Clinical Trial Details
| Trial ID: | L3267 |
| Source ID: | NCT04534439 |
| Associated Drug: | Apx-115 |
| Title: | Safety, Tolerability and Renal Effects of APX-115 in Subjects With Type 2 Diabetes and Nephropathy |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetic Nephropathies|Diabetes Mellitus, Type 2|Nephropathy, Diabetic |
| Interventions: | DRUG: APX-115|DRUG: Placebo |
| Outcome Measures: | Primary: Mean change in urine albumin to creatinine ratio (UACR) in APX-115 group compared to placebo group, week 12 | |
| Sponsor/Collaborators: | Sponsor: Aptabio Therapeutics, Inc. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 140 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2020-08-24 |
| Completion Date: | 2021-08-23 |
| Results First Posted: | |
| Last Update Posted: | 2021-08-25 |
| Locations: | Pleven, Pleven, Bulgaria|Sveta Karidad, Plovdiv, Bulgaria|Diagnostic-consultative centre I, Sliven, Bulgaria|Hadzhi Dimitar, Sofia, Bulgaria|HERA, Sofia, Bulgaria|Medical center - Sveti Dimitar, Sofia, Bulgaria|Sirtuin, Sofia, Bulgaria|Sveta, Sofia, Bulgaria|Hristo Botev, Vratsa, Bulgaria|Sveti Panteleymon Yambol, Yambol, Bulgaria|Nefromed s.r.o, Praha, Czechia|Drug Research Center, Balatonfüred, Hungary|UNO MEDICAL Trials Kft., Budapest, Hungary|Mint House Private Medical Center, Székesfehérvár, Hungary|Bezanijska Kosa, Belgrade, Serbia|Clinical Centre of Serbia, clinic for endocrinology, diabetes and metabolism diseases, department for obesity, metabolic and reproductive disorders, Belgrade, Serbia |
| URL: | https://clinicaltrials.gov/show/NCT04534439 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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