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NCT04564339CompletedPhase 2

Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 4 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Efficacy of ravulizumab compared with placebo in adult participants with LN and IgAN

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
87 (actual)
First submitted
31 Jan 2024
Start date
10 May 2021
Lead sponsor
Alexion Pharmaceuticals Inc.
NCT number
NCT04564339
EU CT number
2023-507977-16-00
EudraCT number
2020-001537-13

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 87
  • 31 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Lab values

  • Common to both disease cohorts: - Estimated GFR < 30 mL/min/1.73 m^2 - Previously received a complement inhibitor (eg, eculizumab) at any time - Concomitant significant renal disease other than LN or IgAN - History of kidney transplant or planned kidney transplant during the Treatment Period - History of other solid organ or bone marrow transplant - Uncontrolled hypertension For IgAN cohort: - Diagnosis of rapid progressive glomerulonephritis - Prednisone or prednisone equivalent > 20 mg for > 14 consecutive days or any other immunosuppression within 6 months For a full list of exclusion criteria please refer to the clinical study protocol, section 5.2.

Who the study is looking for

  • Common to both disease cohorts: - 18 - 75 years of age - Proteinuria ≥ 1 (g/d or g/g) - Vaccinated against meningococcal infection - Vaccinated against Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae For LN cohort: - Diagnosis of active focal or diffuse proliferative LN Class III or IV - Clinical active LN, requiring/receiving immunosuppression induction treatment For IgAN cohort: - Diagnosis of primary IgAN - Compliance with stable and optimal dose of RAS inhibitor treatment for ≥ 3 months For a full list of inclusion criteria please refer to the clinical study protocol, section 5.1.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (31)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyCompleted
Universitaetsklinikum Essen (AoR)
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EssenGermanyCompleted
Medizinische Hochschule Hannover
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HanoverGermanyCompleted
Universitaetsklinikum Schleswig-Holstein AöR
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LuebeckGermanyCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital General Universitario de Ciudad Real
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Ciudad RealSpainCompleted
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
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LleidaSpainCompleted
Hospital General Universitario Gregorio Marañón
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MadridSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario Regional de Málaga
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MálagaSpainCompleted
University Hospital Son Espases
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PalmaSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Hospital Universitario Dr. Peset Aleixandre
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ValenciaSpainCompleted
Hospital Unviersitario Miguel Servet
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ZaragozaSpainCompleted
Chu Gabriel Montpied
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Clermont-FerrandFranceCompleted
Assistance Publique Hopitaux De Paris
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Le Kremlin-BicetreFranceCompleted
Centre Hospitalier Universitaire de Montpellier
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MontpellierFranceCompleted
Hopital Tenon
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Paris Cedex 20FranceCompleted
Centre Hospitalier Universitaire De Saint Etienne
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St Etienne Cedex 2FranceCompleted
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceCompleted
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceCompleted
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyCompleted
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyCompleted
Careggi University Hospital
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FlorenceItalyCompleted
Azienda Ospedaliero - Universitaria di Modena
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ModenaItalyCompleted
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyCompleted
Ospedale San Giovanni Bosco
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TurinItalyCompleted
University Hospital Maastricht
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MaastrichtNetherlandsCompleted
Umed Clinical Trials Sp. z o.o.
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LodzPolandCompleted
Uppsala University Hospital
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UppsalaSwedenCompleted

This page is information, not medical advice. Discuss any trial with your doctor.