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

Phase 2

Completed

• Conditions: Nephropathy, Diabetic; Diabetic Nephropathies; Diabetes Mellitus, Type 2
• Interventions: Drug: APX-115; Drug: Placebo

• Registration Number: NCT04534439
• Lead Sponsor: Aptabio Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-24
• Study First Submitted: 2020-08-27
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-09-01
• Primary Completion: 2021-07-26
• Status Verified: 2021-08
• Study Completion: 2021-08-23
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
APX-115	APX-115	Oral administration of APX-115 400mg, daily
Placebo	Placebo	Oral administration of APX-115-matching placebo 400mg, daily

Primary Outcome Measures

Name	Time	Method
Mean change in urine albumin to creatinine ratio (UACR) in APX-115 group compared to placebo group	week 12

Trial Locations

Locations (16)

Hadzhi Dimitar; 🇧🇬 Sofia, Bulgaria

Pleven; 🇧🇬 Pleven, Bulgaria

Diagnostic-consultative centre I; 🇧🇬 Sliven, Bulgaria

Sveta Karidad; 🇧🇬 Plovdiv, Bulgaria

Medical center - Sveti Dimitar; 🇧🇬 Sofia, Bulgaria

Sirtuin; 🇧🇬 Sofia, Bulgaria

Sveta; 🇧🇬 Sofia, Bulgaria

HERA; 🇧🇬 Sofia, Bulgaria

Hristo Botev; 🇧🇬 Vratsa, Bulgaria

UNO MEDICAL Trials Kft.; 🇭🇺 Budapest, Hungary

Nefromed s.r.o; 🇨🇿 Praha, Czechia

Sveti Panteleymon Yambol; 🇧🇬 Yambol, Bulgaria

Drug Research Center; 🇭🇺 Balatonfüred, Hungary

Bezanijska Kosa; 🇷🇸 Belgrade, Serbia

Mint House Private Medical Center; 🇭🇺 Székesfehérvár, Hungary

Clinical Centre of Serbia, clinic for endocrinology, diabetes and metabolism diseases, department for obesity, metabolic and reproductive disorders; 🇷🇸 Belgrade, Serbia