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 @ 4:46 AM
Ignite Modification Date:
2025-12-25 @ 4:46 AM
NCT ID:
NCT01796418
Eligibility Criteria:
Inclusion Criteria:
* Aged 19 years or more and 75 years or less
* Type 2 diabetes who is prescribed glucose-lowering agent or insulin
* Estimated glomerular filtration rate (GFR) by isotope dilution mass spectrometry (IDMS)- Modification of Diet in Renal Disease (MDRD) equation 30 ml/min/1.73 m2 or more
* verified 2 times or more of albuminuria 30 mg/g cr (or protein 300 mg/g cr)or more in a spot urine sample with interval of 1 week or more in recent 6 months
* Patients whose blood pressure is 140/90 mmHg or less and did not receive a prescription for additional antihypertensive medication in recent 3 months
* Patients who give written consent to this study by oneself
Exclusion Criteria:
* History of kidney transplantation
* current advanced congestive heart failure (NYHA class III or more)
* current uncontrolled arrhythmia
* current advanced liver cirrhosis (Child-Pugh class C)
* History of bleeding diathesis
* current active infection or uncontrolled inflammatory disorders
* History of cerebrovascular accident or myocardial infarction
* current use of anticoagulant
* current use of two or more antiplatelet agents
* patients with advanced malignancy (life expectancy less than 6 months)
* patients with uncontrolled diabetes (Hba1c more than 10%)
* patients with severe anemia (Hb less than 8.0 g/dL)
* female who are pregnant, trying to get pregnant or lactating
* Genetic diseases such as galactose intolerance, lactose deficiency or glucose-galactose malabsorption
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT01796418
Study Brief:
Protocol Section:
NCT01796418