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Atrasentan

Phase 2

Nephropathy | Small molecule | Metabolic |AbbVie Inc.|Last Updated: May 7, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Atrasentan · 1 trial · 2 indications

Phase 2 1
NCT02118714Atrasentan Spermatogenesis and Testicular FunctionNephropathy
COMPLETED20 Analytics
PHASE2COMPLETED
Atrasentan Spermatogenesis and Testicular Function
NephropathyUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Subjects With a Sperm Concentration < 15 Million Per mL by Treatment Week 26
Up to 26 weeks

Percentage of Subjects with a Sperm Concentration \< 15 million per mL by Treatment Week 26. Sperm concentration was calculated as measure of the number sperm per milliliter of semen. Duplicate semen samples were collected. The average of the 2 samples were used as the value for that scheduled collection period.

Secondary Endpoints

Percentage of Participants Who Entered the Observation Period and Did Not Return to Within 15% of Baseline Sperm Concentration or Above During the 52-Week Observational Period
Up to 52 weeks after the Treatment Period
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration
From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility
From Week 0 up to Treatment Period Week 26 and Observation Observation Week 52
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
AtrasentanEXPERIMENTALAtrasentan 0.75 mg administered orally once daily (QD) for 26 weeks

Interventions

NameTypeDescription
AtrasentanDRUGAtrasentan
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Eligibility Criteria

Age Range30 Years to 75 Years
SexMALE
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Males 30 to 75 years of age * 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 Glomerula...

Countries:United StatesGermanyItalySpain
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Competitive Landscape -Diabetic Nephropathy 8 trials (matched to "Nephropathy")

Frequently asked questions about Atrasentan

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.