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 @ 1:01 AM
Ignite Modification Date:
2025-12-25 @ 1:01 AM
NCT ID:
NCT00913393
Eligibility Criteria:
Key Inclusion Criteria:
1. Signed written informed consent
2. Males and females 18-75 years of age, inclusive
3. Diagnosis of type 2 diabetes mellitus according to American Diabetes Association (ADA) criteria
4. 24-hour urinary ACR 200-3000 mg/g, inclusive, on two occasions during screening at least 2 days apart
5. Estimated glomerular filtration rate (eGFR) (by MDRD equation) \>20 mL/min/1.73 m2
6. Mean systolic blood pressure less than or equal to 150 mmHg and a mean diastolic blood pressure less than or equal to 95 mmHg
7. Receiving ACEi and/or ARB therapy at an unchanged dose at or above the minimum trial dosage for at least 3 months prior to the first Screening visit and willing to maintain these doses throughout the treatment period
Key Exclusion Criteria:
1. Females who are pregnant or breast feeding
2. Organ transplant recipient, history of dialysis, or known non-diabetic renal disease other than benign cysts or anatomical variants
3. History of New York Heart Association class III/IV heart failure
4. Screening electrocardiogram showing acute and/or clinically significant findings including but not limited to ST depression
5. History of any of the following events within 3 months prior to Screening: coronary artery bypass graft, cerebrovascular accident, myocardial infarction, transient ischemic attack, unstable angina, uncontrolled cardiac arrhythmia, atrial fibrillation, percutaneous coronary intervention, or vascular stent placement
6. History of anaphylactic or systemic allergic reaction to human, humanized, chimeric, or murine monoclonal antibodies
7. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>2.5 times the upper limit of normal; direct bilirubin above the upper limit of normal, or \>2.5 times the upper limit of normal in cases of documented Gilbert's syndrome
8. Hemoglobin \<10 g/dL
9. Hemoglobin A1c (HbA1c) \>9 %
10. Low density lipoprotein (LDL) \>130 mg/dL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00913393
Study Brief:
Protocol Section:
NCT00913393