Now Enrolling People with Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) For A Research Study
Phase 2 ALXN1210-NEPH-202 Study (clinicaltrials.gov NCT04564339)
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 less than 2 years.
This clinical trial is a Phase II 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 sexually active during duration of study
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
- Phase II
- Placebo controlled
Important Note: The SANCTUARY study is fully enrolled in IgAN and no longer accepting patients; study remains open for enrollment in lupus nephritis.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. If you are a person living with lupus or a caregiver and you want to learn more about clinical trials and other research opportunities that may be right for you, sign up for the Lupus Foundation of America’s Research Accelerated by You (RAY®) patient and caregiver registry. Compensation is available.