Efficacy and Safety Study of Isuzinaxib in Subjects With DKD
Recruiting
Phase 2
Interventional Study
Diabetic Kidney Disease (DKD)
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 19 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 186 (estimated)
- Sponsor
- Aptabio Therapeutics, Inc. · Industry
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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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male/female subject aged ≥19 years inclusive at the time of informed consent.
2. Clinical diagnosis of type 2 diabetes and DKD.
3. 18.5 kg/m² \< body mass index \< 35 kg/m².
4. Stable UACR values prior to screening visit.
5. UACR between 200 and 3000 mg/g.
6. Hemoglobin A1c ≤…
Contacts