Effect of Very Low Protein Diet Supplemented With Ketoanalogues of the Essential Amino Acids on the Progression of Chronic Kidney Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Primary composite endpoint
研究概览
简要总结
This is a prospective single center randomized controlled trial with a total duration of 18 months aiming to evaluate the effectiveness and the safety of a very low protein diet supplemented with ketoanalogues of essential aminoacids in reducing the progression of chronic kidney disease (CKD) in patients with advanced CKD.
详细描述
All eligible patients who will give informed consent will be screened. Those meeting the selection criteria will be enrolled and will enter a 3-month run-in phase during which a conventional LPD will be prescribed in all patients.
At the end of this phase, the subjects still fulfilling all the selection criteria will be randomized in a 1:1 ratio to receive the KD or to continue the conventional LPD for a total duration of 15 months.
Nineteen blood and urine samplings are scheduled for each patient, to be drawn monthly. The laboratory reports include the nitrogen compounds, calcium-phosphorus metabolism parameters, acid-base balance, biochemical nutritional markers, serum C-reactive protein, hemoglobin, blood cell count, and biochemical safety parameters (sodium, potassium, liver enzymes, and bilirubin).
The anthropometric measurements and subjective global assessment will be evaluated at enrolment, at randomization, and every 3 months thereafter.
The compliance with the prescribed diet (protein and energy intake) will be assessed monthly during the run-in phase, weekly for the first month after randomization, every 4 weeks during the next 6 months, and every 3 months thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult non-diabetic patients
- •stage 4-5 CKD not on dialysis (estimated glomerular filtration by Modification of Diet in Renal Disease formula < 30 mL/min per year
- •stable renal function at least 12 weeks before enrollment
- •well-controlled arterial blood pressure
- •proteinuria less than 1 g/g urinary creatinine
- •good nutritional status
- •declared and anticipated good compliance with the prescribed diet
排除标准
- •poorly controlled arterial blood pressure (≥145/85 mm Hg)
- •relevant comorbid conditions (diabetes mellitus, heart failure, active hepatic disease, digestive diseases with malabsorption, inflammation/anti-inflammatory therapy)
- •uremic complications (pericarditis, polyneuropathy)
- •feeding inability (anorexia, nausea)
结局指标
主要结局
Primary composite endpoint
时间窗: 15 months after randomization
Need for renal replacement therapy or an at least 50% reduction in the estimated glomerular filtration rate compared to randomization
次要结局
- Nutritional status - biochemical marker(18 weeks after enrolment)
- Secondary safety parameter - withdrawals(18 weeks after enrolment)
- Inflammation(18 weeks after enrolment)
- Safety parameter - adverse events(18 weeks after enrolment)
- Secondary outcome measure - nitrogen balance(15 months after randomization)
- Secondary efficacy parameter - mineral metabolism(15 weeks after randomization)
- Secondary safety parameter - anthropometric measures(18 weeks after enrolment)
- Secondary outcome measure - Nutritional status(18 weeks after enrolment)
- Nutritional status - biochemical markers(18 weeks after enrolment)
- Secondary efficacy parameter(15 weeks after randomization)
- Secondary safety parameter(18 weeks after enrolment)
研究者
Liliana Garneata
Assistant Professor of Nephrology, MD, PhD
Carol Davila University of Medicine and Pharmacy