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Clinical Trials/JPRN-jRCTs031190063
JPRN-jRCTs031190063
Recruiting
未知

Randomized, multicenter, controlled study for the efficacy of low-protein rice diet in patients with chronic kidney disease

arita Ichiei0 sites150 target enrollmentJuly 26, 2019

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
arita Ichiei
Enrollment
150
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 26, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
arita Ichiei

Eligibility Criteria

Inclusion 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

Exclusion 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

Outcomes

Primary Outcomes

Not specified

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