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 @ 7:01 PM
Ignite Modification Date:
2025-12-24 @ 7:01 PM
NCT ID:
NCT01440257
Eligibility Criteria:
Key Inclusion Criteria:
* Aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (per American Diabetes Association \[ADA\] criteria), and treated with oral antidiabetic drugs
* Albumin:creatinine ratio (ACR) of 200 to 3000 mg/g creatinine, inclusive, based on two values obtained from two first morning urine samples taken on two separate days during the screening period
* Estimated glomerular filtration rate based on serum creatinine (eGFR, determined by Modification of Diet in Renal Disease \[MDRD\] equation) of ≥ 25 mL/min/1.73 m(2)
* Must be on a stable dose of an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) for at least 8 weeks prior to screening
* Fasting plasma glucose less than 270 mg/dL at screening
Key Exclusion Criteria:
* Type 1 diabetes mellitus or history of diabetic ketoacidosis
* Previous renal transplant or known non-diabetic renal disease, except related to hypertension
* Undergone renal dialysis at any time in the past
* Received chronic (more than 7 days continuously) systemic glucocorticoid or other immunosuppressive treatment within 8 weeks of screening
* Use of bardoxolone, atrasentan or other endothelin antagonist within 8 weeks of screening
* Received chronic (more than 7 days continuously) non-steroidal anti-inflammatory drug (NSAID) treatment within 2 weeks of screening
* Cardiac failure (class III or IV), history of unstable angina, symptomatic coronary artery disease, myocardial infarction or stroke within 12 weeks of screening
* Poorly-controlled blood pressure (systolic blood pressure \>155 or diastolic blood pressure \>95, with blood pressure measured in the seated position after at least 5 minutes of rest)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01440257
Study Brief:
Protocol Section:
NCT01440257