Actively Recruiting
A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Patients With iMN and Severe Proteinuria
Led by SynAct Pharma Aps · Updated on 2026-03-06
23
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Patients With iMN and Severe Proteinuria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained before any study procedures
- Male or female aged 18 to 85 years diagnosed with idiopathic membranous nephropathy within 6 months prior to inclusion
- Positive for anti-PLA2-Receptor within 6 months prior to inclusion
- Severe proteinuria defined by urine protein/creatinine ratio >3.0 g/g and/or urine albumin/creatinine ratio >2.0 g/g with low plasma albumin
- eGFR greater than 30 ml/min/1.73m2
- Treated with ACE inhibitors or angiotensin II receptor blockers for at least 1 month with stable blood pressure, or treatment excluded or stopped due to intolerance
- For females of child-bearing potential in Denmark and Norway: using reliable contraception or post-menopausal
- For females of childbearing potential in Denmark and Norway: negative pregnancy test at screening and baseline
- For females in Sweden: post-menopausal or surgically sterilized
You will not qualify if you...
- Participation in another investigational drug study during or within 4 weeks prior to this study
- Clinical signs suggesting conditions other than idiopathic membranous nephropathy causing severe proteinuria
- Major surgery within 8 weeks before screening or planned surgery within 1 month after randomization
- Uncontrolled blood pressure above 160/100 mmHg despite treatment
- Treatment with systemic corticosteroids, immune suppressive, or immune modulating drugs within 4 weeks prior to screening and during study
- Rituximab treatment within 12 months before screening
- Active malignant disease
- Uncontrolled diseases like asthma, psoriasis, or inflammatory bowel disease treated with steroids
- Serious uncontrolled cardiovascular, nervous, pulmonary, renal, hepatic, endocrine, or gastrointestinal diseases
- Pregnant or nursing women
- History of alcohol, drug, or chemical abuse within 6 months before screening
- Any condition suggesting inability to comply with study procedures
- For females of child-bearing potential in Sweden
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Aarhus Universitetshospital
Aarhus, Denmark, 8200
Actively Recruiting
Research Team
I
Irene Sandholdt
CONTACT
B
Birgitte Telmer, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here