JPRN-jRCTs031190063招募中未知
Randomized, multicenter, controlled study for the efficacy of low-protein rice diet in patients with chronic kidney disease
arita Ichiei0 个研究点目标入组 150 人开始时间: 2019年7月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •1) Outpatients whose age is 20 years or older and 75 years old or less at the time of consent acquisition
- •2) CKD stages from G3aA2 to G4 in the KDIGO category
- •3) Those who have not received renal replacement therapy for half a year and are not planning to begin renal replacement therapy for at least half a year from now
- •4) Body mass index of 18.5 kg/m2 or more and less than 30 kg/m2
- •5) Those who meet the above criteria 1) to 4), and those whose creatinine clearance 15 mL/min/1.73m2 or more, and less than 60 mL/min/1.73m2 conducted within 180 days of gaving written informed consent
- •6) Those who have given written informed consent on the use of their data for the study
排除标准
- •1) Those who have used staple foods of low protein for the past 3 months
- •2) Those who have been recipient on kidney transplantation or who are scheduled to be a recipient of kidney transplantation
- •3) Those with systolic blood pressure exceeding 160 mmHg or diastolic blood pressure exceeding 90 mmHg
- •4) Those with diabetes with HbA1c> 9.0%
- •5) Those with nephrotic syndrome (nephrotic syndrome is defined as a sustained urinary protein > 3.5 g/gCr and serum albumin level < 3.0 g/dL)
- •6) Those with serum albumin level < 3.0 g/dL
- •7) Those with congestive heart failure classified as Class III or IV cardiac function classification in New York Heart Association (NYHA)
- •8) Those with gastrointestinal disorders with malabsorption
- •9) Those with active liver disease
- •10) A pregnant woman, a lactating woman, or female patients who wishes to have a baby
- •11) Those who have been diagnosed and treated to malignant tumors within the past 5 years (excluding basal cell carcinoma of the skin or carcinoma in the uterine cervix which was surgically resected)
- •12) Those who are received the treatment of biologics or taking steroids for renal or inflammatory disease over 3 months (in case of prednisolone, exceeding 5mg)
- •13) Starved condition, irregular dietary intake, shortage or weakened dietary intake, excessive alcohol intake
- •14) Those who are participating in other trials
- •15) The grip strength test is less than 26 kg for men, less than 18 kg for female, or when it takes more than 15 seconds for chair stand test (5 times) (When SARC-F test is performed as screening and total score is 4 or more, grip strength test and chair stand test (5 times) will be performed)
- •16) Those who are considered not eligible for the study by attending doctors due to any medical reasons
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