Clinical Trial Details
| Trial ID: | L0393 |
| Source ID: | NCT01424319 |
| Associated Drug: | Atrasentan Low Dose Group |
| Title: | Reducing Residual Albuminuria in Subjects With Diabetes and Nephropathy With Atrasentan |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Kidney Disease|Diabetic Nephropathy |
| Interventions: | DRUG: Atrasentan low dose group|DRUG: Atrasentan high dose group|DRUG: Atrasentan placebo group |
| Outcome Measures: | Primary: The change from baseline to each post-baseline visit in log-transformed UACR (urinary albumin to creatinine ratio), Up to Week 12 | Secondary: The proportion of subjects who have achieved at least 30% reduction on UACR (Urinary Albumin to Creatinine Ratio) who have not had any form of treatment-emergent edema with moderate or severe severity., Up to Week 12|The change from baseline to each post-baseline visit on log-transformed UACR (Urinary Albumin to Creatinine Ratio) and estimated GFR (Glomerular Filtration Rate), Up to Week 12|The proportion of subjects who achieve various percent of reduction in UACR (Urinary Albumin to Creatinine Ratio) from baseline to final, Up to Week 12 |
| Sponsor/Collaborators: | Sponsor: AbbVie (prior sponsor, Abbott) |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 58 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2011-08 |
| Completion Date: | 2012-07 |
| Results First Posted: | |
| Last Update Posted: | 2017-08-29 |
| Locations: | Site Reference ID/Investigator# 62022, Azumino, Japan|Site Reference ID/Investigator# 58124, Chiba, Japan|Site Reference ID/Investigator# 57486, Fujisawa, Japan|Site Reference ID/Investigator# 55097, Ibaraki, Japan|Site Reference ID/Investigator# 56982, Ina, Japan|Site Reference ID/Investigator# 55093, Kawagoe, Japan|Site Reference ID/Investigator# 57485, Kawasaki, Japan|Site Reference ID/Investigator# 55092, Koriyama, Japan|Site Reference ID/Investigator# 56524, Matsumoto, Japan|Site Reference ID/Investigator# 57242, Nagano, Japan|Site Reference ID/Investigator# 60965, Nagoya-city, Japan|Site Reference ID/Investigator# 55781, Nagoya, Japan|Site Reference ID/Investigator# 55304, Suwa, Japan|Site Reference ID/Investigator# 59474, Tokyo, Japan|Site Reference ID/Investigator# 59967, Ueda, Japan|Site Reference ID/Investigator# 55095, Yokohama, Japan|Site Reference ID/Investigator# 57484, Yokohama, Japan|Site Reference ID/Investigator# 59842, Yokohama, Japan |
| URL: | https://clinicaltrials.gov/show/NCT01424319 |
