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
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
Treatments tested in this trial
- Isuzinaxib
- Placebo
Treatment groups
186 Participants
are divided into 3 treatment groupsLocations
20Korea University Ansan Hospital Ansan-si South Korea
Inje university Busan Paik Hospital Busan South Korea
Pusan National University Hospital Busan South Korea
SoonChunHyang University Hospital Cheonan Cheonan South Korea
Sponsors and collaborators
Aptabio Therapeutics, Inc.
Lead sponsor
Source ClinicalTrials.gov