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New treatment option for End Stage Renal Disease
Official title Oral Intradialytic Amino Acid Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis
ClinicalTrials.gov ID: NCT05705414
What this study is testing
What is Valine?
Valine is an investigational medicine, being studied as a potential treatment for end stage renal disease.
Also referred to as Valine Amino Acid Supplement.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- Male or Female
- Age 18-64 years
- Receiving 3 x weekly in clinic hemodialysis for at least 6 months
You likely can't join if
- 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
See the full eligibility criteria
- Male or Female
- Age 18-64 years
- Receiving 3 x weekly in clinic hemodialysis for at least 6 months
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.