Sarcopenia in Chronic Kidney Disease (CKD) Patients

Официальное название

Branched-chain Amino Acids to Improve Sarcopenia in Patients With Advanced Chronic Kidney Disease (BOOST-CKD)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Valine
  A medical food intended for use under medical supervision
• Препарат EEA
  A medical food intended for use under medical supervision

Первичные конечные точки

• Skeletal muscle strength (handgrip strength test) [Срок оценки: Baseline to 14 weeks]
• Muscle mass [Срок оценки: Baseline to 14 weeks]
• Physical performance (4-meter Walk Gait Speed Test or 4MWT) [Срок оценки: Baseline to 14 weeks]
• Incidence of patient-reported symptoms [Срок оценки: Baseline to 14 weeks]

Вторичные конечные точки (1)

• Functional Assessment of Anorexia/Cachexia Therapy (FAACT) Anorexia subscale [Срок оценки: Baseline to 14 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at San Antonio — San Antonio

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07437053 · STUDY00002368 · P30AG044271

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗