About the SANCTUARY Study
The SANCTUARY Study is evaluating the effectiveness and safety of an investigational medication in adults who have proliferative lupus nephritis (LN) or immunoglobulin A nephropathy (IgAN).
Who May Qualify
Eligible participants must:
- Be 18 to 75 years of age
- Have a diagnosis of LN or IgAN
- Not have a history of kidney transplant or plan to undergo a transplant during the treatment period
- Not have a history of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow transplant, or plan to undergo a transplant during the study
There are additional eligibility requirements that the study doctor can explain to you.
About the Investigational Medication
The investigational medication is called ravulizumab. “Investigational” means that it has not been approved by country-specific regulatory health authorities to be used for proliferative LN or IgAN, and its use is being allowed for research purposes only. Ravulizumab has been approved by the FDA for use in the treatment of other diseases.
Participants will be assigned at random to receive either ravulizumab or a placebo, but the study is 2:1 randomized treatment to placebo, which means that all participants are twice as likely to receive the investigational medication as the placebo. A placebo looks just like the investigational medication but contains no active ingredients. Neither the participant nor the study team will know which treatment option has been assigned, but in case of an emergency, the study team can quickly find out. After the first six months, patients receiving IgAN placebo will cross over to receive the investigational medication. The investigational medication will be administered as an intravenous (IV) infusion.
Study Participation
The total duration of participation in the SANCTUARY Study will be approximately 20 months and consists of:
Screening
This period will last up to six weeks and include one on-site visit. During this time, the study team will review your medical history and perform tests to see if you qualify for the study.
Treatment
Those who qualify and agree to participate are selected at random to receive either the investigational medication or a placebo. Participants will be assigned at random to receive either ravulizumab or a placebo. The study is 2:1 randomized treatment to placebo, which means that all participants are twice as likely to receive the investigational medication as the placebo. The study doctor will perform procedures and assessments during study site visits to check on your health. This period will consist of a six-month initial evaluation period and an extension period of approximately 50 weeks of treatment and 14 visits.
- IgAN participants who are in the placebo group will cross over to receive ravulizumab after the first six months of treatment.
Follow-Up
The study doctor will continue to check on your health for approximately eight months after the treatment period has ended. This will require no on-site visits.
Please note: This website is for US residents only. If you live outside the US or want additional information on the SANCTUARY Study, please email 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