RICE study 2

JRCT ID: jRCTs031190063

Registered date:26/07/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic kidney disease
• Date of first enrollment: 10/09/2019
• Target sample size: 150
• Study type: Interventional
• Intervention(s): Protein restriction diet therapy (0.7 g/kg standard body weight/day) with low-protein rice or not

Outcome(s)

• Primary Outcome: Changes of creatinine clearance from baseline at 120 weeks

Secondary Outcome

1) Event free survival (EFS) with renal composite events with renal replacement therapy and 50% reduction of creatinine clearance up to 120 weeks
2) Changes of eGFR using cystatin C from baseline at 120 weeks
3) Changes of estimated protein intake per ideal body weight from the baseline at 120 weeks
4) Changes of physical measurement (Body weight, BMI, walking speed (6 m), grip strength, calf circumference, chair stand test (30 seconds)) results from the baseline at 120 weeks
5) Changes of body composition results from the baseline at 120 weeks
6) Changes of prescribed medicines from the baseline at 120 weeks
7) Period until it becomes positive for sarcopenia screening test

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Narita Ichiei
• Secondary Sponsor: Michihiro Hosojima
• Source(s) of Monetary Support: Kameda Seika Co.,Ltd., Biotech Japan Corporation, Forica Foods Co.,Ltd., Sato Foods Industries Co.,Ltd.