Trials / Recruiting
RecruitingNCT04456816
A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Patients With iMN and Severe Proteinuria
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 23 (estimated)
- Sponsor
- SynAct Pharma Aps · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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. Following a successful screening, subjects who fulfill the enrollment criteria will be randomized in a 2:1 ratio in group A and B: * Group A (12 subjects): AP1189 dose 100 mg, once daily for 12 weeks (28 days) as an add-on to any ongoing treatment, including ACE inhibitors/ angiotensin II receptor blocker * Group B (6 subjects): placebo for 12 weeks (28 days) as an add-on to any ongoing treatment including ACE inhibitors/ angiotensin II receptor blocker.
Conditions
- Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy
- Severe Proteinuria Due to Idiopathic Membranous Nephropathy
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 100 mg AP1189 | 100 mg AP1189 tablet |
| DRUG | Placebo | Matching placebo tablet |
Timeline
- Start date
- 2020-08-31
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
- First posted
- 2020-07-07
- Last updated
- 2026-03-06
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04456816. Inclusion in this directory is not an endorsement.