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:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2025-12-24 @ 10:18 PM
NCT ID:
NCT03535935
Eligibility Criteria:
Inclusion Criteria:
* diagnosed with type 2 diabetes for at least 5 years;
* with an estimated glomerular filtration rate (GFR) ≥30 ˂90 mL/min/1.73m2 confirmed with repeat testing over three or more months calculated by the abbreviated MDRD study equation;
* persistent macroalbuminuria with spot urine albumin-to-creatinine ratio (UACR) ≥ 300 mg/g confirmed by at least 2 out of 3 consecutive first morning void urine samples;
* on stable dose of anti-diabetic drug including insulin for 12 weeks;
* on stable dose of angiotensin-converting-enzyme inhibitor or angiotensin receptor blocker for 12 weeks; and
* willing and able to give written informed consent
Exclusion Criteria:
* with known history of glomerulonephritis, polycystic kidney disease, systemic lupus erythematosus, any suggestive evidence of nondiabetic glomerulopathy;
* with known history of kidney transplant;
* with concurrent severe disorders of heart, brain, liver, and hematopoietic system, tumor and mental disorder;
* with deranged liver function;
* poorly controlled blood pressure;
* with known history of intolerance or malabsorption of oral medications;
* with uncontrollable urinary infection;
* experiencing pregnancy; or
* participating in other clinical trial within 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
80 Years
Study:
NCT03535935
Study Brief:
Protocol Section:
NCT03535935