Diabetes Mellitus, Type 2, Diabetic Nephropathies, Nephropathy, Diabetic
Conditions
Brief summary
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.
Interventions
DRUGAPX-115
oral administration of APX-115 400mg capsule once daily for 12 weeks
DRUGPlacebo
oral administration of APX-115-matching placebo 400mg capsule once daily for 12 weeks
Sponsors
Aptabio Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in urine albumin to creatinine ratio (UACR) in APX-115 group compared to placebo group | week 12 |
Countries
Bulgaria, Czechia, Hungary, Serbia
Outcome results
None listed