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

Sponsor
Aptabio Therapeutics, Inc. (Other)
Overall Status
Completed
CT.gov ID
NCT04534439
Collaborator
(none)
140
Enrollment
16
Locations
2
Arms
12
Actual Duration (Months)
8.8
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 24, 2020
Actual Primary Completion Date :
Jul 26, 2021
Actual Study Completion Date :
Aug 23, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Mean change in urine albumin to creatinine ratio (UACR) in APX-115 group compared to placebo group [week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pleven Pleven Bulgaria
2 Sveta Karidad Plovdiv Bulgaria
3 Diagnostic-consultative centre I Sliven Bulgaria
4 Hadzhi Dimitar Sofia Bulgaria
5 HERA Sofia Bulgaria
6 Medical center - Sveti Dimitar Sofia Bulgaria
7 Sirtuin Sofia Bulgaria
8 Sveta Sofia Bulgaria
9 Hristo Botev Vratsa Bulgaria
10 Sveti Panteleymon Yambol Yambol Bulgaria
11 Nefromed s.r.o Praha Czechia
12 Drug Research Center Balatonfüred Hungary
13 UNO MEDICAL Trials Kft. Budapest Hungary
14 Mint House Private Medical Center Székesfehérvár Hungary
15 Bezanijska Kosa Belgrade Serbia
16 Clinical Centre of Serbia, clinic for endocrinology, diabetes and metabolism diseases, department for obesity, metabolic and reproductive disorders Belgrade Serbia

Sponsors and Collaborators

  • Aptabio Therapeutics, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aptabio Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT04534439
Other Study ID Numbers:
  • A01-115-02-EU
  • 2019-004155-37
First Posted:
Sep 1, 2020
Last Update Posted:
Aug 25, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Aug 25, 2021