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ALIGN


Title The ALIGN Study: A study for patients with the kidney disease Immunoglobulin A (IgA) Nephropathy.
Therapeutic Area Chronic Kidney Disease, Proteinuria
Principal Investigator Lesley Inker, MD
Min Age 18 Years
Gender Any
Contact Amy Wyle
617-636-2571
awyle@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04573478

Overview

The purpose of this clinical trial is to see if the drug atrasentan is safe and effective in treating IgAN. We will look at whether the drug decreases the protein levels in your urine.

The study is comprised of an optional pre-screening period, a screening period, a treatment period and a follow-up period. If you qualify, you will receive either the study drug Atrasenten or placebo for up to 2.5 years. 

Study Details

Inclusion Criteria

  • Age 18 years or older
  • Biopsy-confirmed diagnosis of IgAN at any point in time prior to study (diagnostic report must be available)

Exclusion Criteria

  • History of organ transplantation
  • History of human immunodeficiency virus (HIV), hepatitis B (HBV) infection, or untreated 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

The study is busiest at the beginning, and then gets less busy. You will start with what’s called the “screening period”, where you will have one or two office visits over the course of a month. During those visits, which will take about 3-4 hours, we will run some tests and ask to questions to make sure that you qualify for the study. The tests will include a blood draw (about 1-2.5 tablespoons per visit), a urine sample, height and weight, vital signs, an ECG, a physical exam, and asking you questions about your medical history.

If you are eligible and decide to participate in the trial, you will have visits every 1-2 weeks for a month. Then visits stretch to every 6 weeks, then every 12 weeks. Many of these visits can be done at your home, by a certified nurse from a home health service, and by talking to the study doctor over the phone or a video call. You can always have your visits done in the hospital if you prefer. These visits will involve some (but usually not all) of the tests done at the screening visit. Most visits will take about 2 hours.

For some of the visits, you will be asked to collect all the urine you produce over a 24 hour period in a container provided by the study team, or to collect your first urination of the morning in a urine cup. We will also give you a scale and ask you to weigh yourself regularly for the first few weeks of the study.