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 @ 7:40 PM
Ignite Modification Date:
2025-12-24 @ 7:40 PM
NCT ID:
NCT01756703
Eligibility Criteria:
Inclusion Criteria:
* Subjects with Type II diabetic nephropathy, who have been treated with angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin II receptor blocker (ARB)
* Glycosylated haemoglobin (HbA1c) ≤10.5%
* An estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m\^2
* Subject with albuminuria
Exclusion Criteria:
* History of Type I diabetes, pancreas or β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
* Serum potassium level \<3.5 or \>5.0 mmol/L
* Subjects who had acute kidney injury (AKI) within 3 months prior to baseline or have undergone renal dialysis at any time prior to randomisation
* Subjects with a history of renal transplant
* Subjects with clinically significant hypotension
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01756703
Study Brief:
Protocol Section:
NCT01756703