Ketoanalogue-supplemented Low Protein Diet and Deferring Dialysis in Patients With Severe Proteinuria and Advanced Diabetic Kidney Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- CKD progression
研究概览
简要总结
This is a prospective single center open label randomized controlled trial aiming to assess the effectiveness and safety of a low protein diet (0.6 g/kg-day, mainly vegetarian) supplemented with ketoanalogues of essential amino-acids (sLPD) as compared to a mild protein restriction (0.8 g/kg-day, MPD) in reducing Chronic Kidney Disease (CKD) progression, with a planned total duration is of 18 months.
Adult diabetic patients with CKD stage 4+ [estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease 4-variable (MDRD4) formula <30 mL/min per year], with stable renal function (historical reduction of eGFR of < 10 ml/min-year) , proteinuria > 3g/g creatininuria and good nutritional status (SGA A) will be enrolled.
详细描述
Adult diabetic patients with Chronic Kidney Disease (CKD) stage 4+ (estimated GFR using the Modification of Diet in Renal Disease 4-variable, MDRD4, formula <30 mL/min per year), with stable renal function (historical reduction of eGFR of < 10 ml/min-year), proteinuria > 3g/g creatininuria and good nutritional status (SGA A) will be enrolled. Patients with evidence of active kidney disease (except proteinuria), with indication of etiological or pathogenic treatment, those with poor control of diabetes (HbA1c >8%), those with uncontrolled high blood pressure (≥155/85 mmHg), those with significant co-morbidities (heart failure, active liver disease, malabsorption, active infections, inflammatory diseases requiring corticosteroids), those with uremic symptoms (pericarditis, digestive disorders ) or malnutrition (SGA B or C, serum albumin < 3.5 g/dl) will be excluded.
Eligible patients will enter a run-in phase (3 mo), when mild protein restriction (0.8g/kg dry ideal bw) will be initiated and compliance will be evaluated twice monthly.
Those who will prove compliant during the run-in phase and still fulfill the selection criteria will be randomized 1:1 (computer-generated numbers) to receive the low protein diet (0.6 g/kg-day, mainly vegetarian) supplemented with ketoanalogues of essential amino-acids (Ketosteril 1 tb/10 kg dry bw) or to continue the mild protein restriction (0.8 g/kg-day).
The total recommended energy intake is of 30 kcal/kg of ideal dry body weight per day in all patients.
The primary composite endpoint is the need for RRT initiation or a more than 50% reduction in the initial eGFR any time during the assessment phase. The decision to initiate RRT will be made by the Ethical Committee of the Hospital, based on the clinical and laboratory data.
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
- •diabetic patients
- •CKD stage 4+ (estimated GFR using the Modification of Diet in Renal Disease 4-variable, MDRD4, formula <30 mL/min per year)
- •stable renal function (historical reduction of eGFR of < 10 ml/min-year)
- •proteinuria > 3g/g creatininuria
- •good nutritional status (SGA A)
排除标准
- •evidence of active kidney disease (except proteinuria)
- •indication for etiological or pathogenic treatment
- •poor control of diabetes (HbA1c >8%)
- •uncontrolled high blood pressure (≥155/85 mmHg)
- •significant co-morbidities (heart failure, active liver disease, malabsorption, active infections, inflammatory diseases requiring corticosteroids)
- •uremic symptoms (pericarditis, digestive disorders
- •or malnutrition (SGA B or C, serum albumin < 3.5 g/dl)
结局指标
主要结局
CKD progression
时间窗: 15 months
Percentage of patients requiring RRT initiation or a more than 50% reduction in the initial eGFR at anytime during the study
次要结局
- Correction of nitrogen balance(monthly up to 15 months)
- Nutritional status - Subjective Global Assessment (SGA)(monthly up to 15 months)
- Serum albumin(monthly up to 15 months)
- Occurence of the adverse events(twice-a-month during the run-in phase, weekly for the first month after randomization, every 4 weeks during the next 6 months, and every 3 months up to 15 months)
- Middle arm muscular circumference (MAMC)(monthly up to 15 months)
- Inflammatory status(monthly up to 15 months)
- Correction of metabolic acidosis(monthly up to 15 months)
- Correction of calcium metabolism abnormalities(monthly up to 15 months)
- Correction of mineral metabolism abnormalities(monthly up to 15 months)
- Serum level of intact Parathyroid Hormone (iPTH)(monthly up to 15 months)
- Tricipital Skin Fold (TSF)(monthly up to 15 months)
- Serum cholesterol(monthly up to 15 months)
- Compliance to the protein intake(twice-a-month during the run-in phase, weekly for the first month after randomization, every 4 weeks during the next 6 months, and then every 3 months up to 15 months)
- Compliance to the energy intake(twice-a-month during the run-in phase, weekly for the first month after randomization, every 4 weeks during the next 6 months, and then every 3 months up to 15 months)
- Need for renal replacement therapy (RRT)(15 months)
- Patients' Quality of life(at baseline and than every 3 months up to 15 months)
- Decline in eGFR(monthly up to 15 months)
- Body Mass Index (BMI)(monthly up to 15 months)