine | Experimental | Drug: Valine, Drug: EEAEAA will be administered as one 12.5 gm packet administered on dialysis treatment day followed by a washout and then Valine |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or Female
- Age 18-64 years
- Receiving 3 x weekly in clinic hemodialysis for at least 6 months
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ValineAlso: Valine Amino Acid SupplementA medical food intended for use under medical supervision | Drug | Treatment group EEA then Valine, Treatment group Valine then EEA |
| EEAAlso: Essential Amino Acid SupplementA medical food intended for use under medical supervision | Drug | Treatment group EEA then Valine, Treatment group Valine then EEA |
Primary outcome
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.
2 secondary outcomes
Handgrip strength test
Time frame: Baseline to 17 weeks
Trail Making Test (TMT)
Time frame: Baseline to 17 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Subrata Debnath, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Valine and EEA in people with End Stage Renal Disease, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Fatigue Inventory (BFI) score (time frame: Baseline to 17 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.