Sarcopenia in Chronic Kidney Disease (CKD) Patients

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.