Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT02378194
Eligibility Criteria:
Inclusion Criteria:
1. Patient diagnosed with chronic renal failure which subjected to conservation therapy.
2. Patient has 15\~59mL/min/1.736m2 glomerular filtration rate.
3. Serum creatinine(sCr) is in the range of 1.5\~5.0mg/dL at the start of the test and until the start of the test from 52 weeks the serum creatinine is three times more than the number of measurements, and during the final test values of serum creatinine patients with advanced value rises 0.2mg/dL or higher than the first tests.
4. From the start of the test until 52 weeks before the test, serum creatinine the slope of the straight line for the inverse of the value is less than the rare patient -0.0001
5. Inpatient or outpatient
6. Age: 20\~75, gender: both
Exclusion Criteria:
1. Patient who start treatment drug or diet that maybe inhibit progress of renal failure within 3 months of the study start
2. Diabetic patients with unstable blood sugar regulation.
3. Patient did not have blood pressure control
4. Patient taking the combination of prohibited substances
5. Dialysis patient
6. Patient with gout
7. Patient who merged with a progressive muscular dystrophy, polymyositis, etc.
8. Patients with symptoms of cerebral vascular disorders
9. Women who are pregnant or breast-feeding
10. Patient with infectious disease
11. Patient with gastric ulcer
12. Patients who has difficult diet, medication, etc.
13. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
14. Subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT02378194
Study Brief:
Protocol Section:
NCT02378194