Treatment with AP1189 for patients with severe proteinuria due to idiopathic membranous nephropathy
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
This study is testing if a new drug called AP1189 can help people with severe proteinuria caused by idiopathic membranous nephropathy feel better when added to their current treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 23 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | SynAct Pharma Aps Industry-sponsored |
| Drugs / interventions | rituximab |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT04456816 on ClinicalTrials.gov |
What this trial studies
This is an exploratory, randomized, double-blind, multicenter, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and efficacy of AP1189 in patients diagnosed with idiopathic membranous nephropathy (iMN) and severe proteinuria. Participants will be randomized into two groups, with one receiving AP1189 and the other a placebo, both as an add-on to their ongoing treatment with ACE inhibitors or angiotensin II receptor blockers. The study aims to assess the impact of AP1189 over a 12-week period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 diagnosed with iMN and severe proteinuria who are currently on ACE inhibitors or angiotensin II receptor blockers.
Not a fit: Patients who do not have idiopathic membranous nephropathy or those with eGFR below 30 ml/min/1.73m2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce proteinuria and improve kidney function in patients with iMN.
How similar studies have performed: Other studies have explored treatments for idiopathic membranous nephropathy, but the specific approach of using AP1189 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aarhus
- Aarhus Universitetshospital — Aarhus, Denmark (Recruiting)
Study contacts
- Principal investigator: Henrik Birn, Professor — Aarhus University Hospital
- Study coordinator: Irene Sandholdt
- Email: isa@croxxmed.com
- Phone: +45 2015 7033
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.