Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
IRIS
A Multicentre Randomized Double-Blind Placebo Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
2 other identifiers
interventional
359
24 countries
167
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2022
Longer than P75 for phase_3
167 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2021
CompletedFirst Posted
Study publicly available on registry
November 30, 2021
CompletedStudy Start
First participant enrolled
February 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 5, 2028
February 24, 2026
February 1, 2026
5 years
November 17, 2021
February 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in proportion of participants with CRR (Complete Renal Response) in anifrolumab group compared with placebo group
CRR is defined as: * UPCR ≤ 0.5 mg/mg * eGFR ≥ 60 mL/min/1.73 m2 or no decrease from baseline of ≥ 20%
Week 52
Secondary Outcomes (14)
Difference in proportion of participants achieving sustained OCS reduction in anifrolumab group compared with placebo group
from Week 24 through Week 52
HR of achieving sustained CRR in anifrolumab compared with placebo group
baseline through Week 52
Difference in the mean standardized AUC for UPCR between anifrolumab and placebo participants
baseline through Week 52
Difference in proportion of participants with CRR in anifrolumab group compared with placebo group
Week 24
HR to summarize the difference in the risk of hazard of renal-related event or death at any given time between anifrolumab and placebo participants
Through Week 52
- +9 more secondary outcomes
Study Arms (2)
Anifrolumab
EXPERIMENTALSolution for intravenous infusion
Placebo
PLACEBO COMPARATORSolution for intravenous infusion
Interventions
Eligibility Criteria
You may qualify if:
- Active proliferative LN Class III or IV either with or without the presence of Class V according to the 2003 ISN/RPS classification
- Renal biopsy obtained within 6 months prior to signing the ICF or during Screening Period.
- Urine protein to creatinine ratio \> 1 mg/mg (113.17 mg/mmol)
- eGFR ≥ 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula).
- Fulfills updated 2019 EULAR/ACR SLE classification criteria.
- No signs of symptoms of active TB prior to or during screening or no treatment for latent TB
You may not qualify if:
- A diagnosis of pure Class V LN based on the renal biopsy obtained within 6 months prior to signing the ICF or during Screening.
- 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).
- Evidence of hepatitis C or active hepatitis B.
- Any history of cancer except sucessfully cured skin squamos or basal skin carcinoma and cervical cancer in situ.
- 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.
- Previous receipt of \>◦2 investigation treatments (other than anifrolumab) for LN or SLE since time of diagnosis and through the ICF.
- Known intolerance to ≤ 1.0 g/day of MMF.
- Any history of severe COVID-19 infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (167)
Research Site
Glendale, Arizona, 85306, United States
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La Palma, California, 90623, United States
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Los Angeles, California, 90095, United States
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Upland, California, 91786, United States
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Plantation, Florida, 33324, United States
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Atlanta, Georgia, 30308, United States
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Louisville, Kentucky, 40202, United States
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Summit, New Jersey, 07901, United States
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Manhasset, New York, 11030, United States
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New York, New York, 10016, United States
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Winston-Salem, North Carolina, 27157, United States
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Middleburg Heights, Ohio, 44130, United States
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Colleyville, Texas, 76034, United States
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Edinburg, Texas, 78539, United States
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El Paso, Texas, 79902, United States
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Houston, Texas, 77054, United States
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CABA, C1425EOE, Argentina
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Ciudad de Buenos Aires, C1015ABO, Argentina
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La Plata, 1900, Argentina
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Rosario, S2000PBJ, Argentina
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San Juan, 5400, Argentina
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Brussels, 1200, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Belo Horizonte, 30130 100, Brazil
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Campinas, 13087-567, Brazil
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Cuiabá, 78020-500, Brazil
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Maringá, 87060-040, Brazil
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Porto Alegre, 90035-903, Brazil
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Recife, 50740-465, Brazil
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Salvador, 40150-150, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 04014-002, Brazil
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São Paulo, 04036-002, Brazil
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São Paulo, 05403-9000, Brazil
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Plovdiv, 4002, Bulgaria
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Sofia, 1431, Bulgaria
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Beijing, 100034, China
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Beijing, 100044, China
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Bengbu, 233004, China
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Chengdu, 610072, China
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Guangzhou, 510530, China
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Haikou, 570311, China
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Hangzhou, 310009, China
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Jinan, 250021, China
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Jining, 272011, China
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Nanchang, 330006, China
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Nanjing, 210009, China
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Nanjing, 210029, China
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Nanning, 530021, China
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Shanghai, 200025, China
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Shanghai, 200040, China
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Shengyang, 110004, China
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Shenzhen, 518036, China
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Shijiazhuang, 050001, China
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Tianjin, 300201, China
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Wuhan, 430060, China
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Wuxi, 214023, China
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Xi'an, 710061, China
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Zhengzhou, 450000, China
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Barranquilla, 080020, Colombia
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Medellín, 050010, Colombia
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Medellín, 050025, Colombia
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Aurillac, 15002, France
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Bordeaux, 33076, France
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Marseille, 13005, France
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Paris, 75013, France
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Paris, 75018, France
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Paris, 75679, France
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Strasbourg, 67098, France
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Toulouse, 31059, France
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Cologne, 50937, Germany
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Dresden, 1307, Germany
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Hanover, 30625, Germany
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Heidelberg, 69120, Germany
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Kirchheim, 73230, Germany
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Mainz Am Rhein, 55131, Germany
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Budapest, 1085, Hungary
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Budapest, 1097, Hungary
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Debrecen, 4032, Hungary
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Ahmedabad, 380005, India
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Ahmedabad, 382421, India
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Dehradun, 248001, India
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Delhi, 110029, India
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Hyderabad, 500082, India
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Kolkata, 700020, India
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Nadiād, 387001, India
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Pune, 411001, India
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Secunderabad, 500003, India
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Vijayawada, 522002, India
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Visakapatnam, 530013, India
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Ancona, 60126, Italy
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Bologna, 40138, Italy
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Cona, 44124, Italy
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Eboli, 84025, Italy
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Padua, 35128, Italy
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Roma, 00161, Italy
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Bunkyō City, 113-8655, Japan
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Chiba, 260-8712, Japan
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Hiroshima, 734-8551, Japan
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Kita-gun, 761-0793, Japan
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Kitakyushu-shi, 807-8555, Japan
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Matsumoto-shi, 390-8621, Japan
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Nagasaki, 852-8501, Japan
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Okayama, 700-8558, Japan
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Ono, 675-1392, Japan
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Sagamihara-shi, 252-0375, Japan
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Sendai, 980-0872, Japan
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Shinagawa-ku, 142-0054, Japan
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Shinjuku-ku, 160-8582, Japan
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Shinjuku-ku, 162-8655, Japan
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Shinjuku-ku, 162-8666, Japan
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Toyoake-shi, 470-1192, Japan
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Batu Caves, 68100, Malaysia
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Ipoh, 30450, Malaysia
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Kajang, 43000, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuantan, 25100, Malaysia
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Taiping, 34000, Malaysia
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Chihuahua City, 31000, Mexico
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Guadalajara, 44160, Mexico
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Guadalajara, 44650, Mexico
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México, 06726, Mexico
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México, 14080, Mexico
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San Luis Potosí City, 78290, Mexico
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Amsterdam, 1105 AZ, Netherlands
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Lima, 15023, Peru
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Lima, 15046, Peru
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Lima, 15102, Peru
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Lima, L34, Peru
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Lima, LIMA 27, Peru
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Lima, LIMA 29, Peru
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Lodz, 92-213, Poland
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Olsztyn, 10-561, Poland
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Opole, 46-020, Poland
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Poznan, 60-355, Poland
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Poznan, 61-545, Poland
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Rzeszów, 35-301, Poland
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Warsaw, 02-006, Poland
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Caguas, 00725, Puerto Rico
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Moscow, 115522, Russia
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Kaohsiung City, 833, Taiwan
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New Taipei City, 220, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Taipei, 11217, Taiwan
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Taipei, 114, Taiwan
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Taipei, 235, Taiwan
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Bangkok, 10220, Thailand
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Bangkok, 10330, Thailand
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Hat Yai, 90110, Thailand
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Muang, 50200, Thailand
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Ratchathewi, 10400, Thailand
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Adapazarı, 54290, Turkey (Türkiye)
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Ankara, 06100, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Istanbul, 34865, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, 35965, Turkey (Türkiye)
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Kahramanmaraş, 46100, Turkey (Türkiye)
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Kayseri, 38039, Turkey (Türkiye)
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Kocaeli, 41380, Turkey (Türkiye)
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Hanoi, 100000, Vietnam
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Hanoi, 10000, Vietnam
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Hà Nội, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Hochiminh, 70000, Vietnam
Related Publications (1)
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.
PMID: 37528520DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double Blind (Participant, Care Provider and Investigator)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2021
First Posted
November 30, 2021
Study Start
February 15, 2022
Primary Completion (Estimated)
February 26, 2027
Study Completion (Estimated)
December 5, 2028
Last Updated
February 24, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean that all requests will be shared.