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Atrasentan low dose group

Phase 2

Chronic Kidney Disease | Small molecule | Nephrology |AbbVie Inc.|Last Updated: Jun 6, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials4
Total Enrollment347

FDA Designations

No designations recorded

Clinical trial landscape

Atrasentan low dose group · 4 trials · 2 indications

Phase 2 4
NCT01399580A Prospective, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of Atrasentan, Including Thoracic Bioimpedance, in Type 2 Diabetic Subjects With NephropathyChronic Kidney Disease
COMPLETED48 Analytics
NCT01424319Reducing Residual Albuminuria in Subjects With Diabetes and Nephropathy With AtrasentanChronic Kidney Disease
COMPLETED58 Analytics
NCT01356849Evaluate 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) InhibitorChronic Kidney Disease
COMPLETED149 Analytics
NCT00920764A Study of Atrasentan on Reducing Albuminuria in Type 2 Diabetic Nephropathy Treated With Renin-Angiotensin System InhibitorsChronic Kidney Disease
COMPLETED92 Analytics
PHASE2COMPLETED
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
Chronic Kidney DiseaseUnlock trial analytics
PHASE2COMPLETED
Reducing Residual Albuminuria in Subjects With Diabetes and Nephropathy With Atrasentan
Chronic Kidney DiseaseUnlock trial analytics
PHASE2COMPLETED
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
Chronic Kidney DiseaseUnlock trial analytics
PHASE2COMPLETED
A Study of Atrasentan on Reducing Albuminuria in Type 2 Diabetic Nephropathy Treated With Renin-Angiotensin System Inhibitors
Chronic Kidney DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline to each post-baseline visit up to Week 8 in log-transformed Urinary Albumin to Creatinine Ratio (UACR)
Every two weeks for 8 weeks
The change from baseline to each post-baseline visit in log-transformed UACR (urinary albumin to creatinine ratio)
Up to Week 12
Change from baseline to Week 12 in Urinary Albumin to Creatinine Ratio (UACR)
Every two weeks for 12 weeks
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 Endpoints

Change from baseline to each post baseline measure for estimated glomerular filtration rate (eGFR)
Every two weeks for 8 weeks
The change from baseline to each post-baseline assessment of thoracic bioimpedance
Treatment Day 1, Week 1, 2, 4, 6, 8 and 30 days post-treatment
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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group A - Placebo QDPLACEBO_COMPARATOR -
Group B - Low dose Atrasentan QDACTIVE_COMPARATOR -
Group C - High dose Atrasentan QDACTIVE_COMPARATOR -
ABT-627, Low doseEXPERIMENTAL -
ABT-627, High doseEXPERIMENTAL -
ABT-627, PlaceboPLACEBO_COMPARATOR -
AACTIVE_COMPARATOR -
BACTIVE_COMPARATOR -
CACTIVE_COMPARATOR -
DPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
AtrasentanDRUGSubjects will take two tablets daily of either low dose Atrasentan QD or high dose Atrasentan QD for 8 weeks during the treatment period.
PlaceboDRUGSubjects will take two tablets daily of placebo QD for 8 weeks during the treatment period.
Atrasentan low dose groupDRUGSubjects 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 groupDRUGSubjects 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 groupDRUGSubjects 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 solutionDRUG10 mL oral solution, daily, 8 weeks
0.25 mg Atrasentan QDDRUG10 mL oral solution, daily, 8 weeks
0.75 mg Atrasentan QDDRUG10 mL oral solution, daily, 8 weeks
1.75 mg Atrasentan QDDRUG10 mL oral solution, daily, 8 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites28

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...

Countries:United StatesJapanCanadaPuerto RicoTaiwan
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Frequently asked questions about Atrasentan low dose group

What is Atrasentan used for?

Atrasentan is an investigational small molecule being developed for chronic kidney disease and nephropathy, specifically diabetic nephropathy. It is studied for its effect on reducing albuminuria in patients with type 2 diabetic nephropathy who are treated with renin-angiotensin system inhibitors.

Who makes Atrasentan?

Atrasentan is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The drug is currently in Phase 2 clinical development for chronic kidney disease and nephropathy.

What phase is Atrasentan in?

Atrasentan is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Four Phase 2 clinical trials have been completed, with no active trials currently ongoing.

What clinical trials is Atrasentan in?

Atrasentan has completed four Phase 2 clinical trials. These include NCT00920764, NCT01356849, NCT01399580, and NCT01424319. All trials focused on chronic kidney disease and diabetic nephropathy, with a total enrollment of 347 participants across the United States, Canada, Puerto Rico, Taiwan, and Japan.

Is Atrasentan the same as ABT-627?

Atrasentan is also known by the code name ABT-627. It is an investigational small molecule being studied for chronic kidney disease and nephropathy. The drug is in Phase 2 development and has completed four clinical trials.