Actively Recruiting
A Study to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy of AP1189 Versus Placebo for 12 Weeks as Add-On Treatment in Patients With Idiopathic Membranous Nephropathy and Severe Proteinuria
Led by SynAct Pharma Aps · Updated on 2026-03-06
23
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and efficacy of AP1189 in patients with idiopathic membranous nephropathy (iMN) who have severe proteinuria. This exploratory, randomized, double-blind, placebo-controlled study focuses on patients already receiving ACE inhibitor or angiotensin II receptor blocker treatment, aiming to understand how AP1189 affects these patients over a 12-week period. Participants will be randomly assigned in a 2:1 ratio to receive either 100 mg of AP1189 or a matching placebo daily for 12 weeks, alongside their ongoing treatments. The study is conducted at multiple centers and maintains a triple-blind design to ensure unbiased results. The AP1189 and placebo are administered as tablets taken once each day during the treatment period. During the study, participants will undergo regular monitoring including assessments of adverse events, blood tests for liver enzymes and bilirubin, and measurements of protein levels in urine over 24 hours. Researchers will also track albumin levels in urine. These evaluations occur up to week 12, covering safety and treatment effects. The study's total duration includes screening, 12 weeks of treatment, and follow-up to capture all relevant data on patient health and response to the investigational drug.
CONDITIONS
Brief 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
- Anti-PLA2-Receptor positive diagnosis within 6 months prior to inclusion
- Severe proteinuria defined by U-protein/creatinine ratio >3.0 g/g and/or U-albumin/creatinine ratio >2.0 g/g with plasma albumin below normal limit
- Estimated glomerular filtration rate (eGFR) above 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/discontinued 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 this study or within 4 weeks prior
- Clinical signs suggesting causes other than idiopathic membranous nephropathy for 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
- Use of systemic corticosteroids, immune suppressive or modulating drugs within 4 weeks before screening and during treatment
- Use of rituximab within 12 months before screening
- Active malignant disease
- Uncontrolled diseases like asthma, psoriasis, or inflammatory bowel disease treated with corticosteroids
- Serious uncontrolled cardiovascular, nervous system, 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 preventing compliance with study procedures
- Females of child-bearing potential in Sweden
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive either 100 mg AP1189 or placebo once daily as an add-on treatment to their ongoing medications for idiopathic membranous nephropathy and severe proteinuria.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
Aarhus Universitetshospital
Aarhus, Denmark, 8200
Actively Recruiting
Research Team
I
Irene Sandholdt
B
Birgitte Telmer, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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