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Clinical Trial Details

Trial ID: L0397
Source ID: NCT01399580
Associated Drug: Atrasentan
Title: A Prospective, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of Atrasentan, Including Thoracic Bioimpedance, in Type 2 Diabetic Subjects With Nephropathy
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|Diabetic Nephropathy
Interventions: DRUG: Atrasentan|DRUG: Placebo
Outcome Measures: Primary: Change from baseline to each post-baseline visit up to Week 8 in log-transformed Urinary Albumin to Creatinine Ratio (UACR), Every two weeks for 8 weeks | Secondary: Change from baseline to each post baseline measure for estimated glomerular filtration rate (eGFR), Every two weeks for 8 weeks|The change from baseline to each post-baseline assessment of thoracic bioimpedance, Treatment Day 1, Week 1, 2, 4, 6, 8 and 30 days post-treatment
Sponsor/Collaborators: Sponsor: AbbVie (prior sponsor, Abbott)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 48
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: 2012-09
Results First Posted:
Last Update Posted: 2013-10-25
Locations: Site Reference ID/Investigator# 58144, Phoenix, Arizona, 85032, United States|Site Reference ID/Investigator# 71034, Tempe, Arizona, 85284, United States|Site Reference ID/Investigator# 56927, Azusa, California, 91702, United States|Site Reference ID/Investigator# 70793, Azusa, California, 91702, United States|Site Reference ID/Investigator# 64027, Chula Vista, California, 91910, United States|Site Reference ID/Investigator# 54120, Concord, California, 94520, United States|Site Reference ID/Investigator# 64026, La Mesa, California, 91942, United States|Site Reference ID/Investigator# 70173, Los Angeles, California, 90048, United States|Site Reference ID/Investigator# 54121, Denver, Colorado, 80209, United States|Site Reference ID/Investigator# 56924, Boynton Beach, Florida, 33472, United States|Site Reference ID/Investigator# 56642, Hollywood, Florida, 33021, United States|Site Reference ID/Investigator# 68986, Augusta, Georgia, 30901, United States|Site Reference ID/Investigator# 56644, Chicago, Illinois, 60611, United States|Site Reference ID/Investigator# 54129, Baton Rouge, Louisiana, 70808, United States|Site Reference ID/Investigator# 68982, Pontiac, Michigan, 48341, United States|Site Reference ID/Investigator# 64023, Albany, New York, 12206, United States|Site Reference ID/Investigator# 55543, Flushing, New York, 11355, United States|Site Reference ID/Investigator# 54164, Fargo, North Dakota, 58103, United States|Site Reference ID/Investigator# 58147, Willoughby Hills, Ohio, 44094, United States|Site Reference ID/Investigator# 54123, Bethlehem, Pennsylvania, 18017, United States|Site Reference ID/Investigator# 61742, Pittsburg, Pennsylvania, 15224, United States|Site Reference ID/Investigator# 54132, Chattanooga, Tennessee, 37408, United States|Site Reference ID/Investigator# 54108, Dallas, Texas, 75231, United States|Site Reference ID/Investigator# 54126, Greenville, Texas, 75402, United States|Site Reference ID/Investigator# 58153, Houston, Texas, 77024, United States|Site Reference ID/Investigator# 54110, Houston, Texas, 77099, United States|Site Reference ID/Investigator# 54116, North Richland Hills, Texas, 76180, United States|Site Reference ID/Investigator# 54173, Silverdale, Washington, 98383, United States
URL: https://clinicaltrials.gov/show/NCT01399580

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D440 Atrasentan small molecule DB06199 Details