What side effects are associated with this type of intervention?

Common treatments for Lupus Nephritis, including immunosuppressive therapies like cyclophosphamide, mycophenolate mofetil, and corticosteroids, often have side effects such as increased risk of infections, gastrointestinal disturbances, and bone marrow suppression. Specific to terminal complement inhibitors like Ravulizumab, potential side effects may include infusion reactions, headache, and increased susceptibility to infections due to the suppression of the complement system.

What prior FDA approvals exist?

The FDA has approved several treatments for Lupus Nephritis, including immunosuppressive therapies like mycophenolate mofetil and cyclophosphamide. More recently, the FDA approved belimumab, a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS), for the treatment of Lupus Nephritis. While not specifically a terminal complement inhibitor like Ravulizumab, belimumab represents a targeted biological therapy aimed at modulating the immune system. There is limited information on FDA-approved terminal complement inhibitors specifically for Lupus Nephritis, making Ravulizumab a novel approach in this context.

What other types of research exist?

Promising novel alternatives to Ravulizumab for Lupus Nephritis patients include voclosporin, a calcineurin inhibitor that has shown efficacy in reducing proteinuria and improving renal function, and belimumab, a monoclonal antibody targeting B-lymphocyte stimulator (BLyS), which has been approved for active LN. Both therapies offer different mechanisms of action compared to terminal complement inhibition.

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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

Must not have

For IgAN cohort: Diagnosis of rapid progressive glomerulonephritis

Common to both disease cohorts: Concomitant significant renal disease other than LN or IgAN

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 26 and week 50

Summary

This trial is testing the safety and effectiveness of a drug called ravulizumab, given through a vein, in patients with specific kidney diseases. The drug aims to reduce kidney damage by blocking part of the immune system.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a quickly worsening kidney condition.

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I do not have significant kidney disease other than lupus nephritis or IgA nephropathy.

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My kidney function is low, with an eGFR under 30.

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I haven't taken high doses of prednisone or any immunosuppressants in the last 6 months.

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I have been treated with a complement inhibitor before.

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My high blood pressure is not under control.

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I have had a solid organ or bone marrow transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 26 and week 50

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 26 and week 50

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 26 and week 50 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

IgAN Cohort: Percentage Of Participants Meeting The Criteria For Partial Remission

LN Cohort: Percentage Of Participants Meeting The Criteria For Complete Renal Response

LN Cohort: Percentage Of Participants Meeting The Criteria For Partial Renal Response

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

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

2016

Completed Phase 4

~1090

0 / 13Eligibility criteria met

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.