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Prospective, randomized, double-blind, placebo controlled, 12-week, multicenter study. The objective of the study is to evaluate the efficacy and safety of once daily administration of atrasentan tablets compared to placebo in reducing residual albuminuria in Japanese Type 2 diabetic patients with nephropathy who are treated with the maximum tolerated labeled dose for hypertension of a RAS (renin angiotensin system) inhibitor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-627, Low dose | Experimental |
| |
| ABT-627, High dose | Experimental |
| |
| ABT-627, Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atrasentan low dose group | Drug | Subjects will take two tablets daily of one of those which are atrasentan low dose, atrasentan high dose or atrasentan placebo for 12 weeks during the treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline to each post-baseline visit in log-transformed UACR (urinary albumin to creatinine ratio) | Up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mosleh UDDIN, PharmD | Abbott Japan Co.,Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 62022 | Azumino | Japan | ||||
| Site Reference ID/Investigator# 58124 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24722445 | Result | de Zeeuw D, Coll B, Andress D, Brennan JJ, Tang H, Houser M, Correa-Rotter R, Kohan D, Lambers Heerspink HJ, Makino H, Perkovic V, Pritchett Y, Remuzzi G, Tobe SW, Toto R, Viberti G, Parving HH. The endothelin antagonist atrasentan lowers residual albuminuria in patients with type 2 diabetic nephropathy. J Am Soc Nephrol. 2014 May;25(5):1083-93. doi: 10.1681/ASN.2013080830. Epub 2014 Apr 10. | |
| 26153128 |
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| Atrasentan high dose group | Drug | Subjects will take two tablets daily of one of those which are atrasentan low dose, atrasentan high dose or atrasentan placebo for 12 weeks during the treatment period. |
|
| Atrasentan placebo group | Drug | Subjects will take two tablets daily of one of those which are atrasentan low dose, atrasentan high dose or atrasentan placebo for 12 weeks during the treatment period. |
|
| 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 |
| 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 | Kōriyama | Japan |
| Site Reference ID/Investigator# 56524 | Matsumoto | Japan |
| Site Reference ID/Investigator# 57242 | Nagano | Japan |
| Site Reference ID/Investigator# 55781 | Nagoya | Japan |
| Site Reference ID/Investigator# 60965 | 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 |
| Result |
| Kohan DE, Lambers Heerspink HJ, Coll B, Andress D, Brennan JJ, Kitzman DW, Correa-Rotter R, Makino H, Perkovic V, Hou FF, Remuzzi G, Tobe SW, Toto R, Parving HH, de Zeeuw D. Predictors of Atrasentan-Associated Fluid Retention and Change in Albuminuria in Patients with Diabetic Nephropathy. Clin J Am Soc Nephrol. 2015 Sep 4;10(9):1568-74. doi: 10.2215/CJN.00570115. Epub 2015 Jul 7. |
| 28756065 | Derived | 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. |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003928 | Diabetic Nephropathies |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077868 | Atrasentan |
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D052117 | Benzodioxoles |
| D004149 | Dioxoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011759 | Pyrrolidines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003710 | Demography |
| D011154 | Population Characteristics |
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