Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01399580 | 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 | PHASE2 | COMPLETED | 48 | — | — | Aug 1, 2011 | Sep 1, 2012 | Oct 25, 2013 | 28 | United States |
| NCT01424319 | Reducing Residual Albuminuria in Subjects With Diabetes and Nephropathy With Atrasentan | PHASE2 | COMPLETED | 58 | — | — | Aug 1, 2011 | Jul 1, 2012 | Aug 29, 2017 | 18 | Japan |
| NCT01356849 | Evaluate the Efficacy and Safety of Once Daily Administration of Atrasentan Tablets (Low and High) Compared to Placebo in Reducing Residual Albuminuria in Type 2 Diabetic Patients With Nephropathy Who Are Treated With the Maximum Tolerated Labeled Dose of a Renin Angiotensin System (RAS) Inhibitor | PHASE2 | COMPLETED | 149 | — | — | Apr 1, 2011 | Aug 1, 2012 | Aug 28, 2013 | 72 | United States, Canada +2 |
| NCT00920764 | A Study of Atrasentan on Reducing Albuminuria in Type 2 Diabetic Nephropathy Treated With Renin-Angiotensin System Inhibitors | PHASE2 | COMPLETED | 92 | — | — | Jun 1, 2009 | May 1, 2010 | Jun 6, 2018 | 28 | United States, Puerto Rico |
| Arm | Type | Description |
|---|---|---|
| Group A - Placebo QD | PLACEBO_COMPARATOR | - |
| Group B - Low dose Atrasentan QD | ACTIVE_COMPARATOR | - |
| Group C - High dose Atrasentan QD | ACTIVE_COMPARATOR | - |
| ABT-627, Low dose | EXPERIMENTAL | - |
| ABT-627, High dose | EXPERIMENTAL | - |
| ABT-627, Placebo | PLACEBO_COMPARATOR | - |
| A | ACTIVE_COMPARATOR | - |
| B | ACTIVE_COMPARATOR | - |
| C | ACTIVE_COMPARATOR | - |
| D | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Atrasentan | DRUG | 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 | DRUG | Subjects will take two tablets daily of placebo QD for 8 weeks during the treatment period. |
| 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. |
| 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. |
| Placebo for Atrasentan 0.2 mg/mL solution | DRUG | 10 mL oral solution, daily, 8 weeks |
| 0.25 mg Atrasentan QD | DRUG | 10 mL oral solution, daily, 8 weeks |
| 0.75 mg Atrasentan QD | DRUG | 10 mL oral solution, daily, 8 weeks |
| 1.75 mg Atrasentan QD | DRUG | 10 mL oral solution, daily, 8 weeks |
Inclusion Criteria: 1. Subject is greater than or equal to 18 years old. 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 inhibit...