Recruiting

PROMISS-DKDIsuzinaxib for Diabetic Kidney Disease

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What is being tested

Isuzinaxib

+ Placebo

Drug
Who is being recruted

Urogenital Diseases+7

+ Diabetes Mellitus

+ Diabetic Nephropathies

Over 19 Years
+33 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: May 2025
See protocol details

Summary

Principal SponsorAptabio Therapeutics, Inc.
Study ContactSung Jun Lim
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 26, 2025

Actual date on which the first participant was enrolled.

This clinical trial is focused on evaluating a new treatment called Isuzinaxib for individuals suffering from Diabetic Kidney Disease (DKD). The study aims to assess the safety and effectiveness of the drug compared to a placebo, which is a substance with no active medication. Participants in the study are individuals diagnosed with DKD, a condition that affects kidney function due to diabetes. This research is important as it seeks to find a potentially effective treatment for improving kidney health and managing complications in people with diabetes. Participants in this study will receive either Isuzinaxib or a placebo, and the treatment will be administered in different doses to determine the most effective and safe amount. The trial is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication or the placebo, to ensure unbiased results. The study will monitor various aspects such as safety, how well participants tolerate the drug, and how the body processes it. By comparing these outcomes between the Isuzinaxib and placebo groups, researchers aim to gather valuable information that could lead to improved treatment options for diabetic kidney disease.

Official TitleA Phase 2b Randomized, Double-blind, Placebo-controlled, Dose-ranging, Multicenter Study to Evaluate the Efficacy and Safety of Isuzinaxib in Subjects With Diabetic Kidney Disease
NCT06962098
Principal SponsorAptabio Therapeutics, Inc.
Study ContactSung Jun Lim
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

186 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesDiabetes MellitusDiabetic NephropathiesEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesUrologic DiseasesDiabetes ComplicationsFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

12 inclusion criteria required to participate
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.
Show More Criteria
21 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Subject will receive the 200 mg of Isuzinaxib.

Group II

Active Comparator
Subject will receive the 400 mg of Isuzinaxib.

Group III

Placebo
Subject will receive the Placebo.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 20 locations

Recruiting

Korea University Ansan Hospital

Ansan-si, South KoreaOpen Korea University Ansan Hospital in Google Maps
Recruiting

Pusan National University Hospital

Busan, South Korea
Recruiting

SoonChunHyang University Hospital Cheonan

Cheonan, South Korea
Recruiting

Keimyung University Daegu Dongsan Hospital

Daegu, South Korea
Recruiting
20 Study Centers
PROMISS-DKD | Isuzinaxib for Diabetic Kidney Disease | PatLynk