Clinical trial NCT04534439: Safety, Tolerability and Renal Effects of APX-115 in Subjects With Type 2 Diabetes and Nephropathy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Nephropathies
Diabetes Mellitus, Type 2
Nephropathy, Diabetic
Lead sponsor: Aptabio Therapeutics, Inc.
Sponsor class: INDIV
First posted: 2020-09-01
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean change in urine albumin to creatinine ratio (UACR) in APX-115 group compared to placebo group
timeFrame: week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: Pleven
city: Plovdiv
country: Bulgaria
facility: Sveta Karidad
city: Sliven
country: Bulgaria
facility: Diagnostic-consultative centre I
city: Sofia
country: Bulgaria
facility: Hadzhi Dimitar
city: Sofia
country: Bulgaria
facility: HERA
city: Sofia
country: Bulgaria
facility: Medical center - Sveti Dimitar
city: Sofia
country: Bulgaria
facility: Sirtuin
city: Sofia
country: Bulgaria
facility: Sveta
city: Vratsa
country: Bulgaria
facility: Hristo Botev
city: Yambol
country: Bulgaria
facility: Sveti Panteleymon Yambol
city: Praha
country: Czechia
facility: Nefromed s.r.o
city: Balatonfüred
country: Hungary
facility: Drug Research Center
city: Budapest
country: Hungary
facility: UNO MEDICAL Trials Kft.
city: Székesfehérvár
country: Hungary
facility: Mint House Private Medical Center
city: Belgrade
country: Serbia
facility: Bezanijska Kosa
city: Belgrade
country: Serbia
facility: Clinical Centre of Serbia, clinic for endocrinology, diabetes and metabolism diseases, department for obesity, metabolic and reproductive disorders
Study officials:
affiliation: University of Pecs
name: Istavan Wittmann, MD
role: PRINCIPAL_INVESTIGATOR
References: