Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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/NCT06087835




Registration number
NCT06087835
Ethics application status
Date submitted
4/10/2023
Date registered
18/10/2023

Titles & IDs
Public title
Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants With Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria)
Scientific title
A Phase III, Randomised, Multicentre, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin Alone in Participants With Chronic Kidney Disease and High Proteinuria
Secondary ID [1] 0 0
D4325C00010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease With High Proteinuria 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

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

Experimental: Zibotentan/Dapagliflozin dose A or Zibotentan/Dapagliflozin dose B - Drug dose (dose A or B) are determined based on eGFR values. Participants will receive daily oral dose of zibotentan/dapagliflozin in fixed dose combination.

Active comparator: Dapagliflozin alone - Participants will receive daily oral dose of dapagliflozin.


Treatment: Drugs: Zibotentan/Dapagliflozin
Participants will receive zibotentan/dapagliflozin in fixed-dose combination as per the arms they are randomized to

Treatment: Drugs: Dapagliflozin
Participants will receive dapagliflozin as per the arms they are randomized to
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in eGFR from baseline
Timepoint [1] 0 0
At month 24
Secondary outcome [1] 0 0
Change in Urine Protein to Creatinine Ratio (UPCR) from baseline to each participant's mean level
Timepoint [1] 0 0
Across the visits from Day 15 up to Month 24
Secondary outcome [2] 0 0
Change in UACR from baseline to each participant's mean level
Timepoint [2] 0 0
Across the visits from Day 15 up to Month 24
Secondary outcome [3] 0 0
Time to the first occurrence of any of the components of the renal composite endpoint of 40% sustained decline in eGFR or ESKD or renal death
Timepoint [3] 0 0
Through study completion, approximately 43 months
Secondary outcome [4] 0 0
Change in systolic blood pressure from baseline to each participant's mean level
Timepoint [4] 0 0
Across the visits from Day 15 up to Month 24
Secondary outcome [5] 0 0
Proportion of participants achieving Urine Protein to Creatinine Ratio (UPCR) < 1000 mg/g and > 30% reduction from baseline for each participant's mean level
Timepoint [5] 0 0
Across the visits from Day 15 up to Month 24

Eligibility
Key inclusion criteria
1. Participant must be = 18 years of age and of legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent.
2. Diagnosis of CKD, defined as eGFR = 20 and < 90 mL/min/1.73 m2 and UACR > 700 mg/g (> 79 mg/mmol) or UPCR > 1000 mg/g (> 113 mg/mmoL).
3. All female participants must have a negative serum pregnancy test result at screening.
4. Female participants must be either

* not of child-bearing potential or
* women of child bearing potential (WOCBP) using at least one highly effective birth control method for at least 3 months prior to first dose of study intervention
5. Capable of giving signed informed consent
6. Provision of signed informed consent prior to any study specific procedure.
7. Provision of electronic informed consent prior to completion of the optional Study Participant Feedback Questionnaire (SPFQ).
8. Provision of signed and dated written Optional Genomics Initiative Research Information and Consent Form prior to collection of samples for optional genomics imitative research that supports the Genomic Initiative.
9. Receiving RAASi therapy (ACEi or ARB), and for the patient maximum tolerated labelled daily dose, that has been stable for at least 4 weeks.
Minimum age
18 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants with NYHA class III or class IV Congestive HF at the time of enrolment.
2. Participants hospitalised for HF during the last 6 month prior to screening.
3. Evidence of rales or jugular venous distention on physical examination.
4. Participants with type 1 diabetes mellitus.
5. History of any life-threatening ventricular dysrhythmia (continuous or paroxysmal).
6. Blood pressure above 160 mmHg systolic.
7. Blood pressure below 90 mmHg systolic.
8. Participants hospitalised for heart disease or cardiac procedures or for COVID-19 during the last 3 months prior to screening.
9. History of solid organ transplantation or bone marrow transplant.
10. History or ongoing allergy/hypersensitivity, as judged by the Investigator, to SGLT2i therapy (eg, dapagliflozin, canagliflozin, empagliflozin or other SGLT2 inhibitors) or Endothelin Receptor Antagonists (eg, ambrisentan, atrasentan, bosentan, or other).
11. Any condition with a life expectancy of less than 2 years based on investigator´s clinical judgment.
12. Malignancy within the past 5 years. Exceptions to this criterion include non-melanoma skin cancer and curatively treated cervical carcinoma in situ.
13. Significant liver disease as judged by the investigator or severe hepatic impairment with AST or ALT > 3 × ULN; or total bilirubin > 2 × ULN at time of screening. An isolated increase in bilirubin in participants with known Gilbert's syndrome is not a reason for exclusion.
14. Known blood-borne diseases.
15. Clinically significant, unstable, or uncontrolled medical condition as assessed by the Investigator.
16. Participants on renal replacement therapy or previous kidney transplant.
17. Known history of drug or alcohol abuse within 12 months of screening.
18. Participants on treatment with strong or moderate CYP3A4 inducer.
19. Participants on systemic immunosuppression therapy other than stable maintenance therapy defined as prednisone 10 mg/day (or equivalent) or less, aziothioprine 100 mg/day or less; MMF 1000 mg/day or less for at least 3 months prior to Visit 1. Inhaled, nasal or dermatological steroids are also allowed.
20. Participants treated or expecting to be treated with tolvaptan, any other ERAs, or budesonide (where used to treat IBD or IgAN).
21. Participation in another clinical study with a study intervention administered in the last 3 months.

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
7/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Gosford
Recruitment hospital [2] 0 0
Research Site - Meadowbrook
Recruitment hospital [3] 0 0
Research Site - Perth
Recruitment hospital [4] 0 0
Research Site - Reservoir
Recruitment hospital [5] 0 0
Research Site - Southport
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
4131 - Meadowbrook
Recruitment postcode(s) [3] 0 0
6000 - Perth
Recruitment postcode(s) [4] 0 0
3021 - Reservoir
Recruitment postcode(s) [5] 0 0
3073 - Reservoir
Recruitment postcode(s) [6] 0 0
4222 - Southport
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
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
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
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Rhode Island
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
Argentina
State/province [25] 0 0
Buenos Aires
Country [26] 0 0
Argentina
State/province [26] 0 0
Ciudad de Buenos Aires
Country [27] 0 0
Argentina
State/province [27] 0 0
Mar del Plata
Country [28] 0 0
Argentina
State/province [28] 0 0
Rosario
Country [29] 0 0
Argentina
State/province [29] 0 0
Santa Fe
Country [30] 0 0
Austria
State/province [30] 0 0
Feldkirch
Country [31] 0 0
Austria
State/province [31] 0 0
Wien
Country [32] 0 0
Brazil
State/province [32] 0 0
Belem
Country [33] 0 0
Brazil
State/province [33] 0 0
Botucatu
Country [34] 0 0
Brazil
State/province [34] 0 0
Joinville
Country [35] 0 0
Brazil
State/province [35] 0 0
Sao Jose Do Rio Preto
Country [36] 0 0
Brazil
State/province [36] 0 0
São Paulo
Country [37] 0 0
Bulgaria
State/province [37] 0 0
Dobrich
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Pleven
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Plovdiv
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Sofia
Country [41] 0 0
Bulgaria
State/province [41] 0 0
Stara Zagora
Country [42] 0 0
Canada
State/province [42] 0 0
Ontario
Country [43] 0 0
Canada
State/province [43] 0 0
Quebec
Country [44] 0 0
China
State/province [44] 0 0
Baotou
Country [45] 0 0
China
State/province [45] 0 0
Beijing
Country [46] 0 0
China
State/province [46] 0 0
Changsha
Country [47] 0 0
China
State/province [47] 0 0
Chengdu
Country [48] 0 0
China
State/province [48] 0 0
Chongqing
Country [49] 0 0
China
State/province [49] 0 0
Deyang
Country [50] 0 0
China
State/province [50] 0 0
Foshan
Country [51] 0 0
China
State/province [51] 0 0
Guangzhou
Country [52] 0 0
China
State/province [52] 0 0
Hangzhou
Country [53] 0 0
China
State/province [53] 0 0
Hengyang
Country [54] 0 0
China
State/province [54] 0 0
Linhai
Country [55] 0 0
China
State/province [55] 0 0
Nanjing
Country [56] 0 0
China
State/province [56] 0 0
Nanning
Country [57] 0 0
China
State/province [57] 0 0
Ningbo
Country [58] 0 0
China
State/province [58] 0 0
Pingxiang
Country [59] 0 0
China
State/province [59] 0 0
Shanghai
Country [60] 0 0
China
State/province [60] 0 0
Shantou
Country [61] 0 0
China
State/province [61] 0 0
Shenzhen
Country [62] 0 0
China
State/province [62] 0 0
Wenzhou
Country [63] 0 0
China
State/province [63] 0 0
Wuhan
Country [64] 0 0
China
State/province [64] 0 0
Wuxi
Country [65] 0 0
China
State/province [65] 0 0
XI 'an
Country [66] 0 0
China
State/province [66] 0 0
Xiamen
Country [67] 0 0
China
State/province [67] 0 0
Yantai
Country [68] 0 0
China
State/province [68] 0 0
Yibin
Country [69] 0 0
China
State/province [69] 0 0
Yinchuan
Country [70] 0 0
China
State/province [70] 0 0
Zhuzhou
Country [71] 0 0
China
State/province [71] 0 0
Zigong
Country [72] 0 0
Denmark
State/province [72] 0 0
Aalborg
Country [73] 0 0
Denmark
State/province [73] 0 0
Aarhus
Country [74] 0 0
Denmark
State/province [74] 0 0
Herlev
Country [75] 0 0
Denmark
State/province [75] 0 0
Herning
Country [76] 0 0
Denmark
State/province [76] 0 0
Roskilde
Country [77] 0 0
France
State/province [77] 0 0
La Tronche
Country [78] 0 0
France
State/province [78] 0 0
Mulhouse
Country [79] 0 0
France
State/province [79] 0 0
Nice
Country [80] 0 0
France
State/province [80] 0 0
Nimes
Country [81] 0 0
France
State/province [81] 0 0
Rouen
Country [82] 0 0
France
State/province [82] 0 0
St-Priest-en-Jarez
Country [83] 0 0
France
State/province [83] 0 0
Strasbourg
Country [84] 0 0
France
State/province [84] 0 0
Tours
Country [85] 0 0
Germany
State/province [85] 0 0
Aachen
Country [86] 0 0
Germany
State/province [86] 0 0
Bad Oeynhausen
Country [87] 0 0
Germany
State/province [87] 0 0
Berlin
Country [88] 0 0
Germany
State/province [88] 0 0
Dresden
Country [89] 0 0
Germany
State/province [89] 0 0
Fulda
Country [90] 0 0
Germany
State/province [90] 0 0
Geilenkirchen
Country [91] 0 0
Germany
State/province [91] 0 0
Hannover
Country [92] 0 0
Germany
State/province [92] 0 0
Köln
Country [93] 0 0
Germany
State/province [93] 0 0
Mainz
Country [94] 0 0
Germany
State/province [94] 0 0
München
Country [95] 0 0
India
State/province [95] 0 0
Bangalore
Country [96] 0 0
India
State/province [96] 0 0
Belagavi
Country [97] 0 0
India
State/province [97] 0 0
Delhi
Country [98] 0 0
India
State/province [98] 0 0
Dhanvantari Nagar
Country [99] 0 0
India
State/province [99] 0 0
Jaipur
Country [100] 0 0
India
State/province [100] 0 0
Nadiad
Country [101] 0 0
India
State/province [101] 0 0
New Delhi
Country [102] 0 0
Israel
State/province [102] 0 0
Ashkelon
Country [103] 0 0
Israel
State/province [103] 0 0
Haifa
Country [104] 0 0
Israel
State/province [104] 0 0
Jerusalem
Country [105] 0 0
Israel
State/province [105] 0 0
Kfar-Saba
Country [106] 0 0
Israel
State/province [106] 0 0
Nahariya
Country [107] 0 0
Israel
State/province [107] 0 0
Petah Tikva
Country [108] 0 0
Israel
State/province [108] 0 0
Ramat Gan
Country [109] 0 0
Israel
State/province [109] 0 0
Rehovot
Country [110] 0 0
Italy
State/province [110] 0 0
Bergamo
Country [111] 0 0
Italy
State/province [111] 0 0
Bologna
Country [112] 0 0
Italy
State/province [112] 0 0
Foggia
Country [113] 0 0
Italy
State/province [113] 0 0
Genoa
Country [114] 0 0
Italy
State/province [114] 0 0
Napoli
Country [115] 0 0
Italy
State/province [115] 0 0
Pisa
Country [116] 0 0
Italy
State/province [116] 0 0
Roma
Country [117] 0 0
Italy
State/province [117] 0 0
Torino
Country [118] 0 0
Italy
State/province [118] 0 0
Viterbo
Country [119] 0 0
Japan
State/province [119] 0 0
Chuo-ku
Country [120] 0 0
Japan
State/province [120] 0 0
Fujisawa-shi
Country [121] 0 0
Japan
State/province [121] 0 0
Fukui-shi
Country [122] 0 0
Japan
State/province [122] 0 0
Fukuoka-shi
Country [123] 0 0
Japan
State/province [123] 0 0
Hamada-shi
Country [124] 0 0
Japan
State/province [124] 0 0
Hashima-gun
Country [125] 0 0
Japan
State/province [125] 0 0
Kamakura-shi
Country [126] 0 0
Japan
State/province [126] 0 0
Kasuga-shi
Country [127] 0 0
Japan
State/province [127] 0 0
Kawaguchi-shi
Country [128] 0 0
Japan
State/province [128] 0 0
Kitakyushu-shi
Country [129] 0 0
Japan
State/province [129] 0 0
Kitakyusyu-shi
Country [130] 0 0
Japan
State/province [130] 0 0
Kofu-shi
Country [131] 0 0
Japan
State/province [131] 0 0
Kurume-shi
Country [132] 0 0
Japan
State/province [132] 0 0
Kusatsu-shi
Country [133] 0 0
Japan
State/province [133] 0 0
Kyoto-shi
Country [134] 0 0
Japan
State/province [134] 0 0
Matsumoto-shi
Country [135] 0 0
Japan
State/province [135] 0 0
Meguro-ku
Country [136] 0 0
Japan
State/province [136] 0 0
Minato-ku
Country [137] 0 0
Japan
State/province [137] 0 0
Minokamo shi
Country [138] 0 0
Japan
State/province [138] 0 0
Miyazaki
Country [139] 0 0
Japan
State/province [139] 0 0
Nishinomiya-Shi
Country [140] 0 0
Japan
State/province [140] 0 0
Nishinomiya-shi
Country [141] 0 0
Japan
State/province [141] 0 0
Okawa-shi
Country [142] 0 0
Japan
State/province [142] 0 0
Osaka-shi
Country [143] 0 0
Japan
State/province [143] 0 0
Oyama-shi
Country [144] 0 0
Japan
State/province [144] 0 0
Saku-shi
Country [145] 0 0
Japan
State/province [145] 0 0
Sanuki-shi
Country [146] 0 0
Japan
State/province [146] 0 0
Sapporo-shi
Country [147] 0 0
Japan
State/province [147] 0 0
Sendai-shi
Country [148] 0 0
Japan
State/province [148] 0 0
Soka-shi
Country [149] 0 0
Japan
State/province [149] 0 0
Takamatsu-shi
Country [150] 0 0
Japan
State/province [150] 0 0
Takasago-shi
Country [151] 0 0
Japan
State/province [151] 0 0
Tondabayashi-shi
Country [152] 0 0
Japan
State/province [152] 0 0
Toride-shi
Country [153] 0 0
Japan
State/province [153] 0 0
Urayasu
Country [154] 0 0
Japan
State/province [154] 0 0
Utsunomiya-shi
Country [155] 0 0
Korea, Republic of
State/province [155] 0 0
Ansan-si
Country [156] 0 0
Korea, Republic of
State/province [156] 0 0
Busan
Country [157] 0 0
Korea, Republic of
State/province [157] 0 0
Cheonan-si
Country [158] 0 0
Korea, Republic of
State/province [158] 0 0
Daegu
Country [159] 0 0
Korea, Republic of
State/province [159] 0 0
Goyang-si
Country [160] 0 0
Korea, Republic of
State/province [160] 0 0
Seoul
Country [161] 0 0
Malaysia
State/province [161] 0 0
Alor Setar
Country [162] 0 0
Malaysia
State/province [162] 0 0
Ipoh
Country [163] 0 0
Malaysia
State/province [163] 0 0
Kota Kinabalu
Country [164] 0 0
Malaysia
State/province [164] 0 0
Kuala Lumpur
Country [165] 0 0
Malaysia
State/province [165] 0 0
Seremban
Country [166] 0 0
Malaysia
State/province [166] 0 0
Seri Manjung
Country [167] 0 0
Mexico
State/province [167] 0 0
Cuautitlán
Country [168] 0 0
Mexico
State/province [168] 0 0
Cuernavaca, MOR
Country [169] 0 0
Mexico
State/province [169] 0 0
Mazatlán
Country [170] 0 0
Mexico
State/province [170] 0 0
Mexico
Country [171] 0 0
Mexico
State/province [171] 0 0
Monterrey
Country [172] 0 0
Mexico
State/province [172] 0 0
Saltillo
Country [173] 0 0
Mexico
State/province [173] 0 0
Veracruz
Country [174] 0 0
Netherlands
State/province [174] 0 0
Amersfoort
Country [175] 0 0
Netherlands
State/province [175] 0 0
Breda
Country [176] 0 0
Netherlands
State/province [176] 0 0
Dordrecht
Country [177] 0 0
Norway
State/province [177] 0 0
Bodø
Country [178] 0 0
Norway
State/province [178] 0 0
Lørenskog
Country [179] 0 0
Norway
State/province [179] 0 0
Oslo
Country [180] 0 0
Norway
State/province [180] 0 0
Stavanger
Country [181] 0 0
Norway
State/province [181] 0 0
Tromsø
Country [182] 0 0
Philippines
State/province [182] 0 0
Angeles City
Country [183] 0 0
Philippines
State/province [183] 0 0
Davao DEL SUR
Country [184] 0 0
Philippines
State/province [184] 0 0
Iloilo City
Country [185] 0 0
Philippines
State/province [185] 0 0
Manila
Country [186] 0 0
Philippines
State/province [186] 0 0
Pasig City
Country [187] 0 0
Philippines
State/province [187] 0 0
Quezon City
Country [188] 0 0
Poland
State/province [188] 0 0
Chrzanów
Country [189] 0 0
Poland
State/province [189] 0 0
Katowice
Country [190] 0 0
Poland
State/province [190] 0 0
Krakow
Country [191] 0 0
Poland
State/province [191] 0 0
Kraków
Country [192] 0 0
Poland
State/province [192] 0 0
Lublin
Country [193] 0 0
Poland
State/province [193] 0 0
Poznan
Country [194] 0 0
Poland
State/province [194] 0 0
Radom
Country [195] 0 0
Poland
State/province [195] 0 0
Rzeszów
Country [196] 0 0
Poland
State/province [196] 0 0
Szczecin
Country [197] 0 0
Poland
State/province [197] 0 0
Warszawa
Country [198] 0 0
Poland
State/province [198] 0 0
Lódz
Country [199] 0 0
Slovakia
State/province [199] 0 0
Kosice
Country [200] 0 0
Slovakia
State/province [200] 0 0
Lucenec
Country [201] 0 0
Slovakia
State/province [201] 0 0
Presov
Country [202] 0 0
Slovakia
State/province [202] 0 0
Puchov
Country [203] 0 0
Slovakia
State/province [203] 0 0
Roznava
Country [204] 0 0
Slovakia
State/province [204] 0 0
Trebišov
Country [205] 0 0
South Africa
State/province [205] 0 0
Benoni
Country [206] 0 0
South Africa
State/province [206] 0 0
Cape Town
Country [207] 0 0
South Africa
State/province [207] 0 0
Chatsworth
Country [208] 0 0
South Africa
State/province [208] 0 0
Durban
Country [209] 0 0
South Africa
State/province [209] 0 0
Lenasia
Country [210] 0 0
South Africa
State/province [210] 0 0
Midrand
Country [211] 0 0
South Africa
State/province [211] 0 0
Parow
Country [212] 0 0
South Africa
State/province [212] 0 0
Soweto
Country [213] 0 0
Spain
State/province [213] 0 0
Girona
Country [214] 0 0
Spain
State/province [214] 0 0
L'Hospitalet de Llobregat
Country [215] 0 0
Spain
State/province [215] 0 0
Lugo
Country [216] 0 0
Spain
State/province [216] 0 0
Madrid
Country [217] 0 0
Spain
State/province [217] 0 0
Majadahonda
Country [218] 0 0
Spain
State/province [218] 0 0
Sevilla
Country [219] 0 0
Spain
State/province [219] 0 0
Valencia
Country [220] 0 0
Sweden
State/province [220] 0 0
Göteborg
Country [221] 0 0
Sweden
State/province [221] 0 0
Linköping
Country [222] 0 0
Sweden
State/province [222] 0 0
Rättvik
Country [223] 0 0
Sweden
State/province [223] 0 0
Stockholm
Country [224] 0 0
Sweden
State/province [224] 0 0
Uppsala
Country [225] 0 0
Taiwan
State/province [225] 0 0
Kaohsiung city
Country [226] 0 0
Taiwan
State/province [226] 0 0
Kaohsiung
Country [227] 0 0
Taiwan
State/province [227] 0 0
New Taipei
Country [228] 0 0
Taiwan
State/province [228] 0 0
Taichung
Country [229] 0 0
Taiwan
State/province [229] 0 0
Tainan
Country [230] 0 0
Taiwan
State/province [230] 0 0
Taipei City
Country [231] 0 0
Taiwan
State/province [231] 0 0
Taipei
Country [232] 0 0
Taiwan
State/province [232] 0 0
Taoyuan
Country [233] 0 0
Thailand
State/province [233] 0 0
Bangkok
Country [234] 0 0
Thailand
State/province [234] 0 0
Chaingmai
Country [235] 0 0
Thailand
State/province [235] 0 0
Hat Yai
Country [236] 0 0
Thailand
State/province [236] 0 0
Khon Kaen
Country [237] 0 0
Thailand
State/province [237] 0 0
Ratchathewi
Country [238] 0 0
Turkey
State/province [238] 0 0
Adapazari
Country [239] 0 0
Turkey
State/province [239] 0 0
Ankara
Country [240] 0 0
Turkey
State/province [240] 0 0
Antalya
Country [241] 0 0
Turkey
State/province [241] 0 0
Bursa
Country [242] 0 0
Turkey
State/province [242] 0 0
Dinar
Country [243] 0 0
Turkey
State/province [243] 0 0
Kahramanmaras
Country [244] 0 0
Turkey
State/province [244] 0 0
Kayseri
Country [245] 0 0
Turkey
State/province [245] 0 0
Kocaeli
Country [246] 0 0
United Kingdom
State/province [246] 0 0
Cardiff
Country [247] 0 0
United Kingdom
State/province [247] 0 0
Dundee
Country [248] 0 0
United Kingdom
State/province [248] 0 0
Glasgow
Country [249] 0 0
United Kingdom
State/province [249] 0 0
London
Country [250] 0 0
United Kingdom
State/province [250] 0 0
York
Country [251] 0 0
Vietnam
State/province [251] 0 0
Ha Noi
Country [252] 0 0
Vietnam
State/province [252] 0 0
Hai Phong
Country [253] 0 0
Vietnam
State/province [253] 0 0
Ho Chi Minh City
Country [254] 0 0
Vietnam
State/province [254] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
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
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
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?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


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/NCT06087835