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

August 23, 2021 updated by: Aptabio Therapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: APX-115
Oral administration of APX-115 400mg, daily
Drug: APX-115
oral administration of APX-115 400mg capsule once daily for 12 weeks
Placebo Comparator: Placebo
Oral administration of APX-115-matching placebo 400mg, daily
Drug: Placebo
oral administration of APX-115-matching placebo 400mg capsule once daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in urine albumin to creatinine ratio (UACR) in APX-115 group compared to placebo group
Time Frame: week 12
week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aptabio Therapeutics, Inc.

Investigators

  • Principal Investigator: Istavan Wittmann, MD, University of Pecs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2020

Primary Completion (Actual)

July 26, 2021

Study Completion (Actual)

August 23, 2021

Study Registration Dates

First Submitted

August 27, 2020

First Submitted That Met QC Criteria

August 27, 2020

First Posted (Actual)

September 1, 2020

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A01-115-02-EU
  • 2019-004155-37 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on APX-115

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe