Lupus Nephritis Clinical Trial
— SANCTUARYOfficial title:
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)
The objectives of this study are to evaluate the safety and efficacy of ravulizumab administered by intravenous (IV) infusion compared to placebo and demonstrate proof-of-concept of the efficacy of terminal complement inhibition in participants with LN (LN Cohort) or IgAN (IgAN Cohort).
Status | Recruiting |
Enrollment | 120 |
Est. completion date | October 31, 2026 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: Common to both disease cohorts: - 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: Common to both disease cohorts: - 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Clinical Study Site | Herston | Queensland |
Australia | Clinical Study Site | Parkville | Melbourne |
Australia | Clinical Study Site | Westmead | New South Wales |
Canada | Clinical Study Site | London | Ontario |
Canada | Clinical Study Site | Montreal | Quebec |
Canada | Clinical Study Site | Quebec | |
France | Clinical Study Site | Clermont-Ferrand | |
France | Clinical Study Site | Créteil | |
France | Clinical Study Site | Le Kremlin-Bicêtre | |
France | Clinical Study Site | Montpellier | |
France | Clinical Study Site | Paris | |
France | Clinical Study Site | Saint-Étienne | |
France | Clinical Study Site | Strasbourg | Bas-Rhin |
France | Clinical Study Site | Toulouse | |
Germany | Clinical Study Site | Berlin | |
Germany | Clinical Study Site | Essen | |
Germany | Clinical Study Site | Essen | North Rhine-Westphalia |
Germany | Clinical Study Site | Hannover | Niedersachsen |
Germany | Clinical Study Site | Lubeck | |
Italy | Clinical Study Site | Bergamo | |
Italy | Clinical Study Site | Bologna | |
Italy | Clinical Study Site | Brescia | |
Italy | Clinical Study Site | Firenze | |
Italy | Clinical Study Site | Monza | |
Italy | Clinical Study Site | Torino | |
Korea, Republic of | Clinical Study Site | Anyang-si | Gyeonggi-do |
Korea, Republic of | Clinical Study Site | Seongnam | Gyeonggi-do |
Korea, Republic of | Clinical Study Site | Seoul | |
Korea, Republic of | Clinical Study Site | Seoul | |
Korea, Republic of | Clinical Study Site | Seoul | |
Korea, Republic of | Clinical Study Site | Seoul | |
Netherlands | Clinical Study Site | Maastricht | |
Poland | Clinical Study Site | Bydgoszcz | |
Poland | Clinical Study Site | Lodz | |
Singapore | Clinical Study Site | Singapore | |
Spain | Clinical Study Site | Alicante | |
Spain | Clinical Study Site | Barcelona | |
Spain | Clinical Study Site | Barcelona | |
Spain | Clinical Study Site | Lleida | |
Spain | Clinical Study Site | Madrid | |
Spain | Clinical Study Site | Madrid | |
Spain | Clinical Study Site | Madrid | |
Spain | Clinical Study Site | Malaga | |
Spain | Clinical Study Site | Palma | Illes Balears |
Spain | Clinical Study Site | Santiago De Compostela | A Coruña |
Spain | Clinical Study Site | Sevilla | Andalucia |
Spain | Clinical Study Site | Valencia | Comunidad |
Spain | Clinical Study Site | Zaragoza | |
Sweden | Clinical Study Site | Orebro | |
Sweden | Clinical Study Site | Uppsala | |
Taiwan | Clinical Study Site | Kaohsiung City | |
Taiwan | Clinical Study Site | Kaohsiung City | |
Taiwan | Clinical Study Site | New Taipei City | |
Taiwan | Clinical Study Site | Taichung City | |
United Kingdom | Clinical Study Site | Birmingham | |
United Kingdom | Clinical Study Site | London | |
United Kingdom | Clinical Study Site | London | |
United Kingdom | Clinical Study Site | Nottingham | |
United Kingdom | Clinical Study Site | Salford | |
United States | Clinical Study Site | Boston | Massachusetts |
United States | Clinical Study Site | Boston | Massachusetts |
United States | Clinical Study Site | Chapel Hill | North Carolina |
United States | Clinical Study Site | Columbus | Ohio |
United States | Clinical Study Site | Dallas | Texas |
United States | Clinical Study Site | El Paso | Texas |
United States | Clinical Study Site | Fort Worth | Texas |
United States | Clinical Study Site | Hollywood | Florida |
United States | Clinical Study Site | Houston | Texas |
United States | Clinical Study Site | Houston | Texas |
United States | Clinical Study Site | Kansas City | Missouri |
United States | Clinical Study Site | Lawrenceville | Georgia |
United States | Clinical Study Site | Lexington | Kentucky |
United States | Clinical Study Site | Los Angeles | California |
United States | Clinical Study Site | Louisville | Kentucky |
United States | Clinical Study Site | Milwaukee | Wisconsin |
United States | Clinical Study Site | New York | New York |
United States | Clinical Study Site | Orlando | Florida |
United States | Clinical Study Site | S. Gate | California |
United States | Clinical Study Site | Salt Lake City | Utah |
United States | Clinical Study Site | San Dimas | California |
United States | Clinical Study Site | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Alexion Pharmaceuticals, Inc. |
United States, Australia, Canada, France, Germany, Italy, Korea, Republic of, Netherlands, Poland, Singapore, Spain, Sweden, Taiwan, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Both Cohorts: Percentage Change In Proteinuria From Baseline To Week 26 Assessed Using 24-hour Urine Collections | Baseline, Week 26 | ||
Secondary | Both Cohorts: Percentage Change In Proteinuria From Baseline To Week 50 Assessed Using 24-hour Urine Collections | Baseline, Week 50 | ||
Secondary | Both Cohorts: Change In Estimated Glomerular Filtration Rate (eGFR) From Baseline At Week 26 And Week 50 | Baseline, Week 26, Week 50 | ||
Secondary | LN Cohort: Percentage Of Participants Meeting The Criteria For Complete Renal Response | Complete renal response will be determined by assessing proteinuria on 24-hour urine collections, eGFR levels, and no treatment failure. | Week 26 and Week 50 | |
Secondary | LN Cohort: Percentage Of Participants Meeting The Criteria For Partial Renal Response | Partial renal response will be determined by assessing proteinuria on 24-hour urine collections, eGFR levels, and no treatment failure. | Week 26 and Week 50 | |
Secondary | LN Cohort: Time To Urine Protein To Creatinine Ratio < 0.5 g/g | Baseline through Week 50 | ||
Secondary | LN Cohort: Percentage Of Participants Achieving Corticosteroid Taper To 7.5 mg/day | Week 14, Week 26, and Week 50 | ||
Secondary | LN Cohort: Percentage Of Participants With Renal Flare | Baseline through Week 50 | ||
Secondary | LN Cohort: Percentage Of Participants With Extrarenal Systemic Lupus Erythematosus Flare | Baseline through Week 50 | ||
Secondary | IgAN Cohort: Percentage Of Participants Meeting The Criteria For Partial Remission | Partial remission will be determined by assessing proteinuria on 24-hour urine collections. | Week 26 and Week 50 |
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