Efficacy and Safety Study of Isuzinaxib in Subjects With DKD

ConditionDiabetic Kidney Disease (DKD)

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age19+

SponsorAptabio Therapeutics, Inc.

About this trial

This study is a multicenter, double-blinded, randomized, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, PK, and efficacy of Isuzinaxib compared with placebo in subjects with DKD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male/female subject aged ≥19 years inclusive at the time of informed consent.

Clinical diagnosis of type 2 diabetes and DKD.

18.5 kg/m² < body mass index < 35 kg/m².

Stable UACR values prior to screening visit.

Disqualifiers

History of type 1 diabetes mellitus or gestational diabetes.

Subject's renal impairment and/or albuminuria is considered to be of origin other than DKD.

History of renal transplant and/or plan to undergo a renal transplant during the study.

History of acute kidney injury or renal dialysis.

Trial design

Design model

Parallel

Treatments tested in this trial

Isuzinaxib
Drug
Oral dosing regimen once daily
Placebo
Drug
Oral dosing regimen once daily

Treatment groups

186 Participants

are divided into 3 treatment groups

Group A: Isuzinaxib 400 mgActive comparator 1 intervention

Group B: Isuzinaxib 200 mgActive comparator 1 intervention

Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Efficacy endpoint: Urine Albumin-Creatinine Ratio

Change in Urine Albumin-Creatinine Ratio from baseline through Week 24 in the Isuzinaxib treatment groups versus the placebo group

Time frame

Over 24 Weeks

Secondary outcomes

Efficacy endpoint: eGFR

Change from baseline in the eGFR

Time frame

Over 24 Weeks

Efficacy endpoint: Urine Albumin-Creatinine Ratio

Change in Urine Albumin-Creatinine Ratio from baseline through Week 20 in the Isuzinaxib treatment groups versus the placebo group

Time frame

Over 20 Weeks

Efficacy endpoint: Urine Albumin-Creatinine Ratio decrease

Subjects with a percentage decrease in Urine Albumin-Creatinine Ratio

Time frame

Over 24 Weeks

Efficacy endpoint: Incidence of Composite Renal Outcome

Number of subjects with end-stage kidney disease, kidney-related death, or renal replacement therapy

Time frame

Over 24 Weeks

Other outcomes

Plasma Biomarkers

MCP-1

Time frame

Over 24 Weeks

Urinary Biomarkers

KIM-1, NGAL

Time frame

Over 24 Weeks

Locations20

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Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aptabio Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov

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