Ketoanalogue Supplementation for Muscle Protection in CKD 4 and 5 Patients With Moderately Low Protein Diet

What this Trial Is About

Chronic kidney disease (CKD) is a growing public health concern, especially in advanced stages 4 and 5. High protein intake can worsen kidney function, leading to end-stage kidney disease. Recent guidelines recommend a moderate protein intake between 0.6 and 0.8 grams per kilogram of body weight per day for CKD patients, aiming to prevent muscle loss and preserve kidney function. This study evaluates whether supplementing with keto acid analogues (KA) along with a moderately low protein diet can protect muscle mass in patients with CKD stages 4 and 5. Participants will be randomly assigned to one of two groups. One group will follow current dietary practice with a target protein intake of 0.6 to 0.8 g/kg/day (half animal and half plant protein) and receive KA supplements dosed at one tablet per 10 kg of body weight. The control group will follow the same protein intake guidelines without KA supplementation. Both groups aim for a total energy intake of 25-35 kcal/kg/day. The study is designed to compare muscle mass preservation between these approaches over 12 months. During the study, participants' muscle mass will be measured using DEXA scans at 12 months to assess the primary outcome. Researchers will also monitor dietary protein intake and other health parameters. The study includes adults aged 18 to 100 years with advanced CKD without kidney replacement therapy. Safety and adherence will be observed throughout the trial, which is sponsored by the University Hospital, Clermont-Ferrand, and planned to run until January 2030.

Ketoanalogue Supplementation for Muscle Protection in CKD 4 and 5 Patients With Moderately Low Protein Diet (KETO-PROT-ACTION)