Chronic Kidney Disease Observational Database - Taiwan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 9
- 主要终点
- Primary composite endpoint: 50 % eGFR decline or renal replacement therapy [Time Frame: From inclusion to 2 years follow up]
研究概览
简要总结
The purpose of this study is to determine the effect of a ketoanalogue supplemented very low protein diet on eGFR decline in chronic kidney disease compared to a low protein diet (0.6 g/kg, LPD) or no protein restriction.
详细描述
An important part of care in chronic kidney disease is an adapted diet. Its most important aspect is protein restriction. The rationale for protein restriction is a reduction of uremic wastes. However, nutritional requirements for protein synthesis limit the maximum extent of protein restriction. To deal with these conflicting targets, a minimum protein intake supplemented with ketoanalogues of amino acids (supplemented very low protein diet, sVLPD) meets the protein needs while reducing uremic waste.
The aim of this explorative, observational study is to determine the effect of sVLPD on eGFR decline compared to a low protein diet (LPD) or no protein restriction.
Data collection The study uses only data from routine health care records. The transfer to the electronic case report form is done by center investigators.
Data entry is monitored monthly for completeness and plausibility. Missing or unusual data will be requested for completion or re-assessment.
In case of high loss to follow up (>10%), low follow up frequency (<90% of patients with <3 visits per year), or greater than 5% missing core data (age, gender, descent, height, weight, history of diabetes and hypertension, blood pressure, serum creatinin, dietary prescription, judgement of compliance), audit visits including source data verification and trainings may be done.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >=20 years
- •Diagnosis of chronic kidney disease stage 3b to 5 (non-dialysis) according to KDIGO1, i.e. GFR < 45 ml/min/1.73 m².
- •Regular dietetic consultancy (at least once a year) for patients with stages 4 and 5 (GFR < 30 ml/min/1.73m²) who are following a LPD or sVLPD.
- •Written informed consent according to local regulations
排除标准
- •Hypercalcemia
- •Disturbed amino acid metabolism, e.g. phenylketonuria
- •A kidney transplant
- •Sustained high blood pressure (inadequately controlled (>160 mmHg systolic or >110 mmHg diastolic) despite ≥3 antihypertensive medications)
- •Independent life-threatening disease(s), i.e. terminal cancer, AIDS, stage IV heart failure, end stage liver cirrhosis
- •Renal insufficiency caused by
- •Renal cancer
- •Genetic renal diseases, e.g. polycystic kidney disease, congenital nephrotic syndrome
- •Hypersensitivity to the active substances or to any of the excipients of the ketoanalogue supplement
- •Furthermore, pregnant and breast-feeding patients
结局指标
主要结局
Primary composite endpoint: 50 % eGFR decline or renal replacement therapy [Time Frame: From inclusion to 2 years follow up]
时间窗: 2 years
Primary composite endpoint \[Time Frame: From inclusion/Patient enrolment to 2 years follow up\]. Need for renal replacement therapy or an at least 50% reduction in the estimated glomerular filtration rate (eGFR) compared to time of patient inclusion into the study and after 2 years
次要结局
- Prescribed diet(2 years)
- Impact of compliance to prescribed protein diet on the eGRF decline(2 years)