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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 mg AP1189 | Experimental | 100 mg AP1189. The treatment is a 12-weeks treatment. Each daily dose will be administered as a tablet |
|
| Placebo | Experimental | Placebo. The treatment is a 12-weeks treatment. Each daily dose will be administered as a tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 100 mg AP1189 | Drug | 100 mg AP1189 tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | Evaluation of Adverse Event | Week 12 |
| Serious Adverse Events | Evaluation of Serious Adverse Events | Week 12 |
| ALAT change in plasma samples | Evaluation of ALAT compared with baseline | Week 12 |
| ASAT change in plasma samples | Evaluation of ASAT compared with baseline | Week 12 |
| Total bilirubin change in plasma samples | Evaluation of total bilirubin compared with baseline | Week 12 |
| Alkaline phosphatase change in plasma samples | Evaluation of alkaline phosphatase compared with baseline | Week 12 |
| Protein change in 24 hours urinary protein excretion | Change of protein in urine excretion compared to baseline measured in 24 h urinary protein excretion | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Albumin change in 24 hours urinary protein excretion | Change of albumin in urine excretion compared to baseline measured in 24 h urinary protein excretion | Week 12 |
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Inclusion Criteria:
Only Denmark and Norway:
Only Sweden:
Exclusion Criteria:
Only Sweden:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irene Sandholdt | Contact | +45 2015 7033 | isa@croxxmed.com | |
| Birgitte Telmer, MD | Contact | +45 2015 1221 | bte@croxxmed.com |
| Name | Affiliation | Role |
|---|---|---|
| Henrik Birn, Professor | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus Universitetshospital | Recruiting | Aarhus | 8200 | Denmark |
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Exploratory, randomized, double-blind, multi-center, placebo-controlled 12-weeks study with repeated doses of AP1189
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| Drug |
Matching placebo tablet |
|
| ID | Term |
|---|---|
| C000598194 | N-(3-(1-(2-nitrophenyl)-1H-pyrrol-2-yl)allylidenamino)guanidine |
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