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 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT01968668
Eligibility Criteria:
Inclusion Criteria:
* Japanese subjects with type 2 diabetes mellitus and a clinical diagnosis of DN (Diabetic Nephropathy) treated with at least the minimal recommended dose of an Angiotensin Converting Enzyme Inhibitor (ACEI) and/or Angiotensin Receptor Blocker (ARB)
* Subjects with a clinical diagnosis of Diabetic Nephropathy (DN) based on at least 1 of the following criteria:
* Persistent very high albuminuria defined as Urinary Albumin to Creatine Ratio (UACR) of \>/=300 mg/g (\>/=34 mg/mmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) \>/=30 mL/min/1.73 m2 but \<90 mL/min/1.73 m2 Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) or
* Persistent high albuminuria defined as UACR of \>/=30 mg/g but \<300 mg/g (\>/=3.4 mg/mmol but \<34 mg/mmol) in 2 out of 3 first morning void samples and eGFR\>/=30 mL/min/1.73 m2 but \<90 mL/min/1.73 m2 (CKD-EPI)
* Serum potassium \</=4.8 mmol/L at both the run-in visit and the screening visit
Exclusion Criteria:
* Non-diabetic renal disease (confirmed by biopsy)
* Known bilateral clinically relevant renal artery stenosis (\>75%)
* Glycated hemoglobin(HbA1c) \>12% at the run-in visit or the screening visit
* UACR \>3000 mg/g (339 mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit
* Hypertension with mean sitting systolic blood pressure (SBP) \>/=180 mmHg or mean sitting diastolic blood pressure (DBP) \>/=110 mmHg at the run-in visit or mean sitting SBP \>/=160 mmHg or mean sitting DBP \>/=100 mmHg at the screening visit
* Subjects with a clinical diagnosis of heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the run-in visit
* Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01968668
Study Brief:
Protocol Section:
NCT01968668