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Monoclonal Antibodies
Ravulizumab for Lupus Nephritis and IgA Nephropathy (SANCTUARY Trial)
Phase 2
Recruiting
Research Sponsored by Alexion Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For IgAN cohort: Diagnosis of primary IgAN
Common to both disease cohorts: Vaccinated against meningococcal infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 14, week 26, and week 50
Awards & highlights
SANCTUARY Trial Summary
This trial is testing a new drug to see if it's safe and effective for treating lupus nephritis or IgA nephropathy.
Who is the study for?
This trial is for people with severe kidney inflammation due to Lupus Nephritis (LN) or IgA Nephropathy (IgAN). Participants must have protein in their urine and be vaccinated against certain infections. Those with LN need active disease treatment, while those with IgAN should be on stable blood pressure medication. People can't join if they have very low kidney function, used complement inhibitors before, have other major kidney diseases, uncontrolled high blood pressure, or recent heavy use of steroids/immunosuppressants.Check my eligibility
What is being tested?
The study tests Ravulizumab's safety and effectiveness compared to a placebo in patients with LN or IgAN. All participants will continue their usual treatments too. Ravulizumab is given through an IV infusion to see if it can help by blocking part of the immune system that damages the kidneys.See study design
What are the potential side effects?
Ravulizumab may cause side effects like headache, nausea, and higher risk of infections due to its impact on the immune system. It might also lead to reactions at the infusion site or rare but serious conditions related to blood clots or breakdown.
SANCTUARY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with primary IgA nephropathy.
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I have been vaccinated against meningitis.
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I am vaccinated for Hib and pneumonia as required.
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I am currently being treated for active lymph node issues with strong medication.
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My lupus has caused severe kidney inflammation.
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I am currently receiving treatment for active lupus nephritis.
SANCTUARY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 14, week 26, and week 50
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 14, week 26, and week 50
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Both Cohorts: Percentage Change In Proteinuria From Baseline To Week 26 Assessed Using 24-hour Urine Collections
Secondary outcome measures
Both Cohorts: Change In Estimated Glomerular Filtration Rate (eGFR) From Baseline At Week 26 And Week 50
Both Cohorts: Percentage Change In Proteinuria From Baseline To Week 50 Assessed Using 24-hour Urine Collections
IgAN Cohort: Percentage Of Participants Meeting The Criteria For Partial Remission
+6 moreSANCTUARY Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Ravulizumab: LN CohortExperimental Treatment2 Interventions
Eligible participants will receive ravulizumab IV infusion in combination with background therapy during both the Initial Evaluation Period (26 weeks) and Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.
Group II: Ravulizumab: IgAN CohortExperimental Treatment2 Interventions
Eligible participants will receive ravulizumab IV infusion in combination with background therapy during both the Initial Evaluation Period (26 weeks) and Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.
Group III: Placebo: LN CohortPlacebo Group2 Interventions
Eligible participants will receive placebo IV infusion in combination with background therapy during both the Initial Evaluation Period (26 weeks) and Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.
Group IV: Placebo: IgAN CohortPlacebo Group3 Interventions
Eligible participants will receive placebo IV infusion in combination with background therapy during the Initial Evaluation Period (26 weeks) and will switch to ravulizumab for the Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ravulizumab
2021
Completed Phase 4
~1080
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Lupus Nephritis (LN) treatments often target the immune system to reduce inflammation and prevent kidney damage. Terminal complement inhibition, such as with Ravulizumab, works by blocking the complement system, a part of the immune response that can contribute to inflammation and tissue damage in LN.
This is crucial for LN patients as it helps to prevent the progression of kidney damage and preserve kidney function. Other common treatments include immunosuppressive drugs like cyclophosphamide and mycophenolate mofetil, which reduce the activity of the immune system overall, and corticosteroids, which decrease inflammation.
These treatments aim to control the autoimmune activity that characterizes LN, thereby reducing symptoms and preventing long-term kidney damage.
Advances in drug therapy for systemic lupus erythematosus.
Advances in drug therapy for systemic lupus erythematosus.
Find a Location
Who is running the clinical trial?
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,301 Total Patients Enrolled
1 Trials studying Lupus Nephritis
70 Patients Enrolled for Lupus Nephritis
AlexionLead Sponsor
246 Previous Clinical Trials
39,155 Total Patients Enrolled
1 Trials studying Lupus Nephritis
70 Patients Enrolled for Lupus Nephritis
Alexion Pharmaceuticals, Inc.Lead Sponsor
254 Previous Clinical Trials
41,115 Total Patients Enrolled
1 Trials studying Lupus Nephritis
70 Patients Enrolled for Lupus Nephritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with primary IgA nephropathy.I have been diagnosed with a quickly worsening kidney condition.I have been vaccinated against meningitis.I am vaccinated for Hib and pneumonia as required.I am currently being treated for active lymph node issues with strong medication.I do not have significant kidney disease other than lupus nephritis or IgA nephropathy.My kidney function is low, with an eGFR under 30.I haven't taken high doses of prednisone or any immunosuppressants in the last 6 months.I have been on a stable dose of medication for my kidney condition for over 3 months.My lupus has caused severe kidney inflammation.I have been treated with a complement inhibitor before.My high blood pressure is not under control.You have high levels of protein in your urine, at least 1 gram per day.I have had a solid organ or bone marrow transplant.I am currently receiving treatment for active lupus nephritis.
Research Study Groups:
This trial has the following groups:- Group 1: Ravulizumab: LN Cohort
- Group 2: Placebo: LN Cohort
- Group 3: Placebo: IgAN Cohort
- Group 4: Ravulizumab: IgAN Cohort
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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