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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04534439
• Other study ID #: A01-115-02-EU
• Secondary ID: 2019-004155-37
• Status: Completed
• Phase: Phase 2
• Start date: August 24, 2020
• Est. completion date: August 23, 2021

Study information

• Verified date: August 2021
• Source: Aptabio Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 23, 2021
• Est. primary completion date: July 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Kidney Diseases
• Nephropathy, Diabetic

Intervention

Drug:
• APX-115
oral administration of APX-115 400mg capsule once daily for 12 weeks
• Placebo
oral administration of APX-115-matching placebo 400mg capsule once daily for 12 weeks

Locations

Country	Name	City	State
Bulgaria	Pleven	Pleven
Bulgaria	Sveta Karidad	Plovdiv
Bulgaria	Diagnostic-consultative centre I	Sliven
Bulgaria	Hadzhi Dimitar	Sofia
Bulgaria	HERA	Sofia
Bulgaria	Medical center - Sveti Dimitar	Sofia
Bulgaria	Sirtuin	Sofia
Bulgaria	Sveta	Sofia
Bulgaria	Hristo Botev	Vratsa
Bulgaria	Sveti Panteleymon Yambol	Yambol
Czechia	Nefromed s.r.o	Praha
Hungary	Drug Research Center	Balatonfüred
Hungary	UNO MEDICAL Trials Kft.	Budapest
Hungary	Mint House Private Medical Center	Székesfehérvár
Serbia	Bezanijska Kosa	Belgrade
Serbia	Clinical Centre of Serbia, clinic for endocrinology, diabetes and metabolism diseases, department for obesity, metabolic and reproductive disorders	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
Aptabio Therapeutics, Inc.

Countries where clinical trial is conducted

Bulgaria,  Czechia,  Hungary,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in urine albumin to creatinine ratio (UACR) in APX-115 group compared to placebo group		week 12