Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06291376




Registration number
NCT06291376
Ethics application status
Date submitted
26/02/2024
Date registered
4/03/2024

Titles & IDs
Public title
Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Immunoglobulin A Nephropathy (IgAN)
Secondary ID [1] 0 0
D928FC00001
Universal Trial Number (UTN)
Trial acronym
ICAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immunoglobulin A Nephropathy 0 0
IgAN 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ravulizumab
Treatment: Drugs - Placebo

Experimental: Ravulizumab IV q8w - Participants will receive a weight-based loading dose on Day 1 followed by weight-based maintenance dosing initiated on Day 15, and then administered every 8 weeks (q8w).

Participants in the exploratory group will receive open-label weight based loading dose on Day 1 followed by open label weight based maintenance dose on Day 15 and q8weeks after.

Placebo comparator: Placebo IV q8w - Participants will receive a weight-based loading dose on Day 1 followed by weight-based maintenance dosing initiated on Day 15, and then administered q8w.


Treatment: Drugs: Ravulizumab
Participants will receive ravulizumab via weight-based intravenous (IV) infusion.

Treatment: Drugs: Placebo
Participants will receive placebo via weight-based IV infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Week 34
Timepoint [1] 0 0
Baseline, Week 34
Primary outcome [2] 0 0
Glomerular Filtration Rate (eGFR) Over 106 Weeks
Timepoint [2] 0 0
Up to Week 106
Secondary outcome [1] 0 0
Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Weeks 10, 26, 34, 50, and 106
Timepoint [1] 0 0
Baseline, Weeks 10, 26, 34, 50, and 106
Secondary outcome [2] 0 0
Change From Baseline in eGFR at Weeks 34, 50, and 106
Timepoint [2] 0 0
Baseline, Weeks 34, 50, and 106
Secondary outcome [3] 0 0
Change From Baseline in Albuminuria Based on Urine Albumin to Creatinine Ratio (UACR) at Weeks 10, 26, 34, 50, and 106
Timepoint [3] 0 0
Baseline, Weeks 10, 26, 34,50, and 106
Secondary outcome [4] 0 0
Reduction in 24-hour UPCR = 50% From Baseline to Weeks 10, 26, 34, 50, and 106
Timepoint [4] 0 0
Baseline, Weeks 10, 26, 34, 50, and 106
Secondary outcome [5] 0 0
Number of Participants With Partial Remission at Weeks 34, 50, and 106
Timepoint [5] 0 0
Weeks 34, 50, and 106
Secondary outcome [6] 0 0
Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Weeks 34, 50, and 106
Timepoint [6] 0 0
Baseline, Weeks 34, 50, and 106
Secondary outcome [7] 0 0
Number of Participants With Composite Kidney Failure Endpoint
Timepoint [7] 0 0
Baseline up to Week 106
Secondary outcome [8] 0 0
Reduction in 24-hour UPCR = 50% From Baseline at both Weeks 34 and 106
Timepoint [8] 0 0
Baseline, Weeks 34 and 106
Secondary outcome [9] 0 0
Number of Participants With Kidney Hierarchical Composite Endpoint
Timepoint [9] 0 0
Baseline up to Week 106

Eligibility
Key inclusion criteria
* Documentation of IgAN diagnosis established on kidney biopsy obtained any time prior to or during the Screening Period.
* UPCR = 0.75 g/g or UP =1 g/day from the mean of two 24-hour urine collections during Screening.
* Estimated GFR = 30 mL/min/1.73 m2 at Screening.
* Exploratory Cohort: eGFR 20-29 mL/min/1.73 m2 at Screening. A kidney biopsy is required within 6 months prior to Screening or during the Screening Period.
* Presence of hematuria as defined by a positive result on urine dipstick for blood or = 5 red blood cells (RBCs)/high power field microscopy on urine sediment during or within 3 months of Screening.
* Stable and maximum allowed or tolerated RASI (ACEI and/or ARB) dose for = 3 months prior to Screening with no planned change during Screening through Week 106.
* Participants who are on an SGLT2I, ERA, or MRA must be on a stable and maximum allowed or tolerated dose for = 3 months prior to Screening with no planned change through Week 106.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 celiac disease).
* Concomitant clinically significant renal disease other than IgAN.
* Prior use of immunosuppressive treatment for IgAN within 6 months of screening.
* Uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8.5%.
* Clinically active Henoch-Schonlein purpura (IgA vasculitis) requiring ongoing systemic immunosuppressive therapy at Screening.
* History of kidney transplant or planned kidney transplant during the Treatment Period.
* Splenectomy or functional asplenia.
* History of Neisseria meningitidis infection.
* Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/10/2029
Actual
Sample size
Target
470
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Canberra
Recruitment hospital [2] 0 0
Research Site - Clayton
Recruitment hospital [3] 0 0
Research Site - Concord
Recruitment hospital [4] 0 0
Research Site - Herston
Recruitment hospital [5] 0 0
Research Site - Liverpool
Recruitment hospital [6] 0 0
Research Site - Perth
Recruitment hospital [7] 0 0
Research Site - Southport
Recruitment hospital [8] 0 0
Research Site - St Albans
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
2170 - Liverpool
Recruitment postcode(s) [6] 0 0
6000 - Perth
Recruitment postcode(s) [7] 0 0
4222 - Southport
Recruitment postcode(s) [8] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maine
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Wisconsin
Country [22] 0 0
Argentina
State/province [22] 0 0
Ciudad Autonoma Bs As
Country [23] 0 0
Argentina
State/province [23] 0 0
Córdoba
Country [24] 0 0
Argentina
State/province [24] 0 0
La Plata
Country [25] 0 0
Argentina
State/province [25] 0 0
Rosario
Country [26] 0 0
Argentina
State/province [26] 0 0
San Luis
Country [27] 0 0
Austria
State/province [27] 0 0
Graz
Country [28] 0 0
Austria
State/province [28] 0 0
Innsbruck
Country [29] 0 0
Austria
State/province [29] 0 0
Linz
Country [30] 0 0
Belgium
State/province [30] 0 0
Brussels
Country [31] 0 0
Belgium
State/province [31] 0 0
Edegem
Country [32] 0 0
Belgium
State/province [32] 0 0
Leuven
Country [33] 0 0
Belgium
State/province [33] 0 0
Liège
Country [34] 0 0
Belgium
State/province [34] 0 0
Roeselare
Country [35] 0 0
Brazil
State/province [35] 0 0
Belo Horizonte
Country [36] 0 0
Brazil
State/province [36] 0 0
Botucatu
Country [37] 0 0
Brazil
State/province [37] 0 0
Curitiba
Country [38] 0 0
Brazil
State/province [38] 0 0
Fortaleza
Country [39] 0 0
Brazil
State/province [39] 0 0
Recife
Country [40] 0 0
Brazil
State/province [40] 0 0
Ribeirão Preto
Country [41] 0 0
Brazil
State/province [41] 0 0
S.J. Do Rio Preto
Country [42] 0 0
Brazil
State/province [42] 0 0
Salvador
Country [43] 0 0
Brazil
State/province [43] 0 0
São Paulo
Country [44] 0 0
Canada
State/province [44] 0 0
Manitoba
Country [45] 0 0
Canada
State/province [45] 0 0
Ontario
Country [46] 0 0
Chile
State/province [46] 0 0
Araucania
Country [47] 0 0
Chile
State/province [47] 0 0
Providencia
Country [48] 0 0
Chile
State/province [48] 0 0
Santiago
Country [49] 0 0
Chile
State/province [49] 0 0
Valdivia
Country [50] 0 0
China
State/province [50] 0 0
Baotou
Country [51] 0 0
China
State/province [51] 0 0
Beijing
Country [52] 0 0
China
State/province [52] 0 0
Changsha
Country [53] 0 0
China
State/province [53] 0 0
Changzhou
Country [54] 0 0
China
State/province [54] 0 0
Chengdu
Country [55] 0 0
China
State/province [55] 0 0
Chongqing
Country [56] 0 0
China
State/province [56] 0 0
Guangzhou
Country [57] 0 0
China
State/province [57] 0 0
Hangzhou
Country [58] 0 0
China
State/province [58] 0 0
Jinan
Country [59] 0 0
China
State/province [59] 0 0
Jinhua
Country [60] 0 0
China
State/province [60] 0 0
Lanzhou
Country [61] 0 0
China
State/province [61] 0 0
Luoyang
Country [62] 0 0
China
State/province [62] 0 0
Nanchang
Country [63] 0 0
China
State/province [63] 0 0
Nanjing
Country [64] 0 0
China
State/province [64] 0 0
Ningbo
Country [65] 0 0
China
State/province [65] 0 0
Qingdao
Country [66] 0 0
China
State/province [66] 0 0
Shanghai
Country [67] 0 0
China
State/province [67] 0 0
Shenyang
Country [68] 0 0
China
State/province [68] 0 0
Shenzhen
Country [69] 0 0
China
State/province [69] 0 0
Urumqi
Country [70] 0 0
China
State/province [70] 0 0
Wuhan
Country [71] 0 0
China
State/province [71] 0 0
Wuxi
Country [72] 0 0
China
State/province [72] 0 0
Xian
Country [73] 0 0
China
State/province [73] 0 0
Yantai
Country [74] 0 0
China
State/province [74] 0 0
Yibin
Country [75] 0 0
China
State/province [75] 0 0
Yinchuan
Country [76] 0 0
China
State/province [76] 0 0
Zhanjiang
Country [77] 0 0
China
State/province [77] 0 0
Zhengzhou
Country [78] 0 0
Colombia
State/province [78] 0 0
Barranquilla
Country [79] 0 0
Colombia
State/province [79] 0 0
Bogota
Country [80] 0 0
Colombia
State/province [80] 0 0
Cali
Country [81] 0 0
Colombia
State/province [81] 0 0
Manizales
Country [82] 0 0
Colombia
State/province [82] 0 0
Medellín
Country [83] 0 0
Colombia
State/province [83] 0 0
Rionegro
Country [84] 0 0
Czechia
State/province [84] 0 0
Nový Jicín
Country [85] 0 0
Czechia
State/province [85] 0 0
Praha 2
Country [86] 0 0
Czechia
State/province [86] 0 0
Praha 4
Country [87] 0 0
France
State/province [87] 0 0
Amiens Cedex 1
Country [88] 0 0
France
State/province [88] 0 0
Bayonne
Country [89] 0 0
France
State/province [89] 0 0
Brest Cedex
Country [90] 0 0
France
State/province [90] 0 0
Chambéry Cedex
Country [91] 0 0
France
State/province [91] 0 0
Clermont Ferrand
Country [92] 0 0
France
State/province [92] 0 0
Le Kremlin-Bicêtre
Country [93] 0 0
France
State/province [93] 0 0
Marseille
Country [94] 0 0
France
State/province [94] 0 0
Nantes
Country [95] 0 0
France
State/province [95] 0 0
Nice cedex 1
Country [96] 0 0
France
State/province [96] 0 0
Paris
Country [97] 0 0
France
State/province [97] 0 0
Sr Priest En Jarez
Country [98] 0 0
France
State/province [98] 0 0
Strasbourg
Country [99] 0 0
France
State/province [99] 0 0
Toulouse
Country [100] 0 0
Germany
State/province [100] 0 0
Aachen
Country [101] 0 0
Germany
State/province [101] 0 0
Berlin
Country [102] 0 0
Germany
State/province [102] 0 0
Erlangen
Country [103] 0 0
Germany
State/province [103] 0 0
Essen
Country [104] 0 0
Germany
State/province [104] 0 0
Greifswald
Country [105] 0 0
Germany
State/province [105] 0 0
Hannover
Country [106] 0 0
Germany
State/province [106] 0 0
Köln
Country [107] 0 0
Germany
State/province [107] 0 0
Mainz
Country [108] 0 0
Germany
State/province [108] 0 0
München
Country [109] 0 0
Germany
State/province [109] 0 0
Villingen-Schwenningen
Country [110] 0 0
Greece
State/province [110] 0 0
Athens
Country [111] 0 0
Greece
State/province [111] 0 0
Heraclion
Country [112] 0 0
Greece
State/province [112] 0 0
Patras
Country [113] 0 0
Greece
State/province [113] 0 0
Thessaloniki
Country [114] 0 0
Hong Kong
State/province [114] 0 0
Hong Kong
Country [115] 0 0
Hong Kong
State/province [115] 0 0
Lai Chi Kok
Country [116] 0 0
Hong Kong
State/province [116] 0 0
Shatin
Country [117] 0 0
Hungary
State/province [117] 0 0
Budapest
Country [118] 0 0
Hungary
State/province [118] 0 0
Miskolc
Country [119] 0 0
Israel
State/province [119] 0 0
Haifa
Country [120] 0 0
Israel
State/province [120] 0 0
Jerusalem
Country [121] 0 0
Israel
State/province [121] 0 0
Nazareth
Country [122] 0 0
Israel
State/province [122] 0 0
Petah Tikva
Country [123] 0 0
Israel
State/province [123] 0 0
Tel Aviv
Country [124] 0 0
Italy
State/province [124] 0 0
Agrigento
Country [125] 0 0
Italy
State/province [125] 0 0
Bari
Country [126] 0 0
Italy
State/province [126] 0 0
Bologna
Country [127] 0 0
Italy
State/province [127] 0 0
Brescia
Country [128] 0 0
Italy
State/province [128] 0 0
Cagliari
Country [129] 0 0
Italy
State/province [129] 0 0
Firenze
Country [130] 0 0
Italy
State/province [130] 0 0
Milano
Country [131] 0 0
Italy
State/province [131] 0 0
Padova
Country [132] 0 0
Italy
State/province [132] 0 0
Parma
Country [133] 0 0
Italy
State/province [133] 0 0
Piacenza
Country [134] 0 0
Italy
State/province [134] 0 0
Torino
Country [135] 0 0
Italy
State/province [135] 0 0
Torrette
Country [136] 0 0
Italy
State/province [136] 0 0
Verona
Country [137] 0 0
Japan
State/province [137] 0 0
Ashikaga
Country [138] 0 0
Japan
State/province [138] 0 0
Bunkyo-ku
Country [139] 0 0
Japan
State/province [139] 0 0
Chiba-Shi
Country [140] 0 0
Japan
State/province [140] 0 0
Chiba-shi
Country [141] 0 0
Japan
State/province [141] 0 0
Fukuoka-shi
Country [142] 0 0
Japan
State/province [142] 0 0
Kamakura
Country [143] 0 0
Japan
State/province [143] 0 0
Kasugai-shi
Country [144] 0 0
Japan
State/province [144] 0 0
Kitakyushu-shi
Country [145] 0 0
Japan
State/province [145] 0 0
Kobe-shi
Country [146] 0 0
Japan
State/province [146] 0 0
Matsumoto-shi
Country [147] 0 0
Japan
State/province [147] 0 0
Matsuyama-shi
Country [148] 0 0
Japan
State/province [148] 0 0
Nagoya
Country [149] 0 0
Japan
State/province [149] 0 0
Osaka-shi
Country [150] 0 0
Japan
State/province [150] 0 0
Sapporo-shi
Country [151] 0 0
Japan
State/province [151] 0 0
Toyota-Shi
Country [152] 0 0
Japan
State/province [152] 0 0
Urayasu-shi
Country [153] 0 0
Korea, Republic of
State/province [153] 0 0
Anyang-si
Country [154] 0 0
Korea, Republic of
State/province [154] 0 0
Busan
Country [155] 0 0
Korea, Republic of
State/province [155] 0 0
Deagu
Country [156] 0 0
Korea, Republic of
State/province [156] 0 0
Gwangju
Country [157] 0 0
Korea, Republic of
State/province [157] 0 0
Gyeonggi-do
Country [158] 0 0
Korea, Republic of
State/province [158] 0 0
Seoul
Country [159] 0 0
Korea, Republic of
State/province [159] 0 0
Suwon-si
Country [160] 0 0
Malaysia
State/province [160] 0 0
Ipoh
Country [161] 0 0
Malaysia
State/province [161] 0 0
Johor Bahru
Country [162] 0 0
Malaysia
State/province [162] 0 0
Kuala Lumpur
Country [163] 0 0
Malaysia
State/province [163] 0 0
Seremban
Country [164] 0 0
Malaysia
State/province [164] 0 0
Taiping
Country [165] 0 0
Mexico
State/province [165] 0 0
Chihuahua
Country [166] 0 0
Mexico
State/province [166] 0 0
Culiacan
Country [167] 0 0
Mexico
State/province [167] 0 0
Guadalajara
Country [168] 0 0
Mexico
State/province [168] 0 0
Juriquilla
Country [169] 0 0
Mexico
State/province [169] 0 0
Mexico
Country [170] 0 0
Mexico
State/province [170] 0 0
Zapopan
Country [171] 0 0
Netherlands
State/province [171] 0 0
Amsterdam
Country [172] 0 0
Netherlands
State/province [172] 0 0
Groningen
Country [173] 0 0
Netherlands
State/province [173] 0 0
Nijmegen
Country [174] 0 0
Poland
State/province [174] 0 0
Bialystok
Country [175] 0 0
Poland
State/province [175] 0 0
Kraków
Country [176] 0 0
Poland
State/province [176] 0 0
Lublin
Country [177] 0 0
Poland
State/province [177] 0 0
Olsztyn
Country [178] 0 0
Poland
State/province [178] 0 0
Poznan
Country [179] 0 0
Poland
State/province [179] 0 0
Szczecin
Country [180] 0 0
Poland
State/province [180] 0 0
Warszawa
Country [181] 0 0
Poland
State/province [181] 0 0
Lódz
Country [182] 0 0
Saudi Arabia
State/province [182] 0 0
Dammam
Country [183] 0 0
Saudi Arabia
State/province [183] 0 0
Jeddah
Country [184] 0 0
Saudi Arabia
State/province [184] 0 0
Riyadh
Country [185] 0 0
Slovakia
State/province [185] 0 0
Banská Bystrica
Country [186] 0 0
Slovakia
State/province [186] 0 0
Bratislava
Country [187] 0 0
Slovakia
State/province [187] 0 0
Martin
Country [188] 0 0
Spain
State/province [188] 0 0
Alcalá de Henares
Country [189] 0 0
Spain
State/province [189] 0 0
La Coruña
Country [190] 0 0
Spain
State/province [190] 0 0
Lérida
Country [191] 0 0
Spain
State/province [191] 0 0
Madrid
Country [192] 0 0
Spain
State/province [192] 0 0
Málaga
Country [193] 0 0
Spain
State/province [193] 0 0
Oviedo
Country [194] 0 0
Spain
State/province [194] 0 0
Sant Joan Despí
Country [195] 0 0
Spain
State/province [195] 0 0
Sevilla
Country [196] 0 0
Spain
State/province [196] 0 0
Tarragona
Country [197] 0 0
Spain
State/province [197] 0 0
Valencia
Country [198] 0 0
Spain
State/province [198] 0 0
Zaragoza
Country [199] 0 0
Taiwan
State/province [199] 0 0
Kaohsiung City
Country [200] 0 0
Taiwan
State/province [200] 0 0
Kaohsiung
Country [201] 0 0
Taiwan
State/province [201] 0 0
New Taipei City
Country [202] 0 0
Taiwan
State/province [202] 0 0
Taichung City
Country [203] 0 0
Taiwan
State/province [203] 0 0
Taichung
Country [204] 0 0
Taiwan
State/province [204] 0 0
Tainan City
Country [205] 0 0
Taiwan
State/province [205] 0 0
Taipei
Country [206] 0 0
Taiwan
State/province [206] 0 0
Taoyuan City
Country [207] 0 0
Thailand
State/province [207] 0 0
Bangkok
Country [208] 0 0
Thailand
State/province [208] 0 0
Chaingmai
Country [209] 0 0
Thailand
State/province [209] 0 0
Khlong Luang
Country [210] 0 0
Thailand
State/province [210] 0 0
Khon Kaen
Country [211] 0 0
Turkey
State/province [211] 0 0
Ankara
Country [212] 0 0
Turkey
State/province [212] 0 0
Bursa
Country [213] 0 0
Turkey
State/province [213] 0 0
Istanbul
Country [214] 0 0
Turkey
State/province [214] 0 0
Kayseri
Country [215] 0 0
Turkey
State/province [215] 0 0
Kocaeli
Country [216] 0 0
Turkey
State/province [216] 0 0
Konya
Country [217] 0 0
United Kingdom
State/province [217] 0 0
Cambridge
Country [218] 0 0
United Kingdom
State/province [218] 0 0
Doncaster
Country [219] 0 0
United Kingdom
State/province [219] 0 0
Leicester
Country [220] 0 0
United Kingdom
State/province [220] 0 0
London
Country [221] 0 0
United Kingdom
State/province [221] 0 0
Salford
Country [222] 0 0
United Kingdom
State/province [222] 0 0
Stevenage

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alexion Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alexion Pharmaceuticals, Inc. (Sponsor)
Address 0 0
Country 0 0
Phone 0 0
1-855-752-2356
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06291376