Nephrotic Syndrome Due to Idiopathic Membranous NephropathyPhase 2NCT04456816
A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Patients With iMN and Severe Proteinuria
A Phase 2 study testing 100 mg AP1189 in people with Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy and Severe Proteinuria Due to Idiopathic Membranous Nephropathy, run by SynAct Pharma Aps at 1 site in Denmark.
Trial summary
This study is an exploratory, randomized, double-blind, multicenter, placebo-controlled study with repeated doses of AP1189. The study population will consist of patients with idiopathic membranous nephropathy (iMN) and severe proteinuria who are on ACE inhibitor or angiotensin II receptor blocker treatment. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy, Severe Proteinuria Due to Idiopathic Membranous Nephropathy
- What is being tested?
- 100 mg AP1189
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteDenmark
- Study dates
- 31 Aug 2020to 30 Jun 2026
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent has been obtained prior to initiating any study-specific procedures
- Male and female subjects, 18 to 85 years of age diagnosed with iMN within 6 months prior to inclusion
- Diagnosed as anti-PLA2-Receptor positive by local laboratory within 6 months prior to inclusion
- Severe proteinuria defined by a U-protein/creatinine ratio >3.0 g/g and/or U-albumin/creatinine ratio >2.0 g/g and a P-albumin below the lower normal limit
- eGFR > 30 ml/min/1.73m2
- Treated with ACE- inhibitors or angiotensin II receptor blocker for a minimum of 1 months with a stable systemic arterial blood pressure OR treatment with ACE inhibitors and/or angiotensin receptor blocker was excluded or discontinued due to hypotension, intolerance or other side effect
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- Only Denmark and Norway:
- Females of child-bearing potential using reliable means of contraception or are post-menopausal
- Females of childbearing potential with negative pregnancy test at screening and baseline
- Only Sweden:
- Post-menopausal women or women who are surgically sterilized.
Who cannot join
- Participation in any other study involving investigational drug(s) during the study and within 4 weeks prior to study entry
- Clinicial findings that in the opinion of the investigator would suggest condition(s) other than iMN as a major cause of severe proteinuria
- Major surgery within 8 weeks prior to screening or planned surgery within 1 month following randomization
- Blood pressure with systolic pressure above 160 mmHg and/or diastolic pressure above 100 mmHg despite antihypertensive treatment will in all cases be considered "uncontrolled"
- Treated with systemic corticosteroids, or other immune suppressive, or immune modulating compounds within 4 weeks prior to screening and during the entire treatment period and until the final visit
- Treated with rituximab within 12 months of screening
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- Evidence of active malignant disease
- Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
- Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disease
- Pregnant women or nursing mothers
- History of alcohol, drug, or chemical abuse within the 6 months prior to screening
- Any condition that in the view of the investigator would suggest that the patient is unable to comply with study protocol and procedures
- Only Sweden:
- Females of child-bearing potential.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus Universitetshospital
Aarhus, 8200
Henrik Birn, Professor, +45 40460271, henrbirn@rm.dk
About this study
Official title: An Exploratory, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AP1189 Versus Placebo Administered for 12 Weeks as an add-on to Patients, in ACE Inhibitor or Angiotensin II Receptor Blocker Treatment, With Idiopathic Membranous Nephropathy and Severe Proteinuria
This study is an exploratory, randomized, double-blind, multicenter, placebo-controlled study with repeated doses of AP1189. The study population will consist of patients with idiopathic membranous nephropathy (iMN) and severe proteinuria who are on ACE inhibitor or angiotensin II receptor blocker treatment.
Read the detailed description
This study is an exploratory, randomized, double-blind, multicenter, placebo-controlled study with repeated doses of AP1189. The study population will consist of patients with idiopathic membranous nephropathy (iMN) and severe proteinuria who are on ACE inhibitor or angiotensin II receptor blocker treatment.
Following a successful screening, subjects who fulfill the enrollment criteria will be randomized in a 2:1 ratio in group A and B:
- Group A (12 subjects): AP1189 dose 100 mg, once daily for 12 weeks (28 days) as an add-on to any ongoing treatment, including ACE inhibitors/ angiotensin II receptor blocker
- Group B (6 subjects): placebo for 12 weeks (28 days) as an add-on to any ongoing treatment including ACE inhibitors/ angiotensin II receptor blocker.
- Conditions
- Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy, Severe Proteinuria Due to Idiopathic Membranous Nephropathy
- Being tested
- 100 mg AP1189, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100 mg AP1189Drug
100 mg AP1189 tablet
PlaceboDrug
Matching placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| 100 mg AP1189 | Experimental | 100 mg AP1189. The treatment is a 12-weeks treatment. Each daily dose will be administered as a tablet Receives: Drug: 100 mg AP1189 |
| Placebo | Experimental | Placebo. The treatment is a 12-weeks treatment. Each daily dose will be administered as a tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
Evaluation of Adverse Event
Measured: Week 12
Serious Adverse Events
Evaluation of Serious Adverse Events
Measured: Week 12
ALAT change in plasma samples
Evaluation of ALAT compared with baseline
Measured: Week 12
ASAT change in plasma samples
Evaluation of ASAT compared with baseline
Measured: Week 12
Total bilirubin change in plasma samples
Evaluation of total bilirubin compared with baseline
Measured: Week 12
Alkaline phosphatase change in plasma samples
Evaluation of alkaline phosphatase compared with baseline
Measured: Week 12
Protein change in 24 hours urinary protein excretion
Change of protein in urine excretion compared to baseline measured in 24 h urinary protein excretion
Measured: Week 12
Secondary outcomes (1)
Albumin change in 24 hours urinary protein excretion
Change of albumin in urine excretion compared to baseline measured in 24 h urinary protein excretion
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 posted7 Jul 2020
- Study start31 Aug 2020
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic Syndrome Due to Idiopathic Membranous NephropathyStudies 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
- Model description
- Exploratory, randomized, double-blind, multi-center, placebo-controlled 12-weeks study with repeated doses of AP1189
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SynAct Pharma Aps
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henrik Birn, Professor, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456816
- Sponsor's protocol ID
- SynAct-CS003
- Status last verified
- Mar 2026
- First submitted
- 24 Jun 2020
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AP1189 Versus Placebo Administered for 12 Weeks as an add-on to Patients, in ACE Inhibitor or Angiotensin II Receptor Blocker Treatment, With Idiopathic Membranous Nephropathy and Severe Proteinuria
- ClinicalTrials.gov ID
- NCT04456816
- Acronym / sponsor ID
- SynAct-CS003
- Conditions
- Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy, Severe Proteinuria Due to Idiopathic Membranous Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- SynAct Pharma ApsIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 7 Jul 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 study is an exploratory, randomized, double-blind, multicenter, placebo-controlled study with repeated doses of AP1189. The study population will consist of patients with idiopathic membranous nephropathy (iMN) and severe proteinuria who are on ACE inhibitor or angiotensin II receptor blocker treatment.
Detailed description
This study is an exploratory, randomized, double-blind, multicenter, placebo-controlled study with repeated doses of AP1189. The study population will consist of patients with idiopathic membranous nephropathy (iMN) and severe proteinuria who are on ACE inhibitor or angiotensin II receptor blocker treatment.
Following a successful screening, subjects who fulfill the enrollment criteria will be randomized in a 2:1 ratio in group A and B:
- Group A (12 subjects): AP1189 dose 100 mg, once daily for 12 weeks (28 days) as an add-on to any ongoing treatment, including ACE inhibitors/ angiotensin II receptor blocker
- Group B (6 subjects): placebo for 12 weeks (28 days) as an add-on to any ongoing treatment including ACE inhibitors/ angiotensin II receptor blocker.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Exploratory, randomized, double-blind, multi-center, placebo-controlled 12-weeks study with repeated doses of AP1189
| Arm | Type | Receives |
|---|---|---|
| 100 mg AP1189 | Experimental | Drug: 100 mg AP1189100 mg AP1189. The treatment is a 12-weeks treatment. Each daily dose will be administered as a tablet |
| Placebo | Experimental | Drug: PlaceboPlacebo. The treatment is a 12-weeks treatment. Each daily dose will be administered as a tablet |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent has been obtained prior to initiating any study-specific procedures
- Male and female subjects, 18 to 85 years of age diagnosed with iMN within 6 months prior to inclusion
- Diagnosed as anti-PLA2-Receptor positive by local laboratory within 6 months prior to inclusion
- Severe proteinuria defined by a U-protein/creatinine ratio >3.0 g/g and/or U-albumin/creatinine ratio >2.0 g/g and a P-albumin below the lower normal limit
- eGFR > 30 ml/min/1.73m2
Key exclusion criteria (14 listed)
- Participation in any other study involving investigational drug(s) during the study and within 4 weeks prior to study entry
- Clinicial findings that in the opinion of the investigator would suggest condition(s) other than iMN as a major cause of severe proteinuria
- Major surgery within 8 weeks prior to screening or planned surgery within 1 month following randomization
- Blood pressure with systolic pressure above 160 mmHg and/or diastolic pressure above 100 mmHg despite antihypertensive treatment will in all cases be considered "uncontrolled"
- Treated with systemic corticosteroids, or other immune suppressive, or immune modulating compounds within 4 weeks prior to screening and during the entire treatment period and until the final visit
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 |
|---|---|---|
| 100 mg AP1189100 mg AP1189 tablet | Drug | 100 mg AP1189 |
| PlaceboMatching placebo tablet | Drug | Placebo |
Primary outcome
Adverse Event
Time frame: Week 12
Evaluation of Adverse Event
Serious Adverse Events
Time frame: Week 12
Evaluation of Serious Adverse Events
ALAT change in plasma samples
Time frame: Week 12
Evaluation of ALAT compared with baseline
ASAT change in plasma samples
Time frame: Week 12
Evaluation of ASAT compared with baseline
Total bilirubin change in plasma samples
Time frame: Week 12
Evaluation of total bilirubin compared with baseline
Alkaline phosphatase change in plasma samples
Time frame: Week 12
Evaluation of alkaline phosphatase compared with baseline
Protein change in 24 hours urinary protein excretion
Time frame: Week 12
Change of protein in urine excretion compared to baseline measured in 24 h urinary protein excretion
1 secondary outcome
Albumin change in 24 hours urinary protein excretion
Time frame: Week 12
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 6 Mar 2026.
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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.
Henrik Birn, Professor principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 100 mg AP1189 in people with Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy and Severe Proteinuria Due to Idiopathic Membranous Nephropathy, run by SynAct Pharma Aps at 1 site in Denmark.
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 11 inclusion and 14 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 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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. 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 Irene Sandholdt (+45 2015 7033, isa@croxxmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (time frame: Week 12). The study lists 7 primary outcomes in all. 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 6 Mar 2026.