2024-516764-29-00招募中3 期
Ketoanalogue Supplementation for Muscle Protection in CKD 4 and 5 Patients with Moderately Low Protein Diet
CHU Gabriel-Montpied2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月13日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
次要结局
- 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
研究者
Lise Laclautre
Scientific
CHU Gabriel-Montpied
研究点 (2)
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