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

Aptabio Therapeutics

Status and phase

Completed

Phase 2

Conditions

Diabetic Nephropathies

Nephropathy, Diabetic

Diabetes Mellitus, Type 2

Treatments

Drug: Placebo

Drug: APX-115

Study type

Interventional

Identifiers

NCT04534439

A01-115-02-EU

2019-004155-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

140 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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