Ketoanalogue Supplementation for Muscle Protection in CKD 4 and 5 Patients With Moderately Low Protein Diet
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
- 1
- 主要终点
- Appendicular muscle mass measured by DEXA
研究概览
简要总结
Chronic kidney disease (CKD) complicates many pathologies and the rapid increase in its prevalence constitutes a major public health concern. Whatever the cause of kidney failure, high protein consumption is a factor of progression to end-stage kidney disease. A low-protein (0.6 g/kg/d) or a very low-protein (0.3 g/kg/d) diet associated with supplementation with amino acids and/or keto acid analogues (KA) slows down renal function deterioration and prolongs the time before dialysis start. Difficulties in strict protein restriction implementation limit its use to a minority of CKD patients and are difficult to implement in real life.
Recently KDOQI guidelines have recommended a dietary protein intake of 0.55 to 0.6 g/kg/d in CKD 3 to 5 non-diabetic patients "metabolically stable" and 0.6 to 0.8 g/kg/d in diabetic patients. However, the International Society of Renal Nutrition and Metabolism and the French guidelines about management of CKD propose to maintain a protein intake between 0.6 and 0.8 g/kg/d for all patients and as near as possible to 0.6 g/kg/d. This is because for a population, a mean value of 0.66 g/kg/d insures that 95% of patients are above 0.55 g/kg/d (the minimum requirement to avoid a negative nitrogen balance).
Experimental studies and few clinical studies suggest a protective effect of KA supplementation on uremic sarcopenia. Interestingly this effect is also observed in patients with a protein intake of 0.6 to 0.8 g/kg/d and with a dose of KA reduced by half compared to the dose used with VLPD. Moreover, in a preliminary study, we found a nephroprotective effect of KA (1 tablet/5kg body weight) in patients with an average dietary protein intake of 0.7 g/kg/d suggesting a specific effect of KA beyond protein restriction.
The hypothesis is therefore that KA treatment (1 tablet/10kg), together with a dietary protein intake between 0.6 and 0.8g/kg/d, prevent muscle mass loss in patients with stages 4 and 5 CKD. If these results were confirmed, this could expand the population that could benefit from KA supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women
- •Older than 18 years of age
- •Stage 4 or 5 CKD (eGFR with CKD-EPI 2009 creatinine equation < 30 mL/min/m2), whitout renal replacement therapy or kidney transplantation
- •Protein intake 0.6-0.8 g/kg/d (estimated with Moroni formula)
- •Social security cover
- •Written informed consent
排除标准
- •Hospitalization in the past 3 months
- •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
- •Risk of pregnancy: any woman who does not fulfil one of the following criteria:
- •post-menopausal (aged > 45 years with amenorrhea for more than 2 years, or of any age with amenorrhea for more than 6 months and an FSH level > 40 mUI / mL)
- •permanent sterilisation (e.g., occlusion/bilateral ligature of the fallopian tubes, hysterectomy, bilateral salpingectomy, bilateral ovariectomy) or constitutional sterility
- •of childbearing age and using an efficient method of contraception, begun at least 28 days before inclusion. Efficient contraception methods are: oral, injectable or implantable hormonal methods intra-uterine devices sterilisation of the male partner if he is the sole partner abstinence, if compatible with the preferred and usual lifestyle of the individual NB: if child bearing potential changes during the study, the woman must start taking one of the efficient methods of contraception as described above.
- •Patients with psychiatric or cognitive disorders rendering them unable to give written informed consent
- •Patients unwilling to participate in the study
- •Hypersensitivity to the active substances in Ketosteril®
- •Hypercalcaemia
- •Hypophosphatemia
- •Patient under a legal protection (curatorship or tutorship)
研究组 & 干预措施
Keto acid analog
Current practice + Keto acid analog (1 tablet / 10 kg body weight) Current practice: protein intake target of 0.6 g/kg/d in order to achieve a dietary protein intake of 0.6 to 0.8 g/kg/d (50% animal protein 50 % plant protein) and total energy intake of 25-35 kcal/kg/d.
干预措施: Keto Acid (Drug)
Control
Current practice: protein intake target of 0.6 g/kg/d in order to achieve a dietary protein intake of 0.6 to 0.8 g/kg/d (50% animal protein 50 % plant protein) and total energy intake of 25-35 kcal/kg/d.
结局指标
主要结局
Appendicular muscle mass measured by DEXA
时间窗: at 12 months
measured by DEXA
次要结局
未报告次要终点