NCT04534439

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_2

Geographic Reach
4 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 24, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2021

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

August 27, 2020

Last Update Submit

August 23, 2021

Conditions

Diabetic NephropathiesDiabetes Mellitus, Type 2Nephropathy, Diabetic

Outcome Measures

Primary Outcomes (1)

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

    week 12

Study Arms (2)

APX-115

EXPERIMENTAL

Oral administration of APX-115 400mg, daily

Drug: APX-115

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

APX-115DRUG

oral administration of APX-115 400mg capsule once daily for 12 weeks

APX-115
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical Diagnosis of type 2 diabetes and nephropathy
  • First morning void (FMV) UACR between 200 and 3000 mg/g, inclusive
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Pleven

Pleven, Bulgaria

Location

Sveta Karidad

Plovdiv, Bulgaria

Location

Diagnostic-consultative centre I

Sliven, Bulgaria

Location

Hadzhi Dimitar

Sofia, Bulgaria

Location

HERA

Sofia, Bulgaria

Location

Medical center - Sveti Dimitar

Sofia, Bulgaria

Location

Sirtuin

Sofia, Bulgaria

Location

Sveta

Sofia, Bulgaria

Location

Hristo Botev

Vratsa, Bulgaria

Location

Sveti Panteleymon Yambol

Yambol, Bulgaria

Location

Nefromed s.r.o

Prague, Czechia

Location

Drug Research Center

Balatonfüred, Hungary

Location

UNO MEDICAL Trials Kft.

Budapest, Hungary

Location

Mint House Private Medical Center

Székesfehérvár, Hungary

Location

Bezanijska Kosa

Belgrade, Serbia

Location

Clinical Centre of Serbia, clinic for endocrinology, diabetes and metabolism diseases, department for obesity, metabolic and reproductive disorders

Belgrade, Serbia

Location

MeSH Terms

Conditions

Diabetic NephropathiesDiabetes Mellitus, Type 2

Interventions

isuzinaxib

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Istavan Wittmann, MD

    University of Pecs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2020

First Posted

September 1, 2020

Study Start

August 24, 2020

Primary Completion

July 26, 2021

Study Completion

August 23, 2021

Last Updated

August 25, 2021

Record last verified: 2021-08

Locations

CZ(1)HU(3)SE(2)BU(10)