L-LYSINE ACETATE, L-TRYPTOPHAN, L-HISTIDINE, LYSINE ACETATE, L-THREONINE, L-TYROSINE, KETO-ISOLEUCINE CALCIUM, KETO-LEUCINE CALCIUM, KETO-VALINE CALCIUM, HYDROXI-METHIONINE CALCIUM, ALPHA-KETOPHENYLALANINE CALCIUM for Chronic kidney disease (stage 4 and 5)|Sarcopenia

Inclusion criteria

• {"criterion_text":"- Men or women older than 18 years"}
• {"criterion_text":"- Stage 4 or 5 Chronic Kidney Disease (CKD) (eGFR with CKD-EPI 2009 creatinine equation < 30 mL/min/m2)"}
• {"criterion_text":"- Protein intake 0.6-0.8 g/kg/d (estimated with dietary survey)"}
• {"criterion_text":"- patient with social security cover"}
• {"criterion_text":"- Written informed consent"}

Exclusion criteria

• {"criterion_text":"- Hospitalization in the past 3 months"}
• {"criterion_text":"- Patient under a legal protection (curatorship or tutorship)"}
• {"criterion_text":"- Corticosteroids (> 7.5 mg/d), cytotoxic or immunosuppressive drugs"}
• {"criterion_text":"- Severe symptomatic heart (NYHA 3 or 4) or liver failure (Child Pugh B or C)"}
• {"criterion_text":"- Respiratory failure requiring oxygenotherapy"}
• {"criterion_text":"- Ongoing infection, autoimmune disease or cancer"}
• {"criterion_text":"- Pregnant (e.g., positive human chorionic gonadotrophin [HCG] test) or lactating patients"}
• {"criterion_text":"- Patients with psychiatric or cognitive disorders rendering them unable to give written informed consent"}
• {"criterion_text":"- Hypersensitivity to the active substances in Ketosteril"}
• {"criterion_text":"- Hypercalcaemia"}

Primary endpoints

• {"endpoint_text":"- Muscle mass index measured by DEXA (appendicular lean mass kg/m²) at 12 months. Appendicular muscle mass is the sum of the lean muscle mass of the upper and lower extremities.","definition_or_measurement_approach":"Measured by DEXA; primary measure is appendicular lean mass (kg/m²). Appendicular muscle mass defined as sum of lean muscle mass of upper and lower extremities; assessed at 12 months."}

Secondary endpoints

• {"endpoint_text":"- Weight and BMI at 3, 6, 12 months","definition_or_measurement_approach":"Body weight and body mass index measured at 3, 6 and 12 months."}
• {"endpoint_text":"- Concentration of albumin, prealbumin and CRP at 3, 6, 9 and 12 months","definition_or_measurement_approach":"Serum concentrations of albumin, prealbumin and C-reactive protein measured at 3, 6, 9 and 12 months."}
• {"endpoint_text":"- Serum lipids and glycemia at 12 months","definition_or_measurement_approach":"Fasting serum lipid profile and blood glucose measured at 12 months."}
• {"endpoint_text":"- Skin fold and mid arm muscle circumference","definition_or_measurement_approach":"Anthropometric assessment including skinfold thickness and mid-arm muscle circumference (timepoints not explicitly stated)."}
• {"endpoint_text":"- Grip strength measured by dynamometry at 12 months","definition_or_measurement_approach":"Hand-grip strength assessed by dynamometer at 12 months."}
• {"endpoint_text":"- Muscle performance evaluated by walking speed test over 4 meters at 12 months","definition_or_measurement_approach":"4-meter walking speed test performed at 12 months to evaluate muscle performance."}
• {"endpoint_text":"- Serum Calcium and phosphate at 3, 6, 9 and 12 months","definition_or_measurement_approach":"Serum calcium and phosphate concentrations measured at 3, 6, 9 and 12 months."}
• {"endpoint_text":"- Parathormone at 3, 6, 9 and 12 months","definition_or_measurement_approach":"Serum parathormone (PTH) measured at 3, 6, 9 and 12 months."}
• {"endpoint_text":"- 25OH Vitamin D2 + D3 at 12 months","definition_or_measurement_approach":"Serum 25-hydroxyvitamin D2 and D3 measured at 12 months."}
• {"endpoint_text":"- Bone mineral density measured by DEXA at 12 months","definition_or_measurement_approach":"Bone mineral density assessed by DEXA at 12 months."}
• {"endpoint_text":"- Use and dosage of phosphate binders","definition_or_measurement_approach":"Recorded use and dosing of phosphate binders during the study (timepoints not specified)."}
• {"endpoint_text":"- Time to renal replacement therapy start (or transplantation?)","definition_or_measurement_approach":"Time-to-event endpoint measuring time to start of renal replacement therapy or transplantation."}
• {"endpoint_text":"- Estimated GFR using 2012 CKD EPI creatinine and cystatin C equation at 12 months","definition_or_measurement_approach":"Estimated glomerular filtration rate calculated using the 2012 CKD-EPI creatinine-cystatin C equation at 12 months."}
• {"endpoint_text":"- Proteinuria at 12 months","definition_or_measurement_approach":"Assessment of proteinuria at 12 months (method not further specified)."}

France

Earliest CTIS Part Ii Submission Date

18-10-2024

Latest Decision Or Authorization Date

13-01-2025

Processing Time Days

87

Number Of Sites

2

Number Of Participants

100

Primary sponsor

Full Name

CHU Gabriel-Montpied

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France