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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 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.

SANCTUARY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 14, week 26, and week 50
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 14, week 26, and week 50 for reporting.

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 more

SANCTUARY 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

Find a Location

Who is running the clinical trial?

Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,303 Total Patients Enrolled
1 Trials studying Lupus Nephritis
70 Patients Enrolled for Lupus Nephritis
AlexionLead Sponsor
246 Previous Clinical Trials
39,157 Total Patients Enrolled
1 Trials studying Lupus Nephritis
70 Patients Enrolled for Lupus Nephritis
Alexion Pharmaceuticals, Inc.Lead Sponsor
253 Previous Clinical Trials
41,082 Total Patients Enrolled
1 Trials studying Lupus Nephritis
70 Patients Enrolled for Lupus Nephritis

Media Library

Ravulizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04564339 — Phase 2
Lupus Nephritis Research Study Groups: Ravulizumab: LN Cohort, Placebo: LN Cohort, Placebo: IgAN Cohort, Ravulizumab: IgAN Cohort
Lupus Nephritis Clinical Trial 2023: Ravulizumab Highlights & Side Effects. Trial Name: NCT04564339 — Phase 2
Ravulizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04564339 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What do we know about Ravulizumab from other scientific research?

"At present, there are 16 ongoing clinical trials researching ravulizumab. Of these, 13 are in phase 3. While several of the trials for ravulizumab are based in Whittier, California, there are 842 locations running clinical trials for ravulizumab globally."

Answered by AI

Have there been other tests like this one before?

"Ravulizumab has been researched since 2016. The earliest trial was completed in 2016 and was sponsored by Alexion Pharmaceuticals. Following the first trial in 2016, which involved 270 participants, Ravulizumab received its Phase 3 drug approval. Today there are 16 active studies for Ravulizumab across 193 cities and 31 countries worldwide."

Answered by AI

Does this experiment only allow those under 50 to participate?

"This study's requirements for eligible participants are that they must be between 18 and 75 years old. Out of the 567 total clinical trials, 59 are specifically for minors while 508 cater to adults over 65."

Answered by AI

How many total hospitals are participating in this research project?

"You can participate in this study at any of the 22 sites, which include locations such as Salt Lake City, S. Gate and Dallas. To limit travel time and inconvenience, please select the site that is closest to you."

Answered by AI

Are recruitment and enrollment still ongoing for this research project?

"That is correct. The information on clinicaltrials.gov affirms that this study, which began recruiting on December 11th 2020, is still looking for participants. They are aiming to have 120 patients at 22 different locations."

Answered by AI

What are the conditions that ravulizumab has been most effective in treating?

"Ravulizumab is an effective medical intervention for disease activity, and can also help patients that suffer from conditions including hemolysis, thrombotic microangiopathies, atypical hemolytic uremic syndrome."

Answered by AI

Has the federal government given its stamp of approval to Ravulizumab?

"Because there is only preliminary data supporting its safety, Ravulizumab was given a score of 2."

Answered by AI

How many test subjects are in this experiment?

"That is correct. The clinical trial listing on the website says that this study is actively recruiting patients at 22 locations. They are looking to enroll 120 individuals in total."

Answered by AI

Would I be a good candidate for this research?

"Eligible patients for this study must have lupus nephritis, be aged 18-75, and meet the following criteria: being vaccinated against meningococcal infection, having proteinuria ≥1 (gram [g]/day or g/g), clinically active LN that requires/is receiving immunosuppression induction treatment, vaccinated for Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae according to national/local regulatory requirements, diagnosis of active focal or diffuse proliferative LN Class III or IV, diagnosis of primary IgAN, compliance with stable and optimal dose of ren"

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
2020. "Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04564339.
All > Lupus Nephritis > Iga Nephropathy
~31 spots leftby Jun 2025
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