About the RestoreD Study
The RestoreD Study is evaluating an oral investigational medication for adults between 18 and 75 years of age who have been diagnosed with proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN).
Who May Qualify
Eligible participants must:
- Be between 18 and 75 years of age
- Have proteinuria (high levels of protein in their urine)
- Have a confirmed diagnosis of LN (a form of systemic lupus erythematosus [SLE]) or primary IgAN. Participants with LN must have an active renal flare.
- For IgAN participants: be on a stable dose of renin–angiotensin system (RAS) inhibitor treatment that
includes one of the following for at least three months:
- An angiotensin-converting enzyme (ACE) inhibitor
OR - An angiotensin II receptor blocker (ARB) dose
- An angiotensin-converting enzyme (ACE) inhibitor
There are additional eligibility criteria, which the study team will discuss with you.
About the Investigational Medication
In this clinical research study, the oral investigational medication (ALXN2050) is being compared with a placebo while all participants are receiving standard of care. A placebo is a drug that contains no active ingredients and allows researchers to more fully understand the effects of an investigational medication. ALXN2050 or a placebo will be taken orally twice a day. Participants will be chosen at random to receive either a high dose or a low dose of ALXN2050 or the placebo.
Study Participation
Participation in the study lasts a little over three years and consists of the following periods:
Screening
This period may last up to six weeks. The study team will perform several assessments and procedures to determine whether interested individuals are eligible to participate.
Blinded Initial Evaluation
This period lasts approximately 26 weeks. After randomization, participants will receive their study treatment and attend visits at the study site for routine assessments and procedures. “Blinded” means that neither you nor the study doctor will know whether you are receiving the investigational medication or the placebo.
Blinded Extended Treatment
This period lasts approximately 24 weeks. Participants who were receiving the investigational medication will continue to take the same dose level. Participants with IgAN who were receiving the placebo in the initial evaluation period will now receive one of two dose levels of the investigational medication. Participants with LN initially receiving the placebo will continue to receive the placebo in this period.
Open-Label Extension
After completing the blinded initial evaluation and blinded extended treatment period, participants can enter an approximately two-year open-label extension period, in which all participants will have the opportunity to receive the investigational medication.
Safety Follow-Up
Participants will complete a safety follow-up visit 30 days after their final dose of the investigational medication.
Please note: This website is for US residents only. If you live outside the US or want additional information on the RestoreD Study, please contact ClinicalTrials@Alexion.com or call (+1) 855-752-2356.
Throughout your study participation, the study doctor may perform a number of tests and procedures, including but not limited to:
Medical history review
Physical exam
Vital sign measurements
Electrocardiogram
Pregnancy test (if applicable)
Blood and urine sample collections