Now Enrolling People with Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) For A Research Study

Study Title: 

Phase 2 ALXN1210-NEPH-202 Study (clinicaltrials.gov NCT04564339) 

Study Sponsor: 

Alexion, Astra Zeneca Rare Disease 

Purpose of Study: 

The purpose of this clinical trial is to evaluate the safety and efficacy (effectiveness against  disease) of the study medication (ALXN1210 also known as ravulizumab or ULTOMIRIS ®) in  participants with lupus nephritis (LN) or immunoglobulin A nephropathy (IgAN), a rare chronic  kidney disease. 

What Does this Study Involve?  

This study will include 120 participants, 60 with LN and 60 with IgAN. The total study duration  for each participant will be approximately 2 years.  

This clinical trial is a phase 2 randomized placebo controlled clinical trial that is randomized 2:1  treatment to placebo such that if you are enrolled you are twice as likely to receive the study treatment than the placebo.  

Before you choose to participate, you should speak with your doctor. 

You May Qualify for This Study If You Are: 

• Between 18 and 75 years of age 
• Diagnosed with LN or IgAN based on a kidney biopsy 
• Have protein in your urine (equal to or more than 1gram/day) 
• Have kidney function with eGFR >/= 30 mL/min/1.73m2 
• Willing to complete 24-hour urine collections (collection of urine over a 24-hour period  to assess for protein, which can be scheduled in advance and can be done at home)
• Willing to use reliable form of contraception (birth control) 

If you have any of the following, you may not be able to participate in the study: 

• Kidney or other organ transplant
• History of meningitis infection (nisseria meningitis)
• Pregnant or breast-feeding 

Study Type: 

• Phase II  
• Randomized  
• Placebo controlled  

Learn More by visiting www.clinicaltrials.gov using reference number NCT04564339 or call Alexion at 855-752-2356 or email clinicaltrials@alexion.com. 

Choosing to participate in a study is an important personal decision. Be sure to have an open  conversation with your doctor. It is important to understand all of your options before deciding  what is right for you. Choosing to be in a clinical trial is voluntary. For more information about  clinical trials, visit our Featured Research Studies page.