Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
SANCTUARY
Phase 2 ALXN1210-NEPH-202 Study
Brief Description
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.
Site Name
Stanford, CA
94305
Sponsor
Alexion, Astra Zeneca Rare Disease
Study Drug
ALXN1210 also known as ravulizumab or ULTOMIRIS
Estimated enrollment
120
Estimated end date
September 2024
Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
SANCTUARY
Phase 2 ALXN1210-NEPH-202 Study
Brief Description
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.
Trial is for people with
IgA Nephropathy or Lupus Nephritis
Study Goal
This randomized placebo-controlled dose-finding study is to evaluate the safety of ALXN1210 in adult participants with Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN).
What is involved for the Patient?
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.
About the drug or intervention
The study medication is administered intravenously every 8 weeks.