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The AFFINITY Study


Title Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases
Therapeutic Area Proteinuria
Principal Investigator Lesley Inker, MD, MS
Min Age 18 Years
Max Age 150 Years
Gender Any
Contact Leah Meyer
617-636-5895
lmeyer@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04573920

Overview

Study Details

Inclusion Criteria

  • eGFR of greater than or equal to 30 mlL/min/1.73 m2
  • Diagnosis of one of the following: IgAN (IgA Nephropathy); FSGS (focal segmental glomerulosclerosis); Alport Syndrome; Diabetic Kidney Disease
  • Protein in the urine (UPCR), also known as urine protein to creatinine ratio) in the relevant range for your diagnosis. Note that you will have this test run as part of the process.

For IgAN: UPCR greater than or equal to 0.5 and less than 1.0 g/g

  For FSGS: UPCR greater than 1.5 g/g

  For Alport Syndrome: UPCR greater than 0.5 g/g

  For Diabetic Kidney Disease: UACR (urine albumin to creatinine ratio) greater than or equal to 0.5 g/g

 

Exclusion Criteria

  • Known history of congestive heart failure
  • History of organ transplantation
  • History of malignancy unless cancer free for at least 5 years, or if malignancy is nonmelanoma skin cancer not requiring ongoing treatment

Study Requirements

This study lasts about 60 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.