Sarcopenia in Chronic Kidney Disease (CKD) Patients

NCT07437053 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: STUDY00002368P30AG044271
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Kidney Disease; Sarcopenia

Keywords

Valine; Essential amino acid; Metabolic effects

Outcome Measures

Primary Outcomes (4)

• 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

  Baseline to 14 weeks

• Muscle mass

  Change from baseline muscle mass using a bioelectrical impedance analysis to the end of each 6-Week intervention

  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

  Baseline to 14 weeks

• Incidence of patient-reported symptoms

  Change from baseline (number of symptoms) to the end of each 6-Week intervention

  Baseline to 14 weeks

Secondary Outcomes (1)

• Functional Assessment of Anorexia/Cachexia Therapy (FAACT) Anorexia subscale

  Baseline to 14 weeks

Other Outcomes (1)

• Serum Cystatin C-based eGFR

  Baseline to 14 weeks

Study Arms (2)

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.

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).

Drug: EEA

Interventions

Valine DRUG

A medical food intended for use under medical supervision

Also known as: Valine Amino Acid Supplement

Treatment group Valine

EEA DRUG

A medical food intended for use under medical supervision

Also known as: Essential Amino Acid Supplement

Treatment group EEA

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (13)

• 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.

  PMID: 38263952 RESULT

• Alvestrand 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.

  PMID: 7151348 RESULT

• Ikizler 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.

  PMID: 32829751 RESULT

• Jiang 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.

  PMID: 36594428 RESULT

• Laidlaw 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.

  PMID: 8154485 RESULT

• Wu 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.

  PMID: 39084052 RESULT

• Tizianello 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.

  PMID: 6588248 RESULT

• Block 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.

  PMID: 6727655 RESULT

• Burns 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.

  PMID: 707331 RESULT

• Masud 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.

  PMID: 8007590 RESULT

• Sunsandee 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.

  PMID: 40381110 RESULT

• Studenski 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.

  PMID: 24737557 RESULT

• Bhasin 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.

  PMID: 32150289 RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Sarcopenia

Interventions

Valine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Subrata Debnath, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Subrata Debnath, PhD

CONTACT

210-567-4700; nath@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study design will consist of a single center, prospective, randomized crossover open label pilot study

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data may be available beginning 1 year after the end of the trial and publication of the primary outcomes, and will be available for 24 months.
• Access Criteria: Data may be available to researchers who provide a methodologically sound proposals. Proposals should be directed to the principal investigator. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)