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Clinical Trial Details

Trial ID: L0406
Source ID: NCT00920764
Associated Drug: Placebo For Atrasentan 0.2 Mg/Ml Solution
Title: A Study of Atrasentan on Reducing Albuminuria in Type 2 Diabetic Nephropathy Treated With Renin-Angiotensin System Inhibitors
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|Diabetic Nephropathy
Interventions: DRUG: Placebo for Atrasentan 0.2 mg/mL solution|DRUG: 0.25 mg Atrasentan QD|DRUG: 0.75 mg Atrasentan QD|DRUG: 1.75 mg Atrasentan QD
Outcome Measures: Primary: Mean change from baseline to each post-baseline observation on UACR over the course of treatment period versus standard of care, Week 8 visit or final assessment | Secondary: Proportion of subjects achieving at least a 25% reduction in final UACR levels from baseline, Week 8 visit or final assessment|Proportion of subjects achieving at least a 40% reduction in final UACR levels from baseline, Week 8 visit or final assessment|Change from baseline to the final value in UACR, estimated glomerular filtration rate (eGFR), Neutrophil Gelatinase-Associated Lipocalin (NGAL), Week 8 visit or final assessment|Change from baseline to each weekly measurement in NGAL, Week 8 visit or final assessment
Sponsor/Collaborators: Sponsor: AbbVie (prior sponsor, Abbott)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 92
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2009-06
Completion Date: 2010-05
Results First Posted:
Last Update Posted: 2018-06-06
Locations: Site Reference ID/Investigator# 19386, Tempe, Arizona, 85284, United States|Site Reference ID/Investigator# 25043, Azusa, California, 91702, United States|Site Reference ID/Investigator# 23308, Los Angeles, California, 90022, United States|Site Reference ID/Investigator# 25430, Los Angeles, California, 90048, United States|Site Reference ID/Investigator# 20421, San Diego, California, 92123, United States|Site Reference ID/Investigator# 22442, San Diego, California, 92123, United States|Site Reference ID/Investigator# 21061, Whittier, California, 90603, United States|Site Reference ID/Investigator# 16572, Yuba City, California, 95991, United States|Site Reference ID/Investigator# 26142, Coral Gables, Florida, 33134, United States|Site Reference ID/Investigator# 16567, Hudson, Florida, 34667, United States|Site Reference ID/Investigator# 16577, Pembroke Pines, Florida, 33028, United States|Site Reference ID/Investigator# 25242, Pembroke Pines, Florida, 33028, United States|Site Reference ID/Investigator# 16569, Rockville, Maryland, 20852, United States|Site Reference ID/Investigator# 16574, Omaha, Nebraska, 68131, United States|Site Reference ID/Investigator# 20221, Buffalo, New York, 14215, United States|Site Reference ID/Investigator# 16576, Greenville, North Carolina, 27834, United States|Site Reference ID/Investigator# 16573, Morehead City, North Carolina, 28557, United States|Site Reference ID/Investigator# 26143, Statesville, North Carolina, 28625, United States|Site Reference ID/Investigator# 19383, Bethlehem, Pennsylvania, 18017, United States|Site Reference ID/Investigator# 26365, Orangeburg, South Carolina, 29115, United States|Site Reference ID/Investigator# 16571, San Antonio, Texas, 78229-4801, United States|Site Reference ID/Investigator# 16566, San Antonio, Texas, 78229, United States|Site Reference ID/Investigator# 19384, San Antonio, Texas, 78229, United States|Site Reference ID/Investigator# 24542, Fairfax, Virginia, 22030, United States|Site Reference ID/Investigator# 16564, Las Piedras, 00771, Puerto Rico|Site Reference ID/Investigator# 19381, Ponce, 00717, Puerto Rico|Site Reference ID/Investigator# 16563, San Juan, 00918, Puerto Rico|Site Reference ID/Investigator# 16562, San Juan, 00936-5067, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT00920764

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