Diabetic NephropathiesPhase 2NCT04534439
Safety, Tolerability and Renal Effects of APX-115 in Subjects With Type 2 Diabetes and Nephropathy
A Phase 2 study testing APX-115 in people with Diabetic Nephropathies and Diabetes Mellitus, Type 2, run by Aptabio Therapeutics, Inc. at 16 sites in 4 countries.
Trial summary
This is a proof of concept (PoC) trial to evaluate the safety, tolerability and renal effect of APX-115 in subjects with Type 2 diabetes and nephropathy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Nephropathies, Diabetes Mellitus, Type 2, Nephropathy, Diabetic
- What is being tested?
- APX-115
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 16 sitesin 4 countries
- Study dates
- 24 Aug 2020to 23 Aug 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Diagnosis of type 2 diabetes and nephropathy
- First morning void (FMV) UACR between 200 and 3000 mg/g, inclusive
- 30 mL/min/1.73m2 ≤ eGFR ≤ 90 mL/min/1.73m2 using CKD-EPI formula at screening
- HbA1c ≤ 10% at screening visit
- Subject who has been taking unchanged dosage of ACE inhibitor or ARB medication for at least 3 months prior to screening and is not anticipated to change its dosage during the course of the study
- Willing to be under dietary management for diabetes
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 Diabetic Kidney Disease
- Subject with uncontrolled blood pressure
- Clinically significant abnormal laboratory findings
- History of any cardiovascular event within 6 months prior to screening or cardiovascular procedure planned during the clinical trial
- Diagnostic or interventional procedure requiring a contrast agent within 4 weeks before the screening visit or planned during the course of the study
- Clinically significant ECG abnormalities on a 12-lead ECG at the screening visit or before randomization
- Current or history of NYHA class IV heart failure
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
Bulgaria10 sites
Pleven
Pleven
Sveta Karidad
Plovdiv
Diagnostic-consultative centre I
Sliven
Hadzhi Dimitar
Sofia
HERA
Sofia
Medical center - Sveti Dimitar
Sofia
Sirtuin
Sofia
Sveta
Sofia
Hristo Botev
Vratsa
Sveti Panteleymon Yambol
Yambol
Hungary3 sites
Drug Research Center
Balatonfüred
UNO MEDICAL Trials Kft.
Budapest
Mint House Private Medical Center
Székesfehérvár
Serbia2 sites
Bezanijska Kosa
Belgrade
Clinical Centre of Serbia, clinic for endocrinology, diabetes and metabolism diseases, department for obesity, metabolic and reproductive disorders
Belgrade
About this study
Official title: A Randomized, Placebo-controlled, Double-blinded, Multi-centre, Phase 2 Study to Assess Safety, Tolerability and Renal Effects of APX-115 in Subjects With Type 2 Diabetes and Nephropathy
This is a proof of concept (PoC) trial to evaluate the safety, tolerability and renal effect of APX-115 in subjects with Type 2 diabetes and nephropathy.
- Being tested
- APX-115, Placebo
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APX-115Drug
oral administration of APX-115 400mg capsule once daily for 12 weeks
PlaceboDrug
oral administration of APX-115-matching placebo 400mg capsule once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| APX-115 | Experimental | Oral administration of APX-115 400mg, daily Receives: Drug: APX-115 |
| Placebo | Placebo comparator | Oral administration of APX-115-matching placebo 400mg, daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in urine albumin to creatinine ratio (UACR) in APX-115 group compared to placebo group
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start24 Aug 2020
- Primary completion26 Jul 2021
- Study completion23 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathiesStudies 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aptabio Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Istavan Wittmann, MD, Principal investigator, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534439
- Sponsor's protocol ID
- A01-115-02-EU
- Other IDs
- 2019-004155-37, 2019
- Status last verified
- Aug 2021
- First submitted
- 27 Aug 2020
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jang J, Yu H, Oh EB, Park JW, Kim S, Kim T, Sohn J, Jin BR, Chang TS. Targeting NADPH Oxidase with APX-115: Suppression of Platelet Activation and Thrombotic Response. Antioxid Redox Signal. 2025 Aug;43(4-6):288-307. doi: 10.1089/ars.2024.0695. Epub 2025 Apr 4.
PubMed 40183134
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blinded, Multi-centre, Phase 2 Study to Assess Safety, Tolerability and Renal Effects of APX-115 in Subjects With Type 2 Diabetes and Nephropathy
- ClinicalTrials.gov ID
- NCT04534439
- Acronym / sponsor ID
- A01-115-02-EU
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Aptabio Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 23 Aug 2021 (actual)
- First posted
- 1 Sep 2020 (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 is a proof of concept (PoC) trial to evaluate the safety, tolerability and renal effect of APX-115 in subjects with Type 2 diabetes and nephropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APX-115 | Experimental | Drug: APX-115Oral administration of APX-115 400mg, daily |
| Placebo | Placebo comparator | Drug: PlaceboOral administration of APX-115-matching placebo 400mg, daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical Diagnosis of type 2 diabetes and nephropathy
- First morning void (FMV) UACR between 200 and 3000 mg/g, inclusive
- 30 mL/min/1.73m2 ≤ eGFR ≤ 90 mL/min/1.73m2 using CKD-EPI formula at screening
- HbA1c ≤ 10% at screening visit
- Subject who has been taking unchanged dosage of ACE inhibitor or ARB medication for at least 3 months prior to screening and is not anticipated to change its dosage during the course of the study
Key exclusion criteria (8 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 Diabetic Kidney Disease
- Subject with uncontrolled blood pressure
- Clinically significant abnormal laboratory findings
- History of any cardiovascular event within 6 months prior to screening or cardiovascular procedure planned during the clinical trial
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 |
|---|---|---|
| APX-115oral administration of APX-115 400mg capsule once daily for 12 weeks | Drug | APX-115 |
| Placebooral administration of APX-115-matching placebo 400mg capsule once daily for 12 weeks | Drug | Placebo |
Primary outcome
Mean change in urine albumin to creatinine ratio (UACR) in APX-115 group compared to placebo group
Time frame: week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Derived from this study: PubMed 40183134Jang J, Yu H, Oh EB, Park JW, Kim S, Kim T, Sohn J, Jin BR, Chang TS. Targeting NADPH Oxidase with APX-115: Suppression of Platelet Activation and Thrombotic Response. Antioxid Redox Signal. 2025 Aug;43(4-6):288-307. doi: 10.1089/ars.2024.0695. Epub 2025 Apr 4.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Istavan Wittmann, MD principal investigator
University of Pecs
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing APX-115 in people with Diabetic Nephropathies and Diabetes Mellitus, Type 2, run by Aptabio Therapeutics, Inc. at 16 sites in 4 countries.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Bulgaria, Hungary, Serbia, Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in urine albumin to creatinine ratio (UACR) in APX-115 group compared to placebo group (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04534439, which also lists 1 linked publication.
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 25 Aug 2021.