Chronic Kidney DiseaseEarly Phase 1BOOST_CKDNCT07437053
Sarcopenia in Chronic Kidney Disease (CKD) Patients
A Early Phase 1 study testing Valine and EEA in people with Chronic Kidney Disease and Sarcopenia, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Sarcopenia, or loss of muscle and strength is common in patients with poor kidney function. Although a high protein diet is generally recommended for sarcopenia, patients with poor kidney function are advised to follow a low-protein diet. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Chronic Kidney Disease, Sarcopenia
- What is being tested?
- Valine and EEA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2027to Dec 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability of participant to understand and the willingness to sign a written informed consent document.
- Males and females of age 45-75 yrs
- Hand grip strength of <26 kg for male and <16 kg for female
- Documented diagnosis of estimated glomerular filtration rate (eGFR) of ≤15 mL/min/1.73 m2, based on CKD-EPI serum-creatinine based formula in the past ≥3 months in absence of acute kidney injury.
- Not on dialysis and is not expected to initiate dialysis or any kidney replacement therapy in next 4 months
- Receiving standard of care including dietary recommendation for diabetes, hypertension, CKD, and other comorbidities
Show all 12Show fewer
- Patients who are on an SGLT2-i or GLP-1 agonist should be on a stable dose for at least 3 months prior randomization, with no dose adjustments expected in the next 4 months
- Serum HCO3 concentration 20-29 mmol/L based on two consecutive recent routine labs
- HbA1c 7-9% based on most recent routine lab
- Serum albumin ≥3.8 g/dL based on most recent routine lab
- Blood hemoglobin ≥10 g/dL based on most recent routine lab
- Willingness to adhere to lifestyle management, including diet and exercise as recommended by care providers, and to the study intervention, procedures, and regimen.
Who cannot join
- Any known history of hypersensitivity/intolerance to valine or specific amino acids
- Any condition that may indicate the individual is not "metabolically stable" which may include active infection, currently on systemic antibiotic, hospitalization within 2 weeks on consenting, active malignancy, on immunosuppressive agents, and unexplained significant weight loss during the past 3 months
- With a cardiac pacemaker and/or an implantable cardioverter-defibrillator
- Significant arthritis prohibiting strength test and walk gait speed test
- Significant comorbidities including heart failure (NY Class III or IV), neurological disorders, HIV AIDS, etiology of CKD other than diabetes and hypertension, or any condition that could compromise the subject's ability to study procedures as judged by study clinician
- Currently taking any protein supplements
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- Pregnant, lactating, childbearing women
- History of Maple syrup urine disease (MSUD)
- Scheduled for kidney transplantation or dialysis in next 4 months
- Current participation in another interventional trial
- Documented noncompliance with regard to clinic visits, medications, and lifestyle management.
- Documentation of current or history of substance abuse.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Subrata Debnath, PhD, 210-567-4700, nath@uthscsa.edu
About this study
Official title: Branched-chain Amino Acids to Improve Sarcopenia in Patients With Advanced Chronic Kidney Disease (BOOST-CKD)
Sarcopenia, or loss of muscle and strength is common in patients with poor kidney function. Although a high protein diet is generally recommended for sarcopenia, patients with poor kidney function are advised to follow a low-protein diet. In this study, we will evaluate the practicality and potential benefits of two different amino acids (molecules that form proteins) in improving sarcopenia in patients with advanced kidney disease.
The study aims to improve muscle mass and strength. All study procedures are free of cost and do not require significant time commitment. You will have time to ask questions and discuss the study with your family, primary care physician, and your kidney doctor to make the decision if this is right study for you to participate in.
Read the detailed description
The overall objective of this study is to evaluate the feasibility, tolerability, metabolic effects, and potential therapeutic potential of isolated valine or EAA in patients with CKD stage 5.
- Primary Objective: To evaluate the feasibility, tolerability, and potential therapeutic benefits of isolated valine or EAA for the management of sarcopenia in patients with stage 5 CKD not on dialysis.
- Secondary Objectives: To assess the effects of valine and EAA on measures of kidney function and anorexia in patients with stage 5 CKD not on dialysis.
- Conditions
- Chronic Kidney Disease, Sarcopenia
- Being tested
- Valine, EEA
- Keywords
- Valine, Essential amino acid, Metabolic effects
- Medical subject headings
- Renal Insufficiency, Chronic, Sarcopenia
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 | Experimental | Daily oral consumption of 2 g valine, divided into two meals (1 g per meal, one packet), each equivalent to approximately 0.8 g of protein. Receives: Drug: Valine |
| Treatment group EEA | Experimental | Daily oral consumption of 20 g essential amino acids (EAA), divided into two meals (10 g per meal, one packet), each equivalent to 5 g of protein and 3.14 g of branched chain amino acids (BCAA). Receives: Drug: EEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle strength (handgrip strength test)
Change from baseline handgrip strength test value (kg) measured using a hand dynamometer to the end of each 6-Week intervention
Measured: Baseline to 14 weeks
Muscle mass
Change from baseline muscle mass using a bioelectrical impedance analysis to the end of each 6-Week intervention
Measured: Baseline to 14 weeks
Physical performance (4-meter Walk Gait Speed Test or 4MWT)
Change from baseline 4MWT (measured in second) to the end of each 6-Week intervention
Measured: Baseline to 14 weeks
Incidence of patient-reported symptoms
Change from baseline (number of symptoms) to the end of each 6-Week intervention
Measured: Baseline to 14 weeks
Secondary outcomes (1)
Functional Assessment of Anorexia/Cachexia Therapy (FAACT) Anorexia subscale
Change from baseline scores (ranging from 0-48, with 0 being the worst possible score) to the end of each 6-Week intervention
Measured: Baseline to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study startJul 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney 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 single center, prospective, randomized crossover open label pilot study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Subrata Debnath, The University of Texas Health Science Center at San Antonio
- Investigators
- Subrata Debnath, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437053
- Sponsor's protocol ID
- STUDY00002368
- Acronym
- BOOST_CKD
- Status last verified
- Oct 2026
- First submitted
- 20 Feb 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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.
Publications
Duarte MP, Almeida LS, Neri SGR, Oliveira JS, Wilkinson TJ, Ribeiro HS, Lima RM. Prevalence of sarcopenia in patients with chronic kidney disease: a global systematic review and meta-analysis. J Cachexia Sarcopenia Muscle. 2024 Apr;15(2):501-512. doi: 10.1002/jcsm.13425. Epub 2024 Jan 24.
PubMed 38263952Alvestrand A, Furst P, Bergstrom J. Plasma and muscle free amino acids in uremia: influence of nutrition with amino acids. Clin Nephrol. 1982 Dec;18(6):297-305.
PubMed 7151348Ikizler TA, Burrowes JD, Byham-Gray LD, Campbell KL, Carrero JJ, Chan W, Fouque D, Friedman AN, Ghaddar S, Goldstein-Fuchs DJ, Kaysen GA, Kopple JD, Teta D, Yee-Moon Wang A, Cuppari L. KDOQI Clinical Practice Guideline for Nutrition in CKD: 2020 Update. Am J Kidney Dis. 2020 Sep;76(3 Suppl 1):S1-S107. doi: 10.1053/j.ajkd.2020.05.006.
PubMed 32829751Jiang S, Fang J, Li W. Protein restriction for diabetic kidney disease. Cochrane Database Syst Rev. 2023 Jan 3;1(1):CD014906. doi: 10.1002/14651858.CD014906.pub2.
PubMed 36594428Laidlaw SA, Berg RL, Kopple JD, Naito H, Walker WG, Walser M. Patterns of fasting plasma amino acid levels in chronic renal insufficiency: results from the feasibility phase of the Modification of Diet in Renal Disease Study. Am J Kidney Dis. 1994 Apr;23(4):504-13. doi: 10.1016/s0272-6386(12)80371-4.
PubMed 8154485Wu Y, Chen J, Tao Y, Xiao M, Xiong J, Chen A, Ma X, Li L, Jia H, Zhang Q, Xue Y, Jia Y, Zheng Z. Association between dietary protein intake and mortality among patients with diabetic kidney disease. Diabetes Metab Syndr. 2024 Jul;18(7):103091. doi: 10.1016/j.dsx.2024.103091. Epub 2024 Jul 27.
PubMed 39084052Tizianello A, Deferrari G, Garibotto G, Robaudo C, Lutman M, Passerone G, Bruzzone M. Branched-chain amino acid metabolism in chronic renal failure. Kidney Int Suppl. 1983 Dec;16:S17-22.
PubMed 6588248Block KP, Harper AE. Valine metabolism in vivo: effects of high dietary levels of leucine and isoleucine. Metabolism. 1984 Jun;33(6):559-66. doi: 10.1016/0026-0495(84)90012-x.
PubMed 6727655Burns J, Cresswell E, Ell S, Fynn M, Jackson MA, Lee HA, Richards P, Rowlands A, Talbot S. Comparison of the effects of keto acid analogues and essential amino acids on nitrogen homeostasis in uremic patients on moderately protein-restricted diets. Am J Clin Nutr. 1978 Oct;31(10):1767-75. doi: 10.1093/ajcn/31.10.1767.
PubMed 707331Masud T, Young VR, Chapman T, Maroni BJ. Adaptive responses to very low protein diets: the first comparison of ketoacids to essential amino acids. Kidney Int. 1994 Apr;45(4):1182-92. doi: 10.1038/ki.1994.157.
PubMed 8007590Sunsandee N, Thimachai P, Satirapoj B, Supasyndh O. Anti-sarcopenic effect of leucine-enriched branched-chain amino acid supplementation among elderly chronic kidney disease patients: a double-blinded randomized controlled trial. Int Urol Nephrol. 2025 Nov;57(11):3811-3819. doi: 10.1007/s11255-025-04560-9. Epub 2025 May 17.
PubMed 40381110Studenski SA, Peters KW, Alley DE, Cawthon PM, McLean RR, Harris TB, Ferrucci L, Guralnik JM, Fragala MS, Kenny AM, Kiel DP, Kritchevsky SB, Shardell MD, Dam TT, Vassileva MT. The FNIH sarcopenia project: rationale, study description, conference recommendations, and final estimates. J Gerontol A Biol Sci Med Sci. 2014 May;69(5):547-58. doi: 10.1093/gerona/glu010.
PubMed 24737557Bhasin S, Travison TG, Manini TM, Patel S, Pencina KM, Fielding RA, Magaziner JM, Newman AB, Kiel DP, Cooper C, Guralnik JM, Cauley JA, Arai H, Clark BC, Landi F, Schaap LA, Pereira SL, Rooks D, Woo J, Woodhouse LJ, Binder E, Brown T, Shardell M, Xue QL, D'Agostino RB Sr, Orwig D, Gorsicki G, Correa-De-Araujo R, Cawthon PM. Sarcopenia Definition: The Position Statements of the Sarcopenia Definition and Outcomes Consortium. J Am Geriatr Soc. 2020 Jul;68(7):1410-1418. doi: 10.1111/jgs.16372. Epub 2020 Mar 9.
PubMed 32150289
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Branched-chain Amino Acids to Improve Sarcopenia in Patients With Advanced Chronic Kidney Disease (BOOST-CKD)
- ClinicalTrials.gov ID
- NCT07437053
- Acronym / sponsor ID
- BOOST_CKD / STUDY00002368
- Conditions
- Chronic Kidney Disease, Sarcopenia
- Keywords
- Valine, Essential amino acid, Metabolic effects
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Jul 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 27 Feb 2026 (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.
Sarcopenia, or loss of muscle and strength is common in patients with poor kidney function. Although a high protein diet is generally recommended for sarcopenia, patients with poor kidney function are advised to follow a low-protein diet. In this study, we will evaluate the practicality and potential benefits of two different amino acids (molecules that form proteins) in improving sarcopenia in patients with advanced kidney disease.
The study aims to improve muscle mass and strength. All study procedures are free of cost and do not require significant time commitment. You will have time to ask questions and discuss the study with your family, primary care physician, and your kidney doctor to make the decision if this is right study for you to participate in.
Detailed description
The overall objective of this study is to evaluate the feasibility, tolerability, metabolic effects, and potential therapeutic potential of isolated valine or EAA in patients with CKD stage 5.
- Primary Objective: To evaluate the feasibility, tolerability, and potential therapeutic benefits of isolated valine or EAA for the management of sarcopenia in patients with stage 5 CKD not on dialysis.
- Secondary Objectives: To assess the effects of valine and EAA on measures of kidney function and anorexia in patients with stage 5 CKD not on dialysis.
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 single center, prospective, randomized crossover open label pilot study
| Arm | Type | Receives |
|---|---|---|
| Treatment group Valine | Experimental | Drug: ValineDaily oral consumption of 2 g valine, divided into two meals (1 g per meal, one packet), each equivalent to approximately 0.8 g of protein. |
| Treatment group EEA | Experimental | Drug: EEADaily oral consumption of 20 g essential amino acids (EAA), divided into two meals (10 g per meal, one packet), each equivalent to 5 g of protein and 3.14 g of branched chain amino acids (BCAA). |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Ability of participant to understand and the willingness to sign a written informed consent document.
- Males and females of age 45-75 yrs
- Hand grip strength of <26 kg for male and <16 kg for female
- Documented diagnosis of estimated glomerular filtration rate (eGFR) of ≤15 mL/min/1.73 m2, based on CKD-EPI serum-creatinine based formula in the past ≥3 months in absence of acute kidney injury.
- Not on dialysis and is not expected to initiate dialysis or any kidney replacement therapy in next 4 months
Key exclusion criteria (12 listed)
- Any known history of hypersensitivity/intolerance to valine or specific amino acids
- Any condition that may indicate the individual is not "metabolically stable" which may include active infection, currently on systemic antibiotic, hospitalization within 2 weeks on consenting, active malignancy, on immunosuppressive agents, and unexplained significant weight loss during the past 3 months
- With a cardiac pacemaker and/or an implantable cardioverter-defibrillator
- Significant arthritis prohibiting strength test and walk gait speed test
- Significant comorbidities including heart failure (NY Class III or IV), neurological disorders, HIV AIDS, etiology of CKD other than diabetes and hypertension, or any condition that could compromise the subject's ability to study procedures as judged by study clinician
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 Valine |
| EEAAlso: Essential Amino Acid SupplementA medical food intended for use under medical supervision | Drug | Treatment group EEA |
Primary outcome
Skeletal muscle strength (handgrip strength test)
Time frame: Baseline to 14 weeks
Change from baseline handgrip strength test value (kg) measured using a hand dynamometer to the end of each 6-Week intervention
Muscle mass
Time frame: Baseline to 14 weeks
Change from baseline muscle mass using a bioelectrical impedance analysis to the end of each 6-Week intervention
Physical performance (4-meter Walk Gait Speed Test or 4MWT)
Time frame: Baseline to 14 weeks
Change from baseline 4MWT (measured in second) to the end of each 6-Week intervention
Incidence of patient-reported symptoms
Time frame: Baseline to 14 weeks
Change from baseline (number of symptoms) to the end of each 6-Week intervention
1 secondary outcome
Functional Assessment of Anorexia/Cachexia Therapy (FAACT) Anorexia subscale
Time frame: Baseline to 14 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Results publication: PubMed 38263952Duarte MP, Almeida LS, Neri SGR, Oliveira JS, Wilkinson TJ, Ribeiro HS, Lima RM. Prevalence of sarcopenia in patients with chronic kidney disease: a global systematic review and meta-analysis. J Cachexia Sarcopenia Muscle. 2024 Apr;15(2):501-512. doi: 10.1002/jcsm.13425. Epub 2024 Jan 24.
- Results publication: PubMed 7151348Alvestrand A, Furst P, Bergstrom J. Plasma and muscle free amino acids in uremia: influence of nutrition with amino acids. Clin Nephrol. 1982 Dec;18(6):297-305.
- Results publication: PubMed 32829751Ikizler TA, Burrowes JD, Byham-Gray LD, Campbell KL, Carrero JJ, Chan W, Fouque D, Friedman AN, Ghaddar S, Goldstein-Fuchs DJ, Kaysen GA, Kopple JD, Teta D, Yee-Moon Wang A, Cuppari L. KDOQI Clinical Practice Guideline for Nutrition in CKD: 2020 Update. Am J Kidney Dis. 2020 Sep;76(3 Suppl 1):S1-S107. doi: 10.1053/j.ajkd.2020.05.006.
- Results publication: PubMed 36594428Jiang S, Fang J, Li W. Protein restriction for diabetic kidney disease. Cochrane Database Syst Rev. 2023 Jan 3;1(1):CD014906. doi: 10.1002/14651858.CD014906.pub2.
- Results publication: PubMed 8154485Laidlaw SA, Berg RL, Kopple JD, Naito H, Walker WG, Walser M. Patterns of fasting plasma amino acid levels in chronic renal insufficiency: results from the feasibility phase of the Modification of Diet in Renal Disease Study. Am J Kidney Dis. 1994 Apr;23(4):504-13. doi: 10.1016/s0272-6386(12)80371-4.
- Results publication: PubMed 39084052Wu Y, Chen J, Tao Y, Xiao M, Xiong J, Chen A, Ma X, Li L, Jia H, Zhang Q, Xue Y, Jia Y, Zheng Z. Association between dietary protein intake and mortality among patients with diabetic kidney disease. Diabetes Metab Syndr. 2024 Jul;18(7):103091. doi: 10.1016/j.dsx.2024.103091. Epub 2024 Jul 27.
- Results publication: PubMed 6588248Tizianello A, Deferrari G, Garibotto G, Robaudo C, Lutman M, Passerone G, Bruzzone M. Branched-chain amino acid metabolism in chronic renal failure. Kidney Int Suppl. 1983 Dec;16:S17-22.
- Results publication: PubMed 6727655Block KP, Harper AE. Valine metabolism in vivo: effects of high dietary levels of leucine and isoleucine. Metabolism. 1984 Jun;33(6):559-66. doi: 10.1016/0026-0495(84)90012-x.
- Results publication: PubMed 707331Burns J, Cresswell E, Ell S, Fynn M, Jackson MA, Lee HA, Richards P, Rowlands A, Talbot S. Comparison of the effects of keto acid analogues and essential amino acids on nitrogen homeostasis in uremic patients on moderately protein-restricted diets. Am J Clin Nutr. 1978 Oct;31(10):1767-75. doi: 10.1093/ajcn/31.10.1767.
- Results publication: PubMed 8007590Masud T, Young VR, Chapman T, Maroni BJ. Adaptive responses to very low protein diets: the first comparison of ketoacids to essential amino acids. Kidney Int. 1994 Apr;45(4):1182-92. doi: 10.1038/ki.1994.157.
- Results publication: PubMed 40381110Sunsandee N, Thimachai P, Satirapoj B, Supasyndh O. Anti-sarcopenic effect of leucine-enriched branched-chain amino acid supplementation among elderly chronic kidney disease patients: a double-blinded randomized controlled trial. Int Urol Nephrol. 2025 Nov;57(11):3811-3819. doi: 10.1007/s11255-025-04560-9. Epub 2025 May 17.
- Results publication: PubMed 24737557Studenski SA, Peters KW, Alley DE, Cawthon PM, McLean RR, Harris TB, Ferrucci L, Guralnik JM, Fragala MS, Kenny AM, Kiel DP, Kritchevsky SB, Shardell MD, Dam TT, Vassileva MT. The FNIH sarcopenia project: rationale, study description, conference recommendations, and final estimates. J Gerontol A Biol Sci Med Sci. 2014 May;69(5):547-58. doi: 10.1093/gerona/glu010.
- 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.
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 Chronic Kidney Disease and Sarcopenia, 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 12 inclusion and 12 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: opening soon, as of the sponsor's last update on 2 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Subrata Debnath, PhD (210-567-4700, nath@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal muscle strength (handgrip strength test) (time frame: Baseline to 14 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07437053, which also lists 13 linked publications.
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 2 Nov 2026.