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Tests treatment safety and results for Diabetic Kidney Disease (DKD)
Official title Efficacy and Safety Study of Isuzinaxib in Subjects With DKD
ClinicalTrials.gov ID: NCT06962098
What this study is testing
What is Isuzinaxib?
Isuzinaxib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for diabetic kidney disease (dkd).
Also referred to as APX-115.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- Females of childbearing potential/sexually active males with a partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control.
- Willing to be under dietary management for diabetes.
- Willing to comply with all study procedures and availability for the duration of the study.
- Capable of understanding the content of and able voluntarily to provide a signed and dated written informed consent form (ICF) prior to any study procedures.
- 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.
- History of drug or alcohol abuse within 1 year prior to screening.
- History of any cardiovascular event or cardiovascular procedure planned during the clinical study.
- Current or history of New York Heart Association class III or IV heart failure.
- Clinically significant electrocardiogram (ECG) abnormalities.
- Known significant liver disease.
- Subject with active urinary tract infection or has not fully recovered before randomization.
- History of malignancy within 5 years prior to screening.
- Administration of any investigational product.
- Major surgery within 28 days or not fully recovered surgery prior to randomization or major surgery planned during the next 6 months.
- Positive hepatitis B surface antigen.
- Female subject who is pregnant or breastfeeding.
- Other medical history which in the opinion of the Investigator would make the subject unsuitable for participation in the study.
- Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study or unable to cooperate because of a language problem or poor mental status.
The study team makes the final eligibility decision.
Where it's taking place
- Ansan-si, South Korea
- Busan, South Korea
- Cheonan, South Korea
- Daegu, South Korea
- Goyang-si, South Korea
- Guri-si, South Korea
- Gwangmyeong, South Korea
- Incheon, South Korea
- Jeonju, South Korea
- Seongnam-si, South Korea
- Seoul, South Korea
- Uijeongbu-si, South Korea
- Wŏnju, South Korea
- Yangsan, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ansan-si, South Korea; Busan, South Korea; Cheonan, South Korea; Daegu, South Korea; Goyang-si, South Korea; Guri-si, South Korea and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.