A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Pa… (NCT04456816) | Clinical Trial Compass
RecruitingPhase 2
A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Patients With iMN and Severe Proteinuria
Denmark23 participantsStarted 2020-08-31
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pres…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse Event
Timeframe: Week 12
2
Serious Adverse Events
Timeframe: Week 12
3
ALAT change in plasma samples
Timeframe: Week 12
4
ASAT change in plasma samples
Timeframe: Week 12
5
Total bilirubin change in plasma samples
Timeframe: Week 12
6
Alkaline phosphatase change in plasma samples
Timeframe: Week 12
7
Protein change in 24 hours urinary protein excretion