Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V

Last updated: March 18, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

Lupus Nephritis

Cutaneous Lupus Erythematosus

Systemic Lupus Erythematosus

Treatment

Placebo + standard of care

Iptacopan (part 1)

Iptacopan (part 2)

Clinical Study ID

NCT05268289
CLNP023K12201
2021-002046-33
  • Ages 18-100
  • All Genders

Study Summary

The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Unequivocally positive ANA test result and/or a positive anti dsDNA at screening Active biopsy-proven lupus nephritis within 3 months of screening demonstrating Class III or IV lupus nephritis with or without co-existing features of Class V lupus nephritis.

Documentation of active renal disease at the time of screening necessitating the commencement of therapy with corticosteroids in combination with MMF/MPS.

eGFR ≥ 30 ml/min/1.73 m2 Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infections Vaccination against Haemophilus influenzae infection Supportive care including stable dose regimen of anti-malarials (e.g. hydroxychloroquine) unless contraindicated, ACEi or ARB at either locally approved maximal daily dose or the maximally tolerated dose (per investigators' judgement) at screening, as per the local clinical practice. Doses should remain stable throughout the study.

First presentation or flare of lupus nephritis.

Exclusion

Exclusion Criteria:

Induction treatment with cyclophosphamide within 3 months of planned treatment for this study; treatment with calcineurin inhibitors within the previous 3 months prior to randomization.

Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to screening.

Renal biopsy presenting with interstitial fibrosis/tubular atrophy (IF/TA) or glomerulosclerosis of more than 50%, or which in the opinion of the investigator is such that it precludes likely response to immunosuppressive therapy.

Participants being treated with systemic corticosteroids (>5 mg/day prednisone or equivalent) for indications other than SLE or LN e.g. acute asthma, inflammatory bowel disease.

Participants being treated with systemic corticosteroids for SLE or LN will be excluded if they have taken more than an average of 15 mg/day prednisone (or equivalent) in the previous 4 weeks and more than an average of 30 mg/day in the previous 1 week Receipt of more than a total dose of 1000 mg equivalent i.v. pulse methylprednisolone (cumulative dose) within 2 weeks prior to enrollment (and at enrollment)

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Total Participants: 240
Treatment Group(s): 4
Primary Treatment: Placebo + standard of care
Phase: 2
Study Start date:
August 10, 2022
Estimated Completion Date:
September 28, 2028

Study Description

The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.

Connect with a study center

  • Novartis Investigative Site

    Rosario, Santa Fe Province 2000
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Rosario 3838583, Santa Fe Province 3836276 2000
    Argentina

    Site Not Available

  • Novartis Investigative Site

    San Luis, 5700
    Argentina

    Site Not Available

  • Novartis Investigative Site

    San Luis 3837056, 5700
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Santa Fe, S3000EPV
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Santa Fe 3836277, S3000EPV
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais 30150-221
    Brazil

    Completed

  • Novartis Investigative Site

    Juiz de Fora, Minas Gerais 36010 570
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Belo Horizonte 3470127, Minas Gerais 3457153 30150-221
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Juiz de Fora 3459505, Minas Gerais 3457153 36010 570
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Sao Paulo, SP 01308-050
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Barretos, São Paulo 14784 400
    Brazil

    Site Not Available

  • Novartis Investigative Site

    São Paulo, São Paulo 01308-050
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Barretos 3470451, São Paulo 3448433 14784 400
    Brazil

    Site Not Available

  • Novartis Investigative Site

    São Paulo 3448439, São Paulo 3448433 04038-002
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Salvador, 40323-010
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Salvador 3450554, 40323-010
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Nanning, Guangxi 530022
    China

    Active - Recruiting

  • Novartis Investigative Site

    Nanning 1799869, Guangxi 1809867 530022
    China

    Site Not Available

  • Novartis Investigative Site

    Wuhan, Hubei 430022
    China

    Active - Recruiting

  • Novartis Investigative Site

    Wuhan 1791247, Hubei 1806949 430022
    China

    Site Not Available

  • Novartis Investigative Site

    Shenyang, Liaoning 110004
    China

    Active - Recruiting

  • Novartis Investigative Site

    Shenyang 2034937, Liaoning 2036115 110004
    China

    Site Not Available

  • Novartis Investigative Site

    Yinchuan, Ningxia 750004
    China

    Site Not Available

  • Novartis Investigative Site

    Yinchuan 1786657, Ningxia 1799355 750004
    China

    Site Not Available

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    Beijing, 100034
    China

    Site Not Available

  • Novartis Investigative Site

    Beijing 1816670, 100034
    China

    Site Not Available

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    Shenzhen, 518036
    China

    Active - Recruiting

  • Novartis Investigative Site

    Shenzhen 1795565, 518036
    China

    Site Not Available

  • Novartis Investigative Site

    Barranquilla, Atlántico 080020
    Colombia

    Site Not Available

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    Barranquilla 3689147, Atlántico 3689436 080020
    Colombia

    Site Not Available

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    Bogota, Cundinamarca 111411
    Colombia

    Site Not Available

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    Bucaramanga, Santander Department 680003
    Colombia

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    Bucaramanga 3688465, Santander Department 3668578 680003
    Colombia

    Site Not Available

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    Monteria, 230004
    Colombia

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    Montería, 230004
    Colombia

    Site Not Available

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    Montería 3674453, 230004
    Colombia

    Site Not Available

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    Marseille, 13005
    France

    Completed

  • Novartis Investigative Site

    Marseille 2995469, 13005
    France

    Site Not Available

  • Novartis Investigative Site

    Nantes, 44093
    France

    Active - Recruiting

  • Novartis Investigative Site

    Nantes 2990969, 44093
    France

    Site Not Available

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    Nantes Cedex 1, 44093
    France

    Site Not Available

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    Paris, 75015
    France

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    Paris 2988507, 75015
    France

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    Strasbourg, 67091
    France

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    Strasbourg 2973783, 67091
    France

    Site Not Available

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    Strasbourg Cedex, 67091
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    Munich, Bavaria 81377
    Germany

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    Munich 2867714, Bavaria 2951839 81377
    Germany

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    Ludwigshafen, Germany 67063
    Germany

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    Ludwigshafen 2875377, Germany 67063
    Germany

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    Frankfurt am Main, Hesse 60590
    Germany

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    Frankfurt am Main 2925533, Hesse 2905330 60590
    Germany

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    Braunschweig, Lower Saxony 38126
    Germany

    Active - Recruiting

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    Braunschweig 2945024, Lower Saxony 2862926 38126
    Germany

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    Koeln, Nordrhein-Westfalen 51109
    Germany

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    Cologne, North Rhine-Westphalia 51109
    Germany

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    Cologne 2886242, North Rhine-Westphalia 2861876 51109
    Germany

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    Berlin, 13353
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    Berlin 2950159, 13353
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    Frankfurt, 60590
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    Mainz, 55131
    Germany

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    Mainz 2874225, 55131
    Germany

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    Muenchen, 81377
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    Hong Kong, Hong Kong 999077
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    Hong Kong 1819729, Hong Kong 999077
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    Pokfulam, 999077
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    Debrecen, Hajdu Bihar Megye 4032
    Hungary

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    Debrecen 721472, Hajdu Bihar Megye 4032
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    Budapest 3054643, H-1083
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    Szeged, 6725
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    Szeged 715429, 6725
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    Ahmedabad, Gujarat 380015
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    Ahmedabad 1279233, Gujarat 1270770 380015
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    Kozhikode, Kerala 673008
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    Kozhikode 1265873, Kerala 1267254 673008
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    New Delhi, National Capital Territory of Delhi 110029
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    New Delhi 1261481, National Capital Territory of Delhi 1273293 110029
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    Vellore, Tamil Nadu 632 004
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    Vellore 1253286, Tamil Nadu 1255053 632 004
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    Hyderabad, Telangana 500082
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    Hyderabad 1269843, Telangana 1254788 500082
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    Lucknow, Uttar Pradesh 226014
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    Lucknow 1264733, Uttar Pradesh 1253626 226014
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    Puducherry, 607402
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    Puducherry 1259425, 607402
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    Ashkelon, 7830604
    Israel

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    Ashkelon 295620, 7830604
    Israel

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    Jerusalem, 9112001
    Israel

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    Jerusalem 281184, 9112001
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    Ramat Gan, 5265601
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  • Novartis Investigative Site

    Ramat Gan 293788, 5265601
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  • Novartis Investigative Site

    Kuantan, Pahang 25100
    Malaysia

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  • Novartis Investigative Site

    Kuantan 1735227, Pahang 1733042 25100
    Malaysia

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    Taiping, Perak 34000
    Malaysia

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    Taiping 1734586, Perak 1733041 34000
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    Selangor Darul Ehsan, 68100
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  • Novartis Investigative Site

    Tampico, Tamaulipas 89440
    Mexico

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    Tampico 3516355, Tamaulipas 3516391 89440
    Mexico

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    Merida, Yucatan 97070
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    Mérida, Yucatán 97070
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    Mérida 3523349, Yucatán 3514211 97070
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    Aguascalientes, 20230
    Mexico

    Completed

  • Novartis Investigative Site

    Aguascalientes 4019233, 20230
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    Veracruz, 91900
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    Veracruz 3514783, 91900
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  • Novartis Investigative Site

    Makati, Metro Manila 1218
    Philippines

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  • Novartis Investigative Site

    Makati City, National Capital Region 1218
    Philippines

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  • Novartis Investigative Site

    Makati City 1703417, National Capital Region 7521311 1218
    Philippines

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  • Novartis Investigative Site

    Iloilo, 5000
    Philippines

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    Iloilo City, 5000
    Philippines

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    Iloilo City 1711005, 5000
    Philippines

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    Quezon, 1102
    Philippines

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  • Novartis Investigative Site

    Quezon 1692214, 1102
    Philippines

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  • Novartis Investigative Site

    Carnaxide - Linda-A-Velha, Lisboa 2790-134
    Portugal

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  • Novartis Investigative Site

    Carnaxide, 2799-523
    Portugal

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  • Novartis Investigative Site

    Carnaxide 2270157, 2799-523
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  • Novartis Investigative Site

    Coimbra, 3004-561
    Portugal

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  • Novartis Investigative Site

    Coimbra 2740637, 3004-561
    Portugal

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  • Novartis Investigative Site

    Lisboa, 1649 035
    Portugal

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  • Novartis Investigative Site

    Lisbon, 1649-035
    Portugal

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  • Novartis Investigative Site

    Lisbon 2267057, 1649-035
    Portugal

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  • Novartis Investigative Site

    Porto, 4200 319
    Portugal

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    Porto 2735943, 4200 319
    Portugal

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  • Novartis Investigative Site

    Vila Nova de Gaia, 4434 502
    Portugal

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  • Novartis Investigative Site

    Vila Nova de Gaia 2732544, 4434 502
    Portugal

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  • FDI Clinical Research

    San Juan, 00927
    Puerto Rico

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  • Novartis Investigative Site

    San Juan, 00927
    Puerto Rico

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  • FDI Clinical Research

    San Juan 4568127, 00927
    Puerto Rico

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  • Novartis Investigative Site

    Singapore, Singapore S308433
    Singapore

    Active - Recruiting

  • Novartis Investigative Site

    Singapore 1880252, Singapore S308433
    Singapore

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  • Novartis Investigative Site

    Sevilla, Andalucia 41009
    Spain

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  • Novartis Investigative Site

    Port de Sagunt, Valencia 46520
    Spain

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    Puerto De Sagunto, Valencia 46520
    Spain

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  • Novartis Investigative Site

    Port de Sagunt 2518210, Valencia 2593113 46520
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  • Novartis Investigative Site

    Barcelona, 08036
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  • Novartis Investigative Site

    Barcelona 3128760, 08036
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  • Novartis Investigative Site

    Ciudad Real, 13005
    Spain

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    Ciudad Real 2519402, 13005
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    Madrid, 28040
    Spain

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  • Novartis Investigative Site

    Madrid 3117735, 28040
    Spain

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    Seville, 41009
    Spain

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    Seville 2510911, 41009
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  • Novartis Investigative Site

    Ankara, Cankaya 06800
    Turkey

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    Bursa, Gorukle 16059
    Turkey

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    Istanbul, 34093
    Turkey

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    Mersin, 33110
    Turkey

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    Talas / Kayseri, 38039
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    Talas Kayseri, 38039
    Turkey

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    Ankara, Bilkent-Cankaya 06800
    Turkey (Türkiye)

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    Ankara 323786, Bilkent-Cankaya 06800
    Turkey (Türkiye)

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  • Novartis Investigative Site

    Istanbul, Fatih 34093
    Turkey (Türkiye)

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  • Novartis Investigative Site

    Istanbul 745044, Fatih 34093
    Turkey (Türkiye)

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  • Novartis Investigative Site

    Kayseri, Melikgazi 38039
    Turkey (Türkiye)

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  • Novartis Investigative Site

    Kayseri 308464, Melikgazi 38039
    Turkey (Türkiye)

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  • Novartis Investigative Site

    Bursa, Nilufer 16059
    Turkey (Türkiye)

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    Bursa 750269, Nilufer 16059
    Turkey (Türkiye)

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    Mersin, Yenisehir 33110
    Turkey (Türkiye)

    Completed

  • Novartis Investigative Site

    Mersin 304531, Yenisehir 33110
    Turkey (Türkiye)

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    Cambridge, CB2 0QQ
    United Kingdom

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  • Novartis Investigative Site

    Cambridge 2653941, CB2 0QQ
    United Kingdom

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    Leicester, LE5 4PW
    United Kingdom

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    Leicester 2644668, LE5 4PW
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  • AKDHC Medical Research ServicesLLC

    Phoenix, Arizona 85016
    United States

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  • Novartis Investigative Site

    Phoenix, Arizona 85016
    United States

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  • AKDHC Medical Research ServicesLLC

    Phoenix 5308655, Arizona 5551752 85016
    United States

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    Fontana, California 92335
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  • Univ Calif Irvine

    Irvine, California 92697
    United States

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    Loma Linda, California 92354
    United States

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  • Ronald Reagan UCLA Medical Center

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Loma Linda University

    San Bernardino, California 92408
    United States

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    Sylmar, California 91342
    United States

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  • Kaiser Permanente Fontana

    Fontana 5349755, California 5332921 92335
    United States

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  • Univ Calif Irvine

    Irvine 5359777, California 5332921 92697
    United States

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  • Loma Linda University

    Loma Linda 5367696, California 5332921 92354
    United States

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  • Ronald Reagan UCLA Medical Center

    Los Angeles 5368361, California 5332921 90095
    United States

    Site Not Available

  • Loma Linda University

    San Bernardino 5391710, California 5332921 92408
    United States

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  • Olive View UCLA Medical Center

    Sylmar 5400784, California 5332921 91342
    United States

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    Aurora, Colorado 80045
    United States

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  • University of Colorado Denver

    Aurora 5412347, Colorado 5417618 80045
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    Hollywood, Florida 33021
    United States

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    Jacksonville, Florida 32224
    United States

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    Orlando, Florida 32806
    United States

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    Riverview, Florida 33578
    United States

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    Hollywood 4158928, Florida 4155751 33021
    United States

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    Jacksonville 4160021, Florida 4155751 32224
    United States

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  • Nephrology Associates Of Central FL

    Orlando 4167147, Florida 4155751 32806
    United States

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    Riverview 4170156, Florida 4155751 33578
    United States

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    Hinsdale, Illinois 60521
    United States

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  • Novartis Investigative Site

    Hinsdale, Illinois 60521
    United States

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    Hinsdale 4896012, Illinois 4896861 60521
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    Wichita, Kansas 67214
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    Wichita 4281730, Kansas 4273857 67214
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    New Orleans, Louisiana 70121
    United States

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    New Orleans 4335045, Louisiana 4331987 70121
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    Baltimore, Maryland 21287
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    Baltimore, Maryland 21287
    United States

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    Baltimore 4347778, Maryland 4361885 21287
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    Boston, Massachusetts 02115
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    Boston 4930956, Massachusetts 6254926 02115
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    Rochester, Minnesota 55905
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    Rochester 5043473, Minnesota 5037779 55905
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    Omaha, Nebraska 68198
    United States

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    Omaha 5074472, Nebraska 5073708 68198
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    East Setauket, New York 11733
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    East Setauket 5116060, New York 5128638 11733
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    Cleveland, Ohio 44195
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    Cleveland 5150529, Ohio 5165418 44195
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    Philadelphia, Pennsylvania 19140
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    Pittsburgh, Pennsylvania 15212
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    Philadelphia 4560349, Pennsylvania 6254927 19140
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    Pittsburgh 5206379, Pennsylvania 6254927 15212
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    Dallas, Texas 75204
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    Houston, Texas 77054
    United States

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  • Dallas Nephrology Associates

    Dallas 4684888, Texas 4736286 75204
    United States

    Site Not Available

  • Prolato Clinical Research Center

    Houston 4699066, Texas 4736286 77054
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • Virginia Commonwealth University

    Richmond 4781708, Virginia 6254928 23298
    United States

    Site Not Available

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