RestoreD, a study evaluation of an oral investigational medication for adults between 18-75 years of age who have been diagnosed with lupus nephritis (LN) or immunoglobulin a nephropathy (IgAN)
Study Title:
A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
Study Sponsor:
Alexion, Astra Zeneca Rare Disease
Purpose of Study:
The purpose of the RestoreD Study is to evaluate the safety and effectiveness of an oral investigational medication, called ALXN 2050, given in addition to standard of care and compared with placebo in reducing symptoms in adults with LN and IgAN.
What is the Study Goal?
The primary goal of the study is to evaluate the effectiveness of ALXN2050 in reducing level of protein in urine in participants with LN or IgAN
Before you choose to participate, you should speak with your doctor.
Eligible Participants Must:
- Be between 18 and 75 years of age
- Have a confirmed diagnosis of LN (a form of systemic lupus erythematosus [SLE]) or primary IgAN based on kidney biopsy. Participants with LN must have an active renal lare
- Be on a stable dose of renin–angiotensin system (RAS) inhibitor treatment that includes one of the following for at least three months (for IgAN participants):
- An angiotensin-converting enzyme (ACE) inhibitor OR - An angiotensin II receptor blocker (ARB) dose
- Have proteinuria (high levels of protein in their urine)
Additional eligibility requirements apply. The investigational medication and study-related tests and procedures will be provided at no cost. The study team will discuss reimbursement for other expenses, such as travel.
Study Type:
- Phase II
- Double Blinded
- Randomized
- Placebo-Controlled
Talk to your doctor and visit RestoreDstudy.com
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 or your family member living with lupus, sign up for the Lupus Foundation of America’s Research Accelerated by You (RAY®) online patient and caregiver registry, if you have not already done so. Compensation is available.