RecruitingPhase 2

Efficacy and Safety Study of Isuzinaxib in Subjects With DKD

South Korea186 participantsStarted 2025-05-26

Plain-language summary

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.

Who can participate

Age range19 Years

SexALL

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Inclusion criteria

✓. 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.
✓. UACR between 200 and 3000 mg/g.
✓. Hemoglobin A1c ≤10% at Screening Visit.
✓. Subject who has been taking unchanged dosage of angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blockers (ARB) medication.
✓. Subject who has been on stable anti-hyperglycemic prior to screening.

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 DKD.
✕. History of renal transplant and/or plan to undergo a renal transplant during the study.
✕. History of acute kidney injury or renal dialysis.
✕. Subject with uncontrolled blood pressure.
✕. Subject taking immunosuppressant.
✕. Subject with known or suspected hypersensitivity to any components of the APX-115 formulation.
✕. Clinically significant abnormal laboratory findings at screening.

What they're measuring

Efficacy endpoint: Urine Albumin-Creatinine Ratio

Timeframe: Over 24 Weeks

Trial details

NCT IDNCT06962098

SponsorAptabio Therapeutics, Inc.

Sponsor typeINDIV

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Sung Jun Lim

+82-31-365-3693 cd@aptabio.com

View on ClinicalTrials.gov More Diabetic Kidney Disease (DKD) trials