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Alexion TMAS


Title A study to evaluate the efficacy and safety of Ravulizumab (ALXN1210) in patients with Thrombotic Microangiopathy (TMA) associated with a trigger 
Therapeutic Area Thrombotic Microangiopathy (TMA), Kidney Diseases
Principal Investigator Craig E. Gordon MD, MS
Min Age 18 Years
Gender All
Contact Jasmine Pak
617-636-2609
jpak@tuftsmedicalcenter
More Information https://clinicaltrials.gov/ct2/show/NCT04743804

Overview

The purpose of this trial is to see if the drug ravulizumab  is safe and effective in patients with thrombotic microangiopathy (TMA). This study is double-blind and placebo-controlled, meaning that neither you nor the study team will know if you are assigned to take the real drug or a saline solution. There is a 50% chance that you will recieve the drug. You will recieve the drug or placebo for about 6 months and then have follow-up appoinments for about 6 months. 

Study Details

Inclusion Criteria

  • Diagnosis of TMA

Exclusion Criteria

  • History of cancer <5 years ago (with some exceptions)
  • Known chronic kidney disease with estimated GFR <45 mL/min/1.73^2

Study Requirements

This study involves a screening visit, 13 visits during the 26 week treatment period, and 3 visits during the 26 week follow up period. Some study visits include blood draws and urine collections. No x-rays/CT scans/MRIs are required by the study.