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

Primary Purpose

Diabetic Nephropathies, Diabetes Mellitus, Type 2, Nephropathy, Diabetic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
APX-115
Placebo
Sponsored by
Aptabio Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathies

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

APX-115

Placebo

Arm Description

Oral administration of APX-115 400mg, daily

Oral administration of APX-115-matching placebo 400mg, daily

Outcomes

Primary Outcome Measures

Mean change in urine albumin to creatinine ratio (UACR) in APX-115 group compared to placebo group

Secondary Outcome Measures

Full Information

First Posted
August 27, 2020
Last Updated
August 23, 2021
Sponsor
Aptabio Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04534439
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 24, 2020 (Actual)
Primary Completion Date
July 26, 2021 (Actual)
Study Completion Date
August 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aptabio Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathies, Diabetes Mellitus, Type 2, Nephropathy, Diabetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
APX-115
Arm Type
Experimental
Arm Description
Oral administration of APX-115 400mg, daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral administration of APX-115-matching placebo 400mg, daily
Intervention Type
Drug
Intervention Name(s)
APX-115
Intervention Description
oral administration of APX-115 400mg capsule once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral administration of APX-115-matching placebo 400mg capsule once daily for 12 weeks
Primary Outcome Measure Information:
Title
Mean change in urine albumin to creatinine ratio (UACR) in APX-115 group compared to placebo group
Time Frame
week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Istavan Wittmann, MD
Organizational Affiliation
University of Pecs
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pleven
City
Pleven
Country
Bulgaria
Facility Name
Sveta Karidad
City
Plovdiv
Country
Bulgaria
Facility Name
Diagnostic-consultative centre I
City
Sliven
Country
Bulgaria
Facility Name
Hadzhi Dimitar
City
Sofia
Country
Bulgaria
Facility Name
HERA
City
Sofia
Country
Bulgaria
Facility Name
Medical center - Sveti Dimitar
City
Sofia
Country
Bulgaria
Facility Name
Sirtuin
City
Sofia
Country
Bulgaria
Facility Name
Sveta
City
Sofia
Country
Bulgaria
Facility Name
Hristo Botev
City
Vratsa
Country
Bulgaria
Facility Name
Sveti Panteleymon Yambol
City
Yambol
Country
Bulgaria
Facility Name
Nefromed s.r.o
City
Praha
Country
Czechia
Facility Name
Drug Research Center
City
Balatonfüred
Country
Hungary
Facility Name
UNO MEDICAL Trials Kft.
City
Budapest
Country
Hungary
Facility Name
Mint House Private Medical Center
City
Székesfehérvár
Country
Hungary
Facility Name
Bezanijska Kosa
City
Belgrade
Country
Serbia
Facility Name
Clinical Centre of Serbia, clinic for endocrinology, diabetes and metabolism diseases, department for obesity, metabolic and reproductive disorders
City
Belgrade
Country
Serbia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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