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Atrasentan for Kidney Disease (AFFINITY Trial)
AFFINITY Trial Summary
This trial is studying how well atrasentan works in treating patients with proteinuric glomerular disease.
AFFINITY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAFFINITY Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 2 trial • 20 Patients • NCT02118714AFFINITY Trial Design
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Who is running the clinical trial?
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- I have been on a steady dose of an SGLT2 inhibitor for 3 months.Your body mass index (BMI) is less than or equal to 40 kg/m2.I have been on a stable dose of RAS inhibitor therapy for at least 12 weeks.You have a biopsy-proven IgA nephropathy.I am 18 years or older with IgAN, FSGS, or Alport Syndrome.I am between 18 and 70 years old.I have been diagnosed with type 2 diabetes.You have eGFR of 30 mL/min/1.73 m2 or higher.I am between 18 and 70 years old.I have a chronic kidney condition not caused by my current kidney disease.I have been on a stable, maximum dose of RAS inhibitor therapy for 12 weeks.Urine protein-to-creatinine ratio (UPCR) is between 0.5 and less than 1.I have a significant history of liver problems.
- Group 1: Atrasentan 0.75 mg
- Group 2: Atrasentan 1.5 mg
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 30 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 4 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 1 Months after you stop receiving the treatment.
Frequently Asked Questions
Has a similar trial been conducted before?
"In 2020, Atrasentan was firstly investigated by Chinook Therapeutics U.S., Inc.. Subsequent to this initial trial of 380 participants, it attained its Phase 3 endorsement. Nowadays there are two in-progress trials for Atrasentan taking place across 17 countries and 43 cities."
How many geographic areas are encompassing this clinical trial?
"This research is being conducted in 18 distinct clinics. Locations include Temple Terrace, Winston-Salem and El Paso to mention a few. To lessen the strain of potential travel expenses, it may be beneficial to choose a medical centre closest to your home if you decide to partake."
Has Atrasentan been granted acceptance by the Federal Drug Administration?
"Early clinical data suggests that Atrasentan is safe, leading our team at Power to rate it as a 2 on the safety scale. While there has been some evaluation of its security, no studies have yet evaluated its efficacy."
How many participants have been accepted into this medical trial so far?
"In order for the Chinook Therapeutics U.S., Inc.-sponsored trial to commence, 100 eligible patients must first be recruited from designated medical centres such as Elixia Tampa, LLC in Temple Terrace, Florida and Brookview Hills Research Associates, LLC in Winston-Salem, North carolina."
Are there currently any openings in this clinical research program?
"The information hosted on clinicaltrials.gov confirms that this study is actively seeking participants as of July 25th 2022, having first been posted on February 1st 2021."
Are there any precedential trials involving Atrasentan?
"Currently, two trials for Atrasentan are in progress. One is already on Phase 3; the other trial sites span 158 locations around St Leonards, New South Wales."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- University of Minnesota Health Clinical Research Unit- A UMPhysicians Clinic: < 48 hours
Average response time
- < 2 Days
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