2024-516764-29-00
Not yet recruiting
Phase 3
Ketoanalogue Supplementation for Muscle Protection in CKD 4 and 5 Patients with Moderately Low Protein Diet
CHU Gabriel-Montpied2 sites in 1 country100 target enrollmentStarted: January 13, 2025Last updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- CHU Gabriel-Montpied
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- 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.
Overview
Brief Summary
To determine the effect of Ketoanalogue supplementation on sarcopenia at 12 months in patients with stage 4 or 5 CKD and dietary protein intake between 0.6 and 0.8 g/kg/d
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men or women older than 18 years
- •Stage 4 or 5 Chronic Kidney Disease (CKD) (eGFR with CKD-EPI 2009 creatinine equation < 30 mL/min/m2)
- •Protein intake 0.6-0.8 g/kg/d (estimated with dietary survey)
- •patient with social security cover
- •Written informed consent
Exclusion Criteria
- •Hospitalization in the past 3 months
- •Patient under a legal protection (curatorship or tutorship)
- •Corticosteroids (> 7.5 mg/d), cytotoxic or immunosuppressive drugs
- •Severe symptomatic heart (NYHA 3 or 4) or liver failure (Child Pugh B or C)
- •Respiratory failure requiring oxygenotherapy
- •Ongoing infection, autoimmune disease or cancer
- •Pregnant (e.g., positive human chorionic gonadotrophin [HCG] test) or lactating patients
- •Patients with psychiatric or cognitive disorders rendering them unable to give written informed consent
- •Hypersensitivity to the active substances in Ketosteril
- •Hypercalcaemia
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Grip strength measured by dynamometry at 12 months
- Muscle performance evaluated by walking speed test over 4 meters at 12 months
- Serum Calcium and phosphate at 3, 6, 9 and 12 months
- Parathormone at 3, 6, 9 and 12 months
- 25OH Vitamin D2 + D3 at 12 months
- Bone mineral density measured by DEXA at 12 months
- Use and dosage of phosphate binders
- Time to renal replacement therapy start (or transplantation?)
- Estimated GFR using 2012 CKD EPI creatinine and cystatin C equation at 12 months
- Proteinuria at 12 months
- Weight and BMI at 3, 6, 12 months
- Concentration of albumin, prealbumin and CRP at 3, 6, 9 and 12 months
- Serum lipids and glycemia at 12 months
- Skin fold and mid arm muscle circumference
Investigators
Lise Laclautre
Scientific
CHU Gabriel-Montpied
Study Sites (2)
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