Diabetic Kidney Disease (DKD)Phase 2PROMISS-DKDNCT06962098
Efficacy and Safety Study of Isuzinaxib in Subjects With DKD
A Phase 2 study testing Isuzinaxib in people with Diabetic Kidney Disease (DKD), run by Aptabio Therapeutics, Inc. at 20 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetic Kidney Disease (DKD)
- What is being tested?
- Isuzinaxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 20 sitesSouth Korea
- Study dates
- 26 May 2025to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
South Korea20 sites, 20 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan-si
Jin-Joo Cha
- Not yet recruiting
Inje university Busan Paik Hospital
Busan
Taehee Kim
- Recruiting
Pusan National University Hospital
Busan
Sang Heon Song
- Recruiting
SoonChunHyang University Hospital Cheonan
Cheonan
EunYoung Lee
- Recruiting
Keimyung University Daegu Dongsan Hospital
Daegu
Seung-Yeup Han
- Recruiting
Inje university Ilsan Paik Hospital
Goyang-si
Sang Youb Han
- Recruiting
Hanyang University Guri Hospital
Guri-si
Sang-Woong Han
- Recruiting
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong
Su-Hyun Kim
- Recruiting
The Catholic University of Korea Incheon St. Mary's Hospital
Incheon
Seok Joon Shin
- Not yet recruiting
Jeonbuk National University Hospital
Jeonju
Won Kim
- Recruiting
CHA Bundang Medical Center
Seongnam-si
So-Young Lee
- Recruiting
Boramae Medical Center
Seoul
Jung-Pyo Lee
- Recruiting
Korea University Guro Hospital
Seoul
Gang-jee Ko
- Recruiting
Kyung Hee University Hospital at Gangdon
Seoul
Ju-Young Moon
- Recruiting
Seoul National University Hospital
Seoul
Seung Seok Han
- Recruiting
Severance Hospital
Seoul
Tae-Hyun Yoo
- Recruiting
The Catholic University of Korea Seoul ST.MARY'S Hospital
Seoul
Yaeni Kim
- Recruiting
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Uijeongbu-si
Sun-Ae Yoon
- Not yet recruiting
Wonju Severance Christian Hospital
Wŏnju
Byoung Geun Han
- Recruiting
Pusan National University Yangsan Hospital
Yangsan
Seo Rin Kim
About this study
Official title: A Phase 2b Randomized, Double-blind, Placebo-controlled, Dose-ranging, Multicenter Study to Evaluate the Efficacy and Safety of Isuzinaxib in Subjects With Diabetic Kidney Disease
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.
- Conditions
- Diabetic Kidney Disease (DKD)
- Being tested
- Isuzinaxib, Placebo
- Keywords
- Isuzinaxib, APX-115, NOX, Diabetic Nephropathy, DN, Diabetic Kidney Disease, DKD
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsuzinaxibDrug
Also called APX-115
Oral dosing regimen once daily
PlaceboDrug
Oral dosing regimen once daily
| Study group | Role | What they receive |
|---|---|---|
| Isuzinaxib 400 mg | Active comparator | Subject will receive the 400 mg of Isuzinaxib. Receives: Drug: Isuzinaxib |
| Isuzinaxib 200 mg | Active comparator | Subject will receive the 200 mg of Isuzinaxib. Receives: Drug: Isuzinaxib |
| Placebo | Placebo comparator | Subject will receive the Placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy endpoint: Urine Albumin-Creatinine Ratio
Change in Urine Albumin-Creatinine Ratio from baseline through Week 24 in the Isuzinaxib treatment groups versus the placebo group
Measured: Over 24 Weeks
Secondary outcomes (6)
Efficacy endpoint: eGFR
Change from baseline in the eGFR
Measured: Over 24 Weeks
Efficacy endpoint: Urine Albumin-Creatinine Ratio
Change in Urine Albumin-Creatinine Ratio from baseline through Week 20 in the Isuzinaxib treatment groups versus the placebo group
Measured: Over 20 Weeks
Efficacy endpoint: Urine Albumin-Creatinine Ratio decrease
Subjects with a percentage decrease in Urine Albumin-Creatinine Ratio
Measured: Over 24 Weeks
Efficacy endpoint: Incidence of Composite Renal Outcome
Number of subjects with end-stage kidney disease, kidney-related death, or renal replacement therapy
Measured: Over 24 Weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of treatment-emergent adverse events
Measured: Over 24 Weeks
PK Endpoint: Pharmacokinetics
Assessment of plasma concentrations of Isuzinaxib
Measured: Over 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start26 May 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney Disease (DKD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aptabio Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962098
- Sponsor's protocol ID
- APX-115-05
- Acronym
- PROMISS-DKD
- Status last verified
- Jul 2025
- First submitted
- 16 Apr 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Randomized, Double-blind, Placebo-controlled, Dose-ranging, Multicenter Study to Evaluate the Efficacy and Safety of Isuzinaxib in Subjects With Diabetic Kidney Disease
- ClinicalTrials.gov ID
- NCT06962098
- Acronym / sponsor ID
- PROMISS-DKD / APX-115-05
- Conditions
- Diabetic Kidney Disease (DKD)
- Keywords
- Isuzinaxib, APX-115, NOX, Diabetic Nephropathy, DN, Diabetic Kidney Disease, DKD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Aptabio Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 May 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Isuzinaxib 400 mg | Active comparator | Drug: IsuzinaxibSubject will receive the 400 mg of Isuzinaxib. |
| Isuzinaxib 200 mg | Active comparator | Drug: IsuzinaxibSubject will receive the 200 mg of Isuzinaxib. |
| Placebo | Placebo comparator | Drug: PlaceboSubject will receive the Placebo. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsuzinaxibAlso: APX-115Oral dosing regimen once daily | Drug | Isuzinaxib 200 mg, Isuzinaxib 400 mg |
| PlaceboOral dosing regimen once daily | Drug | Placebo |
Primary outcome
Efficacy endpoint: Urine Albumin-Creatinine Ratio
Time frame: Over 24 Weeks
Change in Urine Albumin-Creatinine Ratio from baseline through Week 24 in the Isuzinaxib treatment groups versus the placebo group
6 secondary outcomes
Efficacy endpoint: eGFR
Time frame: Over 24 Weeks
Efficacy endpoint: Urine Albumin-Creatinine Ratio
Time frame: Over 20 Weeks
Efficacy endpoint: Urine Albumin-Creatinine Ratio decrease
Time frame: Over 24 Weeks
Efficacy endpoint: Incidence of Composite Renal Outcome
Time frame: Over 24 Weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Over 24 Weeks
PK Endpoint: Pharmacokinetics
Time frame: Over 24 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isuzinaxib in people with Diabetic Kidney Disease (DKD), run by Aptabio Therapeutics, Inc. at 20 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sung Jun Lim (+82-31-365-3693, cd@aptabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy endpoint: Urine Albumin-Creatinine Ratio (time frame: Over 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.