Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
Launched by ASTRAZENECA · Nov 17, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called Anifrolumab to see how well it works and how safe it is for adults who have a type of kidney inflammation caused by lupus, known as active proliferative lupus nephritis. The trial is currently looking for participants aged 18 and older who have been diagnosed with this condition, which is confirmed by a kidney biopsy within the last six months. To be eligible, participants should also have certain levels of kidney function and protein in their urine.
If you join the trial, you will receive Anifrolumab through an intravenous (IV) infusion, which means the medication will be given directly into your bloodstream. Throughout the study, doctors will monitor your health and any side effects that may occur. It's important to note that some individuals may not qualify for the trial due to specific health issues, such as recent infections or certain other medical conditions. This study aims to provide more information about this treatment option for people living with lupus nephritis.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Active proliferative LN Class III or IV either with or without the presence of Class V according to the 2003 ISN/RPS classification
- • 2. Renal biopsy obtained within 6 months prior to signing the ICF or during Screening Period.
- • 3. Urine protein to creatinine ratio \> 1 mg/mg (113.17 mg/mmol)
- • 4. eGFR ≥ 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula).
- • 5. Fulfills updated 2019 EULAR/ACR SLE classification criteria.
- • 6. No signs of symptoms of active TB prior to or during screening or no treatment for latent TB
- Exclusion Criteria:
- • 1. A diagnosis of pure Class V LN based on the renal biopsy obtained within 6 months prior to signing the ICF or during Screening.
- • 2. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV confirmed by the central lab at Screening - an HIV test must be performed during Screening, and the result should be available prior to Week 0 (Day 1).
- • 3. Evidence of hepatitis C or active hepatitis B.
- • 4. Any history of cancer except sucessfully cured skin squamos or basal skin carcinoma and cervical cancer in situ.
- • 5. Receipt of the following for the current LN flare (ie, since the qualifying renal biopsy): IV cyclophosphamide \> 2 pulses of high-dose (≥ 0.5 g/m2) or \> 4 doses of low dose (500 mg every 2 weeks) or Average MMF \> 2.5 g/day (or \> 1800 mg/day of enteric coated mycophenolate sodium) for more than 8 weeks or Tacrolimus \> 4 mg/day for more than 8 weeks; Cyclosporine for more than 8 weeks or during last 8 weeks prior to signing the ICF; Voclosporin for more than 8 weeks or during last 8 weeks prior to signing the ICF; Belimumab for more than 12 weeks or during last 12 weeks prior the ICF.
- • 6. Previous receipt of \>◦2 investigation treatments (other than anifrolumab) for LN or SLE since time of diagnosis and through the ICF.
- • 7. Known intolerance to ≤ 1.0 g/day of MMF.
- • 8. Any history of severe COVID-19 infection.
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Great Neck, New York, United States
Istanbul, , Turkey
Birmingham, Alabama, United States
New Dehli, , India
Liège, , Belgium
Hyderabad, , India
Pune, , India
Upland, California, United States
Houston, Texas, United States
Summit, New Jersey, United States
El Paso, Texas, United States
Louisville, Kentucky, United States
New York, New York, United States
Las Vegas, Nevada, United States
Leuven, , Belgium
Padova, , Italy
Bordeaux, , France
Toulouse, , France
Hannover, , Germany
Ankara, , Turkey
Orange, California, United States
Debrecen, , Hungary
La Jolla, California, United States
Loma Linda, California, United States
Atlanta, Georgia, United States
Newark, New Jersey, United States
Winston Salem, North Carolina, United States
Plovdiv, , Bulgaria
Heidelberg, , Germany
Stuttgart, , Germany
Budapest, , Hungary
Eboli, , Italy
Roma, , Italy
Glendale, Arizona, United States
Chihuahua, , Mexico
Newark, Delaware, United States
Manhasset, New York, United States
Düsseldorf, , Germany
Köln, , Germany
Brescia, , Italy
Plantation, Florida, United States
Szczecin, , Poland
La Plata, , Argentina
Essen, , Germany
Bordeaux Cedex, , France
New Delhi, , India
Olsztyn, , Poland
Hallandale Beach, Florida, United States
Shanghai, , China
München, , Germany
Taichung, , Taiwan
Mexico, , Mexico
Bologna, , Italy
Bruxelles, , Belgium
Cona, , Italy
Chiba Shi, , Japan
Fukuoka Shi, , Japan
Kitakyushu Shi, , Japan
Shinjuku Ku, , Japan
Danville, Pennsylvania, United States
Colleyville, Texas, United States
Chuo Ku, , Japan
Taipei, , Taiwan
Amsterdam, , Netherlands
Beijing, , China
Guangzhou, , China
Hangzhou, , China
Nanning, , China
Pécs, , Hungary
Batu Caves, , Malaysia
Kuala Lumpur, , Malaysia
Taiping, , Malaysia
Krasnoyarsk, , Russian Federation
Paris, , France
Ancona, , Italy
New Haven, Connecticut, United States
Marseille, , France
Xi'an, , China
Moscow, , Russian Federation
Phoenix, Arizona, United States
Las Cruces, New Mexico, United States
Edinburg, Texas, United States
Caguas, , Puerto Rico
San Juan, , Puerto Rico
Monza, , Italy
Nanchang, , China
Bunkyo Ku, , Japan
Guadalajara, , Mexico
Ratchathewi, , Thailand
Istanbul, , Turkey
Hanoi, , Vietnam
Wuxi, , China
Ho Chi Minh, , Vietnam
La Palma, California, United States
Nadarzyn, , Poland
Kocaeli, , Turkey
Warszawa, , Poland
Strasbourg Cedex, , France
Poznań, , Poland
Jinan, , China
Jining, , China
Nanjing, , China
Shenzhen, , China
Wiesbaden, , Germany
Middleburg Heights, Ohio, United States
Bengbu, , China
Sapporo Shi, , Japan
Taoyuan, , Taiwan
Osaka Shi, , Japan
New Taipei City, , Taiwan
Hat Yai, , Thailand
Hochiminh, , Vietnam
Kayseri, , Turkey
Mainz Am Rhein, , Germany
San Juan, , Argentina
Muang, , Thailand
Dresden, , Germany
Sagamihara Shi, , Japan
Izumo Shi, , Japan
Hiroshima Shi, , Japan
Haikou, , China
Shanghai, , China
Ha Noi, , Vietnam
Vijayawada, , India
México, , Mexico
Bellavista, , Peru
Nadiad, , India
łódź, , Poland
Aurillac Cedex, , France
Nagasaki Shi, , Japan
Barranquilla, , Colombia
Kuantan, , Malaysia
Kaohsiung, , Taiwan
Shengyang, , China
Matsumoto Shi, , Japan
Okayama, , Japan
Orenburg, , Russian Federation
Buenos Aires, , Argentina
Sao Paulo, , Brazil
Cordoba, , Argentina
Salvador, , Brazil
Kirchheim, , Germany
Lima, , Peru
Porto Alegre, , Brazil
Opole, , Poland
Kita Gun, , Japan
Sofia, , Bulgaria
Rosario, , Argentina
Toyoake Shi, , Japan
Zhengzhou City, , China
Chengdu, , China
Wuhan, , China
Kolkata, , India
Saint Louis, Missouri, United States
Allen, Texas, United States
Dehradun, , India
Bangkok, , Thailand
Adapazari, , Turkey
Wrocław, , Poland
Secunderabad, , India
Taipei City, , Taiwan
Sendai Shi, , Japan
Shijiazhuang, , China
Sao Jose Do Rio Preto, , Brazil
Goettingen, , Germany
Piura, , Peru
Maringá, , Brazil
Gurugram, , India
Medellin, , Colombia
Bydgoszcz, , Poland
Rome, , Italy
Chelyabinsk, , Russian Federation
Kahramanmaras, , Turkey
Tianjin, , China
Sun City Center, Florida, United States
San Miguel De Tucuman, , Argentina
Ahmedabad, , India
Shinagawa Ku, , Japan
San Luis Potosi, , Mexico
Poznań, , Poland
Novosibirsk, , Russian Federation
St. Petersburg, , Russian Federation
Delhi, , India
Jodhpur, , India
Ono, , Japan
Gifu Shi, , Japan
Kajang, , Malaysia
Ahmedabad, , India
Caba, , Argentina
Visakapatnam, , India
Izmir, , Turkey
Cali, , Colombia
Recife, , Brazil
Medellín, , Colombia
Rzeszów, , Poland
Belo Horizonte, , Brazil
São Paulo, , Brazil
Medellin, , Colombia
Ipoh, , Malaysia
Bengbu, , China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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