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An exploratory, randomized, double-blind, multicenter, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and efficacy of AP1189 daily doses versus placebo administered for 12 weeks as an addon to patients, in ACE inhibitor or angiotensin II receptor blocker treatment, with idiopathic membranous nephropathy and severe proteinuria
EU CTIS ID: 2024-518384-36-00
What this study is testing
To compare the safety of AP1189 against placebo by evaluating adverse events (AEs), serious adverse events (SAEs), vital signs, electrocardiograms and laboratory abnormalities. The result of 12 weeks of treatment on 24 hours urinary protein excretion as expressed as changes in urine excretion from baseline to the end of the twelve weeks treatment period (baseline is defined as 24 h urinary protein excretion determined prior to dosing with AP1189 or placebo).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent has been obtained prior to initiating any study-specific procedures
- Male and female subjects, 18 to 85 years of age with iMN and severe proteinuria
- Diagnosed as anti-PLA2-Receptor positive by local laboratory within 6 months prior to inclusion and/or having a renal biopsy consistent with iMN within 24 months of 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 P-albumin below the lower normal limit
- eGFR > 30 ml/min/1.73m2
- Treatment with ACE- inhibitors or angiotensin II receptor blocker for a minimum of 1 month 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 effects
You likely can't join if
- Participation in any other study involving investigational drug(s) during the study and within 4 weeks prior to study entry
- Pregnant women or nursing (breastfeeding) 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 (e.g., psychiatric disorders, dementia)
- ONLY SWEDEN: Females of child-bearing potential
- Clinical findings that in the opinion of the investigator would suggest condition(s) other than iMN as a major cause of severe proteinuria
See the full eligibility criteria
- Written informed consent has been obtained prior to initiating any study-specific procedures
- Male and female subjects, 18 to 85 years of age with iMN and severe proteinuria
- Diagnosed as anti-PLA2-Receptor positive by local laboratory within 6 months prior to inclusion and/or having a renal biopsy consistent with iMN within 24 months of 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 P-albumin below the lower normal limit
- eGFR > 30 ml/min/1.73m2
- Treatment with ACE- inhibitors or angiotensin II receptor blocker for a minimum of 1 month 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 effects
- ONLY DENNMARK AND NORWAY: Females of child-bearing potential using reliable means of contraception (for detailed information see section 17.8) or are postmenopausal (menstrual periods stopped at least 12 months ahead of the enrolment in the trial) or are surgically sterilized (the procedure must have been performed at least 6 months prior to screening)
- ONLY DENNMARK AND NORWAY: Females of childbearing potential with negative pregnancy test at screening and baseline
- ONLY SWEDEN: Post-menopausal women (menstrual periods stopped at least 12 months ahead of the enrolment in the trial) or women who are surgically sterilized (the procedure must have been performed at least 6 months prior to screening)
- Participation in any other study involving investigational drug(s) during the study and within 4 weeks prior to study entry
- Pregnant women or nursing (breastfeeding) 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 (e.g., psychiatric disorders, dementia)
- ONLY SWEDEN: Females of child-bearing potential
- Clinical 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 one 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 (oral, intramuscular or IV) corticosteroids, or other immune suppressive, or immune modulating compounds within 4 weeks (8 weeks for IV cyclophosphamide) 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 (except basal cell carcinoma of the skin that has been excised and cured).
- 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 (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), or gastrointestinal disease
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.