Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2015-04-06
2018-07-16
Brief Summary
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This study included 2 periods: a Treatment Period (up to 26 weeks) followed by an Observational Period (up to an additional 52 weeks).
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Atrasentan
Atrasentan 0.75 mg administered orally once daily (QD) for 26 weeks
Atrasentan
Atrasentan
Interventions
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Atrasentan
Atrasentan
Eligibility Criteria
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Inclusion Criteria
* Type 1 or 2 diabetes and receiving treatment with at least one anti-hyperglycemic medication and angiotensin-converting enzyme inhibitors (ACEi)/angiotensin receptor blockers (ARB) (renin-angiotensin system \[RAS\] inhibitor)
* Estimated Glomerular Filtration Rate (eGFR) equal to or greater than 35 mL/min/1.73 m\^2 with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Formula and Urine Albumin-to-Creatinine Ratio (UACR) equal to or greater than 30 and less than 5,000 mg/g creatinine.
* Able to provide a semen specimen at the required intervals.
* Baseline sperm concentration equal to or greater than 30 million per mL.
Exclusion Criteria
* History of severe peripheral edema or facial edema unrelated to trauma or history of myxedema in the prior 4 weeks prior to screening.
* History of pulmonary hypertension, pulmonary fibrosis or any lung disease requiring oxygen therapy.
* Documented diagnosis of heart failure, previous hospitalization for heart failure or current or constellation of symptoms (dyspnea on exertion, pedal edema, orthopnea, paroxysmal nocturnal dyspnea) felt to be compatible with heart failure, that was not explained by other causes, and for which there was a change in medication or other management directed at heart failure.
* Currently receiving or has received hormone replacement therapy within 6 months prior to screening.
30 Years
75 Years
MALE
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Alliance Research Centers /ID# 125945
Laguna Hills, California, United States
Frank Clark Urology Center /ID# 147794
Santa Monica, California, United States
Research by Design, LLC /ID# 160784
Evergreen Park, Illinois, United States
Southern IL Univ School of Med /ID# 129010
Springfield, Illinois, United States
Crescent City Clinical Res Ctr /ID# 150989
Metairie, Louisiana, United States
Tulane Univ /ID# 130308
New Orleans, Louisiana, United States
Albany Medical College /ID# 131068
Albany, New York, United States
Urologic Consultants of Southeastern Pennsylvania /ID# 124277
Bala-Cynwyd, Pennsylvania, United States
Eastern Virginia Med School /ID# 153740
Norfolk, Virginia, United States
Charite Research Organisation GmbH /ID# 154264
Berlin, , Germany
Ospedale S. Carlo Borromeo /ID# 151672
Milan, , Italy
SCDU Nefrologia e dialisi-CMID /ID# 151673
Torino, , Italy
Hospital Universitario Reina S /ID# 151692
Córdoba, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-000722-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M12-919
Identifier Type: -
Identifier Source: org_study_id
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