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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005710-11 | EudraCT Number |
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Primary objective:
- To characterize the effects of 12 weeks treatment with study drug on albumin-creatinine ratio (ACR) in patients with type 2 diabetes and albuminuria
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOX-E36 | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOX-E36 | Drug | 0.5 mg/kg study drug or placebo as SC injections twice a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of NOX-E36 on albuminuria as measured by ACR (albumin to creatinine ratio; mg/g) | ACR calculated in first morning void urine; comparison of patients treated with NOX-E36 versus placebo | Change versus baseline after 12 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of NOX-E36 on hsCRP | Comparison of patients treated with NOX-E36 versus placebo | Change versus baseline after 12 weeks treatment |
| Effect of NOX-E36 on HbA1C | Comparison of patients treated with NOX-E36 versus placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kai Riecke, MD | Noxxon AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prague | Czechia | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30957581 | Derived | Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19. |
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| Change versus baseline after 12 weeks treatment |
| Effect of NOX-E36 on HOMA-IR | Comparison of patients treated with NOX-E36 versus placebo | Change versus baseline after 12 weeks treatment |
| Effect of NOX-E36 on eGFR | eGFR will be calculated by the CKD-EPI equation using creatinine and cystatin C Comparison of patients treated with NOX-E36 versus placebo | Change versus baseline after 12 weeks treatment |
| Aschaffenburg |
| Germany |
| Dortmund | Germany |
| Düsseldorf | Germany |
| Hanover | Germany |
| Kronberg | Germany |
| Mainz | Germany |
| Mannheim | Germany |
| Offenbach | Germany |
| Schwabenheim | Germany |
| Witten | Germany |
| Balatonfüred | Hungary |
| Budapest | Hungary |
| Gyula | Hungary |
| Miskolc | Hungary |
| Pécs | Hungary |
| Szeged | Hungary |
| Bialystok | Poland |
| Grodzisk Mazowiecki | Poland |
| Katowice | Poland |
| Warsaw | Poland |
| Arad | Romania |
| Bucharest | Romania |
| Timișoara | Romania |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D000419 | Albuminuria |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D011507 | Proteinuria |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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