Could this IV drug tame lupus kidney flares?

NCT ID NCT05138133

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This phase 3 study tests anifrolumab, an IV drug, against placebo in 359 adults with active lupus nephritis (kidney inflammation from lupus). The main goal is to see if more patients achieve complete kidney response, meaning better kidney function and less protein in urine. The trial also looks at reducing steroid use. It is active but not recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: anifrolumab (a drug given by IV infusion)
What this could lead to: If it works, this could offer a new treatment option for lupus nephritis, potentially improving kidney function and reducing the need for steroids.
What could go wrong: This is a phase 3 trial, but results are not yet final. The drug may not prove more effective than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

363 people

The number who actually took part.

Started

Feb 2022

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

lupus nephritis systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lupus nephritis

Contacts and locations

Locations

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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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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Cona, 44124, Italy
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Eboli, 84025, Italy
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Padova, 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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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

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