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The AFFINITY Study


Title The AFFINITY Study: A trial for patients with kidney disease caused by Focal Segmental Glomerulosclerosis (FSGS), Immunoglobulin A (IgA) Nephropathy, Diabetic Kidney Diseases (DKD), or Alport Syndrome. 
Therapeutic Area Proteinuria, Chronic Kidney Disease, Diabetic Kidney Problems, Glomerular Disease
Principal Investigator Lesley Inker, MD, MS
Min Age 18 Years
Max Age 150 Years
Gender Any
Contact Amy Wyle
617-636-2571
awyle@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04573920

Overview

The purpose of this clinical trial is to see if the drug atrasentan is safe and effective in treating IgAN, FSGS, DKD, and Alport Syndrome. 

The study is comprised of an optional pre-screening period, screening, treatment, and follow-up periods. If you qualify, you will receive the study drug Atrasentan for up to 1 year. 

Study Details

Inclusion Criteria

  • Age 18 years or older
  • Biopsy-proven IgAN, biopsy confirmed FSGS, diagnosis of Alport syndrome by genetic testing OR clinical diagnosis of type 2 diabetes mellitus

 

Exclusion Criteria

  • History of organ transplantation
  • History of human immunodeficiency virus (HIV), hepatitis B (HBV) infection, or hepatitis C (HCV) infection
  • Intent to become pregnant or intent to father a child

If you aren't sure if you qualify, please call us and we will help determine your eligibility.

Study Requirements

This study lasts about 56 weeks. It starts with 4 weeks in which we have a screening visit to determine if you are eligible for the study; then a treatment period of 52 weeks where you take one pill a day; and ends with 4 weeks where we follow up on you after the treatment period is over.

During the course of these 60 weeks, you will have approximately 10 visits.

These visits will include blood draws of about 2 tbsp per visit. For about half the visits, you will be asked to collect your first urine of the day and/or all your urine produced for 24 hours, in special containers provided to you by the study team.

There are no x-rays or scans, but you will have an electrocardiogram (EKG) performed at 3 of the visits. If you have Alport syndrome, you will have audiograms to evaluate hearing loss at 3 visits.

Some visits must be in-person at Tufts Medical Center. There is an option to have some visits performed within your home, by a registered nurse. Women of child-bearing potential will conduct additional pregnancy tests at home and discuss results over the phone with the study team.

You will be re-imbursed for your travel and meal expenses, and will be compensated for the 24-hour urine collections.