Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
NCT ID: NCT04564339
Last Updated: 2025-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
123 participants
INTERVENTIONAL
2021-01-19
2025-08-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ravulizumab: LN Cohort
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.
Ravulizumab
Dosages (loading and maintenance) will be based on the participant's body weight.
Background Therapy
Participants will receive background therapy consistent with the standard of care.
Placebo: LN Cohort
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.
Placebo
Dosages (loading and maintenance) will be based on the participant's body weight.
Background Therapy
Participants will receive background therapy consistent with the standard of care.
Ravulizumab: IgAN Cohort
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.
Ravulizumab
Dosages (loading and maintenance) will be based on the participant's body weight.
Background Therapy
Participants will receive background therapy consistent with the standard of care.
Placebo: IgAN Cohort
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.
Ravulizumab
Dosages (loading and maintenance) will be based on the participant's body weight.
Placebo
Dosages (loading and maintenance) will be based on the participant's body weight.
Background Therapy
Participants will receive background therapy consistent with the standard of care.
Interventions
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Ravulizumab
Dosages (loading and maintenance) will be based on the participant's body weight.
Placebo
Dosages (loading and maintenance) will be based on the participant's body weight.
Background Therapy
Participants will receive background therapy consistent with the standard of care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Proteinuria ≥1 (gram \[g\]/day or g/g)
* Vaccinated against meningococcal infection
* Vaccinated for Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae according to national/local regulatory requirements
For LN cohort:
* Diagnosis of active focal or diffuse proliferative LN Class III or IV
* Clinically active LN, requiring/receiving immunosuppression induction treatment
For IgAN cohort:
* Diagnosis of primary IgAN
* Compliance with stable and optimal dose of renin-angiotensin system inhibitor treatment for ≥ 3 months
Exclusion Criteria
* eGFR \< 30 milliliters/minute/1.73 meters squared
* Previously received a complement inhibitor (for example, eculizumab)
* Concomitant significant renal disease other than LN or IgAN
* History of other solid organ or bone marrow transplant
* Uncontrolled hypertension
For IgAN cohort:
* Diagnosis of rapid progressive glomerulonephritis
* Prednisone or prednisone equivalent \> 20 milligram (mg) per day for \> 14 consecutive days or any other immunosuppression within 6 months
18 Years
75 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Research Site
San Dimas, California, United States
Research Site
Santa Monica, California, United States
Research Site
South Gate, California, United States
Research Site
Stanford, California, United States
Research Site
Orlando, Florida, United States
Research Site
Plantation, Florida, United States
Research Site
Lawrenceville, Georgia, United States
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Lexington, Kentucky, United States
Research Site
Louisville, Kentucky, United States
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Boston, Massachusetts, United States
Research Site
Boston, Massachusetts, United States
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Kansas City, Missouri, United States
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New York, New York, United States
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Chapel Hill, North Carolina, United States
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Columbus, Ohio, United States
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El Paso, Texas, United States
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Houston, Texas, United States
Research Site
Herston, , Australia
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Parkville, , Australia
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Westmead, , Australia
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London, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Clermont-Ferrand, , France
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Le Kremlin-Bicêtre, , France
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Paris, , France
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Saint-Priest-en-Jarez, , France
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Strasbourg, , France
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Toulouse, , France
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Berlin, , Germany
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Essen, , Germany
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Hanover, , Germany
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Lübeck, , Germany
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Bologna, , Italy
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Brescia, , Italy
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Florence, , Italy
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Torino, , Italy
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Maastricht, , Netherlands
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Lodz, , Poland
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Anyang-si, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Barcelona, , Spain
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Lleida, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Palma de Mallorca, , Spain
Research Site
Seville, , Spain
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Valencia, , Spain
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Zaragoza, , Spain
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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New Taipei City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Edgbaston, , United Kingdom
Research Site
London, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Salford, , United Kingdom
Countries
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References
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Lafayette R, Tumlin J, Fenoglio R, Kaufeld J, Perez Valdivia MA, Wu MS, Susan Huang SH, Alamartine E, Kim SG, Yee M, Kateifides A, Rice K, Garlo K, Barratt J; SANCTUARY Study Investigators. Efficacy and Safety of Ravulizumab in IgA Nephropathy: A Phase 2 Randomized Double-Blind Placebo-Controlled Trial. J Am Soc Nephrol. 2025 Apr 1;36(4):645-656. doi: 10.1681/ASN.0000000534. Epub 2024 Oct 25.
Avasare R, Drexler Y, Caster DJ, Mitrofanova A, Jefferson JA. Management of Lupus Nephritis: New Treatments and Updated Guidelines. Kidney360. 2023 Oct 1;4(10):1503-1511. doi: 10.34067/KID.0000000000000230.
Other Identifiers
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ALXN1210-NEPH-202
Identifier Type: -
Identifier Source: org_study_id
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