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
NCT ID: NCT01399580
Last Updated: 2013-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2011-08-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group A - Placebo QD
Placebo
Subjects will take two tablets daily of placebo QD for 8 weeks during the treatment period.
Group B - Low dose Atrasentan QD
Atrasentan
Subjects will take two tablets daily of either low dose Atrasentan QD or high dose Atrasentan QD for 8 weeks during the treatment period.
Group C - High dose Atrasentan QD
Atrasentan
Subjects will take two tablets daily of either low dose Atrasentan QD or high dose Atrasentan QD for 8 weeks during the treatment period.
Interventions
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Atrasentan
Subjects will take two tablets daily of either low dose Atrasentan QD or high dose Atrasentan QD for 8 weeks during the treatment period.
Placebo
Subjects will take two tablets daily of placebo QD for 8 weeks during the treatment period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject has type 2 diabetes and has been treated with at least one anti-hyperglycemic medication within the 12 months prior to the Screening Period.
3. Subject is currently receiving an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin II receptor blocker (ARB) (Renin Angiotensin System (RAS) inhibitor).
4. If female, subject is not breastfeeding and is not pregnant (verified by negative serum pregnancy test prior to the Treatment Period). Subject is not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or is of childbearing potential and practicing one of the approved methods of birth control as defined in the Clinical Trial Protocol. Contraception must be used during the study and for 4 weeks after the last dose of study drug.
5. For entry into the Run-in Period the subject must satisfy the following criteria based on the Screening laboratory values:
* Estimated glomerular filtration rate (eGFR) greater than or equal to 30 and less than or equal to 75 mL/min/1.73m\^2 by the Epidemiology Collaboration (EPI) formula
* Urinary Albumin to Creatinine Ratio (UACR) greater than or equal to 300 and less than or equal to 3500 mg/g as determined by the geometric mean of the two morning void urine specimens obtained at the Screening visit
* Serum albumin greater than or equal to 3.0 g/dL
* B-Type Natriuretic Peptide (BNP) less than or equal to 200 pg/mL
* Negative serum pregnancy test for female subjects
* Systolic Blood Pressure (SBP) greater than or equal to 110 mmHg and less than or equal to 180 mmHg
* Glucosylated hemoglobin (HbA1c) less than or equal to 12%
6. For entry into the Treatment Period the subject must satisfy the following criteria based on the last visit of the Run-in Period laboratory values:
* Renin Angiotensin System (RAS) inhibitor at maximum tolerated labeled dose for the previous 4 weeks with no adjustment of dose
* Diuretic at any dose unless medically contraindicated (with the exception of loop diuretics greater than or equal to 120 mg QD of furosemide or greater than or equal to 3.0 mg QD of bumetanide or greater than or equal to 150 mg QD of ethacrynic acid or greater than or equal to 60 mg QD of torasemide)
* UACR ≥ 200 mg/g as determined by the median of the three morning void urine specimens obtained prior to the Week -1 visit
* Systolic Blood Pressure (SBP) greater than or equal to 110 mmHg and less than or equal to 160 mmHg
* Serum Potassium less than or equal to 5.5 mEq/L
* Negative serum pregnancy test for female subjects
Exclusion Criteria
2. Subject is receiving loop diuretics greater than or equal to 120 mg QD of furosemide or greater than or equal to 3.0 mg QD of bumetanide or greater than or equal to 150 mg QD of ethacrynic acid or greater than or equal to 60 mg QD of torasemide.
3. Subject has a history of pulmonary edema.
4. Subject has a history of pulmonary hypertension, or any lung diseases requiring oxygen therapy (i.e., chronic obstructive pulmonary disease, emphysema, pulmonary fibrosis).
5. Subject has a history of orthostatic hypotension within the past 6 months as defined by the presence of a supine-to-standing blood pressure decrease greater than or equal to 20 mmHg systolic or greater than or equal to 10 mmHg diastolic within 3 minutes of standing.
18 Years
ALL
No
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Blai Coll, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 58144
Phoenix, Arizona, United States
Site Reference ID/Investigator# 71034
Tempe, Arizona, United States
Site Reference ID/Investigator# 56927
Azusa, California, United States
Site Reference ID/Investigator# 70793
Azusa, California, United States
Site Reference ID/Investigator# 64027
Chula Vista, California, United States
Site Reference ID/Investigator# 54120
Concord, California, United States
Site Reference ID/Investigator# 64026
La Mesa, California, United States
Site Reference ID/Investigator# 70173
Los Angeles, California, United States
Site Reference ID/Investigator# 54121
Denver, Colorado, United States
Site Reference ID/Investigator# 56924
Boynton Beach, Florida, United States
Site Reference ID/Investigator# 56642
Hollywood, Florida, United States
Site Reference ID/Investigator# 68986
Augusta, Georgia, United States
Site Reference ID/Investigator# 56644
Chicago, Illinois, United States
Site Reference ID/Investigator# 54129
Baton Rouge, Louisiana, United States
Site Reference ID/Investigator# 68982
Pontiac, Michigan, United States
Site Reference ID/Investigator# 64023
Albany, New York, United States
Site Reference ID/Investigator# 55543
Flushing, New York, United States
Site Reference ID/Investigator# 54164
Fargo, North Dakota, United States
Site Reference ID/Investigator# 58147
Willoughby Hills, Ohio, United States
Site Reference ID/Investigator# 54123
Bethlehem, Pennsylvania, United States
Site Reference ID/Investigator# 61742
Pittsburgh, Pennsylvania, United States
Site Reference ID/Investigator# 54132
Chattanooga, Tennessee, United States
Site Reference ID/Investigator# 54108
Dallas, Texas, United States
Site Reference ID/Investigator# 54126
Greenville, Texas, United States
Site Reference ID/Investigator# 58153
Houston, Texas, United States
Site Reference ID/Investigator# 54110
Houston, Texas, United States
Site Reference ID/Investigator# 54116
North Richland Hills, Texas, United States
Site Reference ID/Investigator# 54173
Silverdale, Washington, United States
Countries
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References
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Lin CW, Mostafa NM, L Andress D, J Brennan J, Klein CE, Awni WM. Relationship Between Atrasentan Concentrations and Urinary Albumin to Creatinine Ratio in Western and Japanese Patients With Diabetic Nephropathy. Clin Ther. 2018 Feb;40(2):242-251. doi: 10.1016/j.clinthera.2017.07.011. Epub 2017 Jul 27.
Other Identifiers
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M12-830
Identifier Type: -
Identifier Source: org_study_id