Safety, Tolerability and Renal Effects of APX-115 in Subjects With Type 2 Diabetes and Nephropathy

A Randomized, Placebo-controlled, Double-blinded, Multi-centre, Phase 2 Study to Assess Safety, Tolerability and Renal Effects of APX-115 in Subjects With Type 2 Diabetes and Nephropathy

This is a proof of concept (PoC) trial to evaluate the safety, tolerability and renal effect of APX-115 in subjects with Type 2 diabetes and nephropathy.

Inclusion Criteria:

• Clinical Diagnosis of type 2 diabetes and nephropathy
• First morning void (FMV) UACR between 200 and 3000 mg/g, inclusive
• 30 mL/min/1.73m2 ≤ eGFR ≤ 90 mL/min/1.73m2 using CKD-EPI formula at screening
• HbA1c ≤ 10% at screening visit
• Subject who has been taking unchanged dosage of ACE inhibitor or ARB medication for at least 3 months prior to screening and is not anticipated to change its dosage during the course of the study
• Willing to be under dietary management for diabetes

Exclusion Criteria:

• History of type 1 diabetes mellitus or gestational diabetes
• Subject's renal impairment and/or albuminuria is considered to be of origin other than Diabetic Kidney Disease
• Subject with uncontrolled blood pressure
• Clinically significant abnormal laboratory findings
• History of any cardiovascular event within 6 months prior to screening or cardiovascular procedure planned during the clinical trial
• Diagnostic or interventional procedure requiring a contrast agent within 4 weeks before the screening visit or planned during the course of the study
• Clinically significant ECG abnormalities on a 12-lead ECG at the screening visit or before randomization
• Current or history of NYHA class IV heart failure