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.
- Diseases
- Lupus (SLE), IgA nephropathy
- 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
Sites (31)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Completed |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Luebeck | Germany | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital General Universitario de Ciudad Real Coordinator of this site? Confirm its status | Ciudad Real | Spain | Completed |
| Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Coordinator of this site? Confirm its status | Lleida | Spain | Completed |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| University Hospital Son Espases Coordinator of this site? Confirm its status | Palma | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Universitario Dr. Peset Aleixandre Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Hospital Unviersitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Completed |
| Chu Gabriel Montpied Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Le Kremlin-Bicetre | France | Completed |
| Centre Hospitalier Universitaire de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Completed |
| Hopital Tenon Coordinator of this site? Confirm its status | Paris Cedex 20 | France | Completed |
| Centre Hospitalier Universitaire De Saint Etienne Coordinator of this site? Confirm its status | St Etienne Cedex 2 | France | Completed |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex | France | Completed |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Completed |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Completed |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Completed |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Completed |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Completed |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Completed |
| Ospedale San Giovanni Bosco Coordinator of this site? Confirm its status | Turin | Italy | Completed |
| University Hospital Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Completed |
| Umed Clinical Trials Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.