A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Patients With iMN and Severe Proteinuria
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ClinicalTrials.gov Identifier: NCT04456816 |
Recruitment Status :
Recruiting
First Posted : July 7, 2020
Last Update Posted : November 17, 2022
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Condition or disease | Intervention/treatment | Phase |
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Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy Severe Proteinuria Due to Idiopathic Membranous Nephropathy | Drug: 100 mg AP1189 Drug: Placebo | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 23 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Exploratory, randomized, double-blind, multi-center, placebo-controlled 12-weeks study with repeated doses of AP1189 |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | August 31, 2020 |
Estimated Primary Completion Date : | December 31, 2023 |
Estimated Study Completion Date : | December 31, 2023 |

Arm | Intervention/treatment |
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Experimental: 100 mg AP1189
100 mg AP1189. The treatment is a 12-weeks treatment. Each daily dose will be administered as a tablet
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Drug: 100 mg AP1189
100 mg AP1189 tablet |
Experimental: Placebo
Placebo. The treatment is a 12-weeks treatment. Each daily dose will be administered as a tablet
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Drug: Placebo
Matching placebo tablet |
- 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
- Albumin change in 24 hours urinary protein excretion [ Time Frame: Week 12 ]Change of albumin in urine excretion compared to baseline measured in 24 h urinary protein excretion

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
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.
Exclusion Criteria:
- 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
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456816
Contact: Irene Sandholdt | +45 2015 7033 | isa@croxxmed.com | |
Contact: Birgitte Telmer, MD | +45 2015 1221 | bte@croxxmed.com |
Denmark | |
Aarhus Universitetshospital | Recruiting |
Aarhus, Denmark, 8200 | |
Contact: Henrik Birn, Professor +45 40460271 henrbirn@rm.dk |
Principal Investigator: | Henrik Birn, Professor | Aarhus Universitetshospital |
Responsible Party: | SynAct Pharma Aps |
ClinicalTrials.gov Identifier: | NCT04456816 |
Other Study ID Numbers: |
SynAct-CS003 |
First Posted: | July 7, 2020 Key Record Dates |
Last Update Posted: | November 17, 2022 |
Last Verified: | November 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Kidney Diseases Proteinuria Nephrotic Syndrome Nephrosis Glomerulonephritis, Membranous Urologic Diseases |
Urination Disorders Urological Manifestations Glomerulonephritis Nephritis Autoimmune Diseases Immune System Diseases |