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 groupsSponsors and collaborators
Source ClinicalTrials.gov