Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

Last updated: January 20, 2026
Sponsor: Alexion Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Proteinuria

Glomerulonephritis

Treatment

Placebo

Ravulizumab

Clinical Study ID

NCT06291376
D928FC00001
  • Ages > 18
  • All Genders

Study Summary

The primary objective of this study to evaluate efficacy of ravulizumab compared with placebo on proteinuria reduction and change in eGFR in adult participants with IgAN who are at risk of disease progression.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documentation of IgAN diagnosis established on kidney biopsy obtained any time priorto or during the Screening Period for participants with eGFR ≥ 30 mL/min/1.73 m^2.

  • For participants in the AdKD cohorts, eGFR 20 to 29 mL/min/1.73 m2 a kidney biopsyis required within 6 months prior to Screening or during the Screening Period.

  • UPCR ≥ 0.75 g/g or UP ≥1 g/day calculated from the mean of two 24-hour urine duringthe Screening Period.

  • Estimated GFR ≥ 30 mL/min/1.73 m2 at Screening.

  • Stable and maximum allowed or tolerated RASI (ACEI and/or ARB) dose for ≥ 3 monthsprior to Screening with no planned change during Screening through Week 106.

  • Participants who are receiving SGLT2I, DEARA, MRA or ERA must be on a stable andmaximum allowed or tolerated dose for ≥ 3 months prior to Screening with no plannedchange in dose through Week 106.

Exclusion

Exclusion Criteria:

  • Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss ≥ 50%over a period of 3 months prior to Screening.

  • Secondary IgAN (eg, due to systemic lupus erythematosus (SLE), cirrhosis, or celiacdisease; IgAV-N may be eligible).

  • Concomitant clinically significant renal disease other than IgAN.

  • Prior use of immunosuppressive treatment within 3 months of screening.

  • Uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8.5%.

  • Henoch-Schonlein purpura (IgAV) requiring systemic immunosuppressive therapy within 12 months of Screening.

  • History of kidney transplant or planned kidney transplant during the TreatmentPeriod.

  • Splenectomy or functional asplenia.

  • History of Neisseria meningitidis infection.

  • Active systemic bacterial, viral, or fungal infection within 14 days prior torandomization.

Study Design

Total Participants: 510
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
March 29, 2024
Estimated Completion Date:
July 19, 2030

Study Description

The I CAN study will enroll approximately 510 eligible participants with IgAN who are high risk of disease progression. Participants will be on stable concomitant IgAN treatment(s) consistent with standard of care for patients with IgAN for at least 3 months prior to Screening. Approximately 450 participants will be randomized in a 1:1 allocation ratio to receive a weight-based IV infusion of either ravulizumab or placebo. An interim analysis may be conducted at Week 34 to evaluate change in proteinuria and the final analysis will be conducted at Week 106 to evaluate eGFR. In addition, approximately 60 participants with eGFR 20-29 mL/min/1.73m2 will be enrolled in an Advanced Kidney Disease (AdKD) Cohort After Week 106, all participants have the option to enter an Open-label Ravulizumab Access Period.

Connect with a study center

  • Research Site

    Buenos Aires, C1425AGC
    Argentina

    Site Not Available

  • Research Site

    Buenos Aires 3435910, C1425AGC
    Argentina

    Site Not Available

  • Research Site

    Ciudad Autonoma Bs As, C1015ABO
    Argentina

    Site Not Available

  • Research Site

    Ciudad de Buenos Aires, C1425AGC
    Argentina

    Active - Recruiting

  • Research Site

    Cordoba, X5016KET
    Argentina

    Site Not Available

  • Research Site

    Córdoba, X5016KET
    Argentina

    Site Not Available

  • Research Site

    Córdoba 3860259, X5016KET
    Argentina

    Active - Recruiting

  • Research Site

    Florencio Varela, 1888
    Argentina

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  • Research Site

    La Plata, B1902COS
    Argentina

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  • Research Site

    La Plata 3432043, B1902COS
    Argentina

    Active - Recruiting

  • Research Site

    Rosario, 2000
    Argentina

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  • Research Site

    Rosario 3838583, 2000
    Argentina

    Active - Recruiting

  • Research Site

    San Juan Bautista 3433923, 1888
    Argentina

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  • Research Site

    San Luis, D5700
    Argentina

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    San Luis 3837056, D5700
    Argentina

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    Camperdown, 2050
    Australia

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    Camperdown 2172563, 2050
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    Canberra, 2605
    Australia

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    Canberra 2172517, 2605
    Australia

    Active - Recruiting

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    Clayton, 3168
    Australia

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    Clayton 2171400, 3168
    Australia

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  • Research Site

    Concord, 2139
    Australia

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    Concord 2170852, 2139
    Australia

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    Herston, 4029
    Australia

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    Herston 6931014, 4029
    Australia

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    Liverpool, 2170
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    Liverpool 2159851, 2170
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    Parkville, 3050
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    Parkville 2153770, 3050
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    Perth, 6000
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    Perth 2063523, 6000
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    Southport, 4222
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    Southport 2148928, 4222
    Australia

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    St Albans, 3021
    Australia

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    St Albans 8015209, 3021
    Australia

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    Graz, 8036
    Austria

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    Graz 2778067, 8036
    Austria

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    Innsbruck, 6020
    Austria

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    Innsbruck 2775220, 6020
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    Linz, 4020
    Austria

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    Linz 2772400, 4020
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    Brussel, 1090
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    Brussels, 1090
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    Brussels 2800866, 1090
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    Edegem, 2650
    Belgium

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    Edegem 2799007, 2650
    Belgium

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    Leuven, 3000
    Belgium

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    Leuven 2792482, 3000
    Belgium

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    Liège, 4000
    Belgium

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    Liège 2792413, 4000
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    Roeselare, 8800
    Belgium

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    Roeselare 2787889, 8800
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    Belo Horizonte, 30110-934
    Brazil

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    Belo Horizonte 3470127, 30150-221
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    Botucatu, 18618-687
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    Botucatu 3469136, 18618-687
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    Curitiba, 80440-020
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    Curitiba 3464975, 80440-020
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    Fortaleza, 60430-270
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    Fortaleza 3399415, 60430-270
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    Recife, 50670-901
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    Recife 3390760, 50670-901
    Brazil

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    Ribeirão Preto, 14051-140
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    Ribeirão Preto 3451328, 14051-140
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    S.J. Do Rio Preto, 15090-000
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    Salvador, 40170-130
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    Salvador 3450554, 40170-130
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    São José do Rio Preto, 15090-000
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    São José do Rio Preto 3448639, 15090-000
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    São Paulo, 05403-000
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    São Paulo 3448439, 05403-000
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    Winnipeg, Manitoba R2V 3M3
    Canada

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    Winnipeg 6183235, Manitoba 6065171 R2V 3M3
    Canada

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    London, Ontario N6A 5W9
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    Ottawa, Ontario K1H 7W9
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    Toronto, Ontario M5G 2C4
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    Brampton 5907364, Ontario 6093943 L6T 5T6
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    London 6058560, Ontario 6093943 N6A 5W9
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    Ottawa 6094817, Ontario 6093943 K1H 7W9
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    Toronto 6167865, Ontario 6093943 M5G 2C4
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    Araucania, 4781151
    Chile

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    Providencia, 7500000
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    Providencia 3875139, 7500000
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    Santiago, 7500922
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    Santiago 3871336, 8330034
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    Valdivia, 5090146
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    Valdivia 3868707, 5090146
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    Baotou, 14010
    China

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    Baotou 2038432, 14010
    China

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    Beijing, 100044
    China

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    Beijing 1816670, 100029
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    Changsha, 410013
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    Changsha 1815577, 410013
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    Changzhou, 272100
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    Changzhou 1815456, 272100
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    Chengdu, 610000
    China

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    Chengdu 1815286, 610072
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    Chongqing, 400010
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    Chongqing 1814906, 400010
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    Guangzhou, 510080
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    Guangzhou 1809858, 510080
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    Hangzhou, 310009
    China

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    Hangzhou 1808926, 310003
    China

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    Jinan, 250021
    China

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    Jinan 1805753, 250012
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    Jinhua,
    China

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    Jinhua 1805528,
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    Lanzhou, 730000
    China

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    Lanzhou 1804430, 730000
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    Luoyang, 471000
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    Luoyang 1801792, 471000
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    Nanchang, 330008
    China

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    Nanchang 1800163, 330008
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    Nanjing, 210029
    China

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    Nanjing 1799962, 210029
    China

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    Ningbo, 315010
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    Ningbo 1799397, 315010
    China

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    Qingdao, 110016
    China

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    Qingdao 1797929, 110016
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    Shanghai, 200025
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    Shanghai 1796236, 200040
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    Shenyang, 110001
    China

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    Shenyang 2034937, 110001
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    Shenzhen, 518036
    China

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    Shenzhen 1795565, 518036
    China

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    Urumqi, 831118
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    Wuhan, 430060
    China

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    Wuhan 1791247, 430060
    China

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    Wuxi, 214023
    China

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    Wuxi 1790923, 214023
    China

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    Xi'an 1790630, 710061
    China

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    Xian, 710061
    China

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    Yantai, 264000
    China

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    Yantai 1787093, 264000
    China

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  • Research Site

    Yibin, 610500
    China

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  • Research Site

    Yibin 1786770, 610500
    China

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    Yinchuan, 750004
    China

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    Yinchuan 1786657, 750004
    China

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    Zhanjiang, 524001
    China

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    Zhanjiang 1784990, 524001
    China

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  • Research Site

    Zhengzhou, 450052
    China

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    Zhengzhou 1784658, 450052
    China

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    Zhongshan, 528401
    China

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  • Research Site

    Zhongshan 6986104, 528401
    China

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  • Research Site

    Ürümqi 1529102, 831118
    China

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  • Research Site

    Barranquilla, 080020
    Colombia

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  • Research Site

    Barranquilla 3689147, 080020
    Colombia

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  • Research Site

    Bogota, 111411
    Colombia

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  • Research Site

    Bogotá 3688689, 111411
    Colombia

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  • Research Site

    Cali, 760032
    Colombia

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    Cali 3687925, 760032
    Colombia

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    Manizales, 17001
    Colombia

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    Manizales 3675443, 17001
    Colombia

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    Medellín, 050010
    Colombia

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    Medellín 3674962, 050010
    Colombia

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    Rionegro, 054047
    Colombia

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    Rionegro 3670730, 054047
    Colombia

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    Santiago de Cali 3687925, 760032
    Colombia

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  • Research Site

    Nový Jičín, 741 01
    Czechia

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    Nový Jičín 3069305, 741 01
    Czechia

    Active - Recruiting

  • Research Site

    Prague 3067696, 140 00
    Czechia

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    Praha, 140 00
    Czechia

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    Praha 2, 128 00
    Czechia

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    Praha 4, 140 00
    Czechia

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  • Research Site

    Amiens, 80054
    France

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  • Research Site

    Amiens 3037854, 80054
    France

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    Amiens Cedex 1, 80054
    France

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    Bayonne, 64100
    France

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    Bayonne 3034475, 64100
    France

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    Brest 3030300, 29200
    France

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    Brest Cedex, 29200
    France

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    Chambéry, 73011
    France

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    Chambéry 3027422, 73011
    France

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    Chambéry Cedex, 73011
    France

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    Clermont Ferrand, 63003
    France

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    Clermont-Ferrand, 63003
    France

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    Clermont-Ferrand 3024635, 63003
    France

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    Le Kremlin-Bicêtre, 94270
    France

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  • Research Site

    Le Kremlin-Bicêtre 3003737, 94270
    France

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    Marseille, 13385
    France

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    Marseille 2995469, 13385
    France

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    Nantes, 44093
    France

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    Nantes 2990969, 44093
    France

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    Nice, 06000
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    Nice 2990440, 06000
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    Nice cedex 1, 06002
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    Paris, 75010
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    Paris 2988507, 75020
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    Saint-Priest-en-Jarez, 42270
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    Saint-Priest-en-Jarez 2977350, 42270
    France

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    Sr Priest En Jarez, 42270
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    Strasbourg, 67091
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    Strasbourg 2973783, 67091
    France

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    Toulouse, 31059
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    Toulouse 2972315, 31059
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    Aachen, 52074
    Germany

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    Aachen 3247449, 52074
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    Berlin, 10117
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    Berlin 2950159, 10117
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    Cologne 2886242, 50937
    Germany

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    Erlangen, 91054
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    Erlangen 2929567, 91054
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    Essen, 45122
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    Essen 2928810, 45122
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    Greifswald, 17475
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    Greifswald 2917788, 17475
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    Hannover, 30625
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    Hanover 2910831, 30625
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    Konstanz, 78464
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    Konstanz 2885679, 78464
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    Köln, 50937
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    Mainz, 55131
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    Mainz 2874225, 55131
    Germany

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    München, 81657
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    München 2867711, 81657
    Germany

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    Villingen-Schwenningen, 78052
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    Villingen-Schwenningen 2817220, 78052
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    Athens, 11527
    Greece

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    Athens 264371, 11527
    Greece

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    Heraclion, 71500
    Greece

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    Heraklion 261745, 71500
    Greece

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    Patras, 26504
    Greece

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    Pátrai 255683, 26504
    Greece

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    Thessaloniki, 57010
    Greece

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    Thessaloniki 734077, 57010
    Greece

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    HKG,
    Hong Kong

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    Hong Kong, 999077
    Hong Kong

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    Hong Kong 1819729,
    Hong Kong

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    Lai Chi Kok,
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    Lai Chi Kok 1819567,
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    Shatin, 00000
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    Budapest, 1085
    Hungary

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    Budapest 3054643, 1085
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    Miskolc, 3526
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    Miskolc 717582, 3526
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    Haifa, 3109601
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    Haifa 294801, 3109601
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    Jerusalem, 91120
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    Jerusalem 281184, 91120
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    Nazareth, 16100
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    Nazareth 294098, 16100
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    Petah Tikva, 49372
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    Petah Tikva 293918, 49372
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    Tel Aviv, 6423906
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    Tel Aviv 293397, 6423906
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    Agrigento, 92100
    Italy

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    Agrigento 2525764, 92100
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    Bari, 70124
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    Bologna, 40138
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    Bologna 3181928, 40138
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    Cagliari, 09121
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    Cagliari 2525473, 09121
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    Firenze, 50134
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    Site Not Available

  • Research Site

    North Las Vegas 5509403, Nevada 5509151 89086
    United States

    Active - Recruiting

  • Research Site

    Albany, New York 12208
    United States

    Site Not Available

  • Research Site

    Bronx, New York 10468
    United States

    Site Not Available

  • Research Site

    East Setauket, New York 11733
    United States

    Site Not Available

  • Research Site

    New York, New York 10016
    United States

    Site Not Available

  • Research Site

    Albany 5106834, New York 5128638 12208
    United States

    Active - Recruiting

  • Research Site

    East Setauket 5116060, New York 5128638 11733
    United States

    Active - Recruiting

  • Research Site

    New York 5128581, New York 5128638 10016
    United States

    Active - Recruiting

  • Research Site

    The Bronx 5110266, New York 5128638 10468
    United States

    Active - Recruiting

  • Research Site

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Research Site

    Columbus 4509177, Ohio 5165418 43210
    United States

    Active - Recruiting

  • Research Site

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Research Site

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Active - Recruiting

  • Research Site

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Research Site

    Knoxville 4634946, Tennessee 4662168 37920
    United States

    Active - Recruiting

  • Research Site

    Arlington, Texas 76002
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Research Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Research Site

    Shenandoah, Texas 77384
    United States

    Site Not Available

  • Research Site

    Temple, Texas 76508
    United States

    Site Not Available

  • Research Site

    Arlington 4671240, Texas 4736286 76002
    United States

    Active - Recruiting

  • Research Site

    Houston 4699066, Texas 4736286 77054
    United States

    Active - Recruiting

  • Research Site

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • Research Site

    Shenandoah 4728287, Texas 4736286 77384
    United States

    Active - Recruiting

  • Research Site

    Temple 4735966, Texas 4736286 76508
    United States

    Site Not Available

  • Research Site

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Research Site

    Charlottesville 4752031, Virginia 6254928 22903
    United States

    Active - Recruiting

  • Research Site

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Research Site

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Active - Recruiting

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