Trial Review

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/NCT05852938




Registration number
Help: Registration number
NCT05852938
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
2/05/2023
Date registered
Help: Date registered
10/05/2023
Date last updated
Help: Date last updated
1/04/2026

Titles & IDs
Public title
A Study of Zigakibart in Adults With IgA Nephropathy
Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy (The BEYOND Study)
Additional trial identifiers [1] 0 0
CHK02-02
Additional trial identifiers [2] 0 0
CFUB523A12301
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
IgA Nephropathy 0 0
Immunoglobulin A Nephropathy 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
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Drugs - BION-1301
Treatment: Drugs - Placebo

Experimental: BION-1301 - 600mg subcutaneous administration every 2 weeks for 104 weeks

Placebo comparator: Placebo - subcutaneous administration every 2 weeks for 104 weeks


Treatment: Drugs: BION-1301
BION-1301 Pre-Filled Syringe (PFS) 600mg subcutaneous administration every 2 weeks for 104 weeks.

Treatment: Drugs: Placebo
Placebo - PFS subcutaneous administration every 2 weeks for 104 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in eGFR
Timepoint [1] 0 0
Baseline and 104 weeks or approximately 2 years
Secondary outcome [1] 0 0
Change in proteinuria (natural log UPCR)
Timepoint [1] 0 0
Baseline and 40 weeks or approximately 9 months
Secondary outcome [2] 0 0
Annualized rate of change in eGFR
Timepoint [2] 0 0
104 weeks or approximately 2 years
Secondary outcome [3] 0 0
Effect of BION-1301 on specific clinical composite endpoints (30% eGFR reduction)
Timepoint [3] 0 0
Baseline and Weeks 4, 12, 24, 40, 52, 64, 76, 88, and 104
Secondary outcome [4] 0 0
Effect of BION-1301 on specific clinical composite endpoints (40% eGFR reduction)
Timepoint [4] 0 0
Baseline and Weeks 4, 12, 24, 40, 52, 64, 76, 88, and 104
Secondary outcome [5] 0 0
Percent Change in Proteinuria and Total Urine Protein
Timepoint [5] 0 0
40 weeks or approximately 9 months

Eligibility
Key inclusion criteria
* Male and female participants aged = 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
* Biopsy-proven IgAN diagnosed within the past 10 years prior to Screening, that, in the opinion of the Investigator, is not due to secondary causes. A pseudonymized copy of the report must be available for review by the Sponsor or designee prior to randomization. If biopsy report within 10 years is not available, re-biopsy may be permitted upon discussion with the Sponsor.
* eGFR = 30 mL/min/1.73m^2 at Screening based on the 2021 CKD-EPI equation.
* Total urine protein = 1.0 g/day or UPCR = 0.7 g/g (700 mg/g), as measured from an adequate 24-hour urine collection at Screening by a central laboratory.
* Stable on a maximally tolerated dose of angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin II receptor blockers (ARB) for at least 12 weeks prior to Screening unless intolerant to ACEi and ARB. May also be on a stable and well tolerated dose of sodium glucose cotransporter-2 inhibitors (SGLT2i), endothelin receptor antagonists (ERAs) and/or mineralocorticoid receptor antagonists (MRAs) for at least 12 weeks prior to Screening for the treatment of IgAN. Subjects are expected to stay on a stable dose of ACEi, ARB, SGLT2i, ERAs, and/or MRAs for the duration of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
* Secondary forms of IgAN as determined by the Investigator, in the setting of systemic disorders, infections, autoimmune disorders or neoplasias.
* Diagnosis of IgA Vasculitis.
* Current or history of nephrotic syndrome.
* Received systemic corticosteroid therapy including budesonide (Tarpeyo/Kinpeygo) for > 14 days within 12 weeks prior to Screening.
* Use of systemic immunosuppressant medications.
* IgG levels < 6 g/L at Screening.

Other protocol-defined inclusion/exclusion criteria may apply

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/01/2028
Actual
Sample size
Target
Accrual to date
Final
383
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Gosford
Recruitment hospital [2] 0 0
Novartis Investigative Site - Kogarah
Recruitment hospital [3] 0 0
Novartis Investigative Site - Liverpool
Recruitment hospital [4] 0 0
Novartis Investigative Site - Penrith
Recruitment hospital [5] 0 0
Novartis Investigative Site - St Leonards
Recruitment hospital [6] 0 0
Novartis Investigative Site - Cairns North
Recruitment hospital [7] 0 0
Novartis Investigative Site - Box Hill
Recruitment hospital [8] 0 0
Novartis Investigative Site - St Albans
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2750 - Penrith
Recruitment postcode(s) [5] 0 0
2065 - St Leonards
Recruitment postcode(s) [6] 0 0
4870 - Cairns North
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
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
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Argentina
State/province [18] 0 0
Buenos Aires
Country [19] 0 0
Argentina
State/province [19] 0 0
Catamarca Province
Country [20] 0 0
Argentina
State/province [20] 0 0
Ciudad Autónoma de BuenosAires
Country [21] 0 0
Argentina
State/province [21] 0 0
Santa Fe Province
Country [22] 0 0
Belgium
State/province [22] 0 0
Antwerpen
Country [23] 0 0
Belgium
State/province [23] 0 0
Oost-Vlaanderen
Country [24] 0 0
Belgium
State/province [24] 0 0
West-Vlaanderen
Country [25] 0 0
Belgium
State/province [25] 0 0
Liège
Country [26] 0 0
Belgium
State/province [26] 0 0
Lodelinsart
Country [27] 0 0
Belgium
State/province [27] 0 0
Woluwe-Saint-Lambert
Country [28] 0 0
Brazil
State/province [28] 0 0
Amapá
Country [29] 0 0
Brazil
State/province [29] 0 0
Minas Gerais
Country [30] 0 0
Brazil
State/province [30] 0 0
Paraná
Country [31] 0 0
Brazil
State/province [31] 0 0
Rio Grande do Sul
Country [32] 0 0
Brazil
State/province [32] 0 0
Santa Catarina
Country [33] 0 0
Brazil
State/province [33] 0 0
São Paulo
Country [34] 0 0
Canada
State/province [34] 0 0
British Columbia
Country [35] 0 0
Canada
State/province [35] 0 0
Ontario
Country [36] 0 0
Canada
State/province [36] 0 0
Quebec
Country [37] 0 0
China
State/province [37] 0 0
Anhui
Country [38] 0 0
China
State/province [38] 0 0
Beijing Municipality
Country [39] 0 0
China
State/province [39] 0 0
Guangdong
Country [40] 0 0
China
State/province [40] 0 0
Guangxi
Country [41] 0 0
China
State/province [41] 0 0
Guizhou
Country [42] 0 0
China
State/province [42] 0 0
Hubei
Country [43] 0 0
China
State/province [43] 0 0
Jiangsu
Country [44] 0 0
China
State/province [44] 0 0
Jiangxi
Country [45] 0 0
China
State/province [45] 0 0
Shandong
Country [46] 0 0
China
State/province [46] 0 0
Shanghai Municipality
Country [47] 0 0
China
State/province [47] 0 0
Shanxi
Country [48] 0 0
China
State/province [48] 0 0
Sichuan
Country [49] 0 0
China
State/province [49] 0 0
Xinjiang
Country [50] 0 0
China
State/province [50] 0 0
Zhejiang
Country [51] 0 0
Croatia
State/province [51] 0 0
City of Zagreb
Country [52] 0 0
Croatia
State/province [52] 0 0
Biškupec Zelinski
Country [53] 0 0
Croatia
State/province [53] 0 0
Rijeka
Country [54] 0 0
Croatia
State/province [54] 0 0
Vinkovci
Country [55] 0 0
Czechia
State/province [55] 0 0
Praha, Hlavní Mesto
Country [56] 0 0
France
State/province [56] 0 0
Gard
Country [57] 0 0
France
State/province [57] 0 0
Nord
Country [58] 0 0
France
State/province [58] 0 0
Rhône
Country [59] 0 0
France
State/province [59] 0 0
Grenoble
Country [60] 0 0
France
State/province [60] 0 0
Paris
Country [61] 0 0
Germany
State/province [61] 0 0
Bavaria
Country [62] 0 0
Germany
State/province [62] 0 0
Lower Saxony
Country [63] 0 0
Germany
State/province [63] 0 0
Rhineland-Palatinate
Country [64] 0 0
Germany
State/province [64] 0 0
Saxony-Anhalt
Country [65] 0 0
Germany
State/province [65] 0 0
Thuringia
Country [66] 0 0
Germany
State/province [66] 0 0
Essen
Country [67] 0 0
Greece
State/province [67] 0 0
Achaïa
Country [68] 0 0
Greece
State/province [68] 0 0
Attica
Country [69] 0 0
Greece
State/province [69] 0 0
Thessaloniki
Country [70] 0 0
Greece
State/province [70] 0 0
Heralkion
Country [71] 0 0
Greece
State/province [71] 0 0
Ioannina
Country [72] 0 0
India
State/province [72] 0 0
Andhra Pradesh
Country [73] 0 0
India
State/province [73] 0 0
Chandigarh
Country [74] 0 0
India
State/province [74] 0 0
Haryana
Country [75] 0 0
India
State/province [75] 0 0
Karnataka
Country [76] 0 0
India
State/province [76] 0 0
Kerala
Country [77] 0 0
India
State/province [77] 0 0
Rajasthan
Country [78] 0 0
India
State/province [78] 0 0
Tamil Nadu
Country [79] 0 0
India
State/province [79] 0 0
Uttar Pradesh
Country [80] 0 0
India
State/province [80] 0 0
West Bengal
Country [81] 0 0
India
State/province [81] 0 0
Dehradun
Country [82] 0 0
Israel
State/province [82] 0 0
Southern District
Country [83] 0 0
Israel
State/province [83] 0 0
Tel Aviv
Country [84] 0 0
Israel
State/province [84] 0 0
Be’er Ya‘aqov
Country [85] 0 0
Israel
State/province [85] 0 0
Ramat Gan
Country [86] 0 0
Italy
State/province [86] 0 0
Apulia
Country [87] 0 0
Italy
State/province [87] 0 0
Campania
Country [88] 0 0
Italy
State/province [88] 0 0
Emilia-Romagna
Country [89] 0 0
Italy
State/province [89] 0 0
Friuli Venezia Giulia
Country [90] 0 0
Italy
State/province [90] 0 0
Lombardy
Country [91] 0 0
Japan
State/province [91] 0 0
Aiti
Country [92] 0 0
Japan
State/province [92] 0 0
Chiba
Country [93] 0 0
Japan
State/province [93] 0 0
Hokkaidô
Country [94] 0 0
Japan
State/province [94] 0 0
Hukuoka
Country [95] 0 0
Japan
State/province [95] 0 0
Kanagawa
Country [96] 0 0
Japan
State/province [96] 0 0
Nara
Country [97] 0 0
Japan
State/province [97] 0 0
Osaka
Country [98] 0 0
Japan
State/province [98] 0 0
Tokyo
Country [99] 0 0
Japan
State/province [99] 0 0
Niigata
Country [100] 0 0
Japan
State/province [100] 0 0
Okayama
Country [101] 0 0
Japan
State/province [101] 0 0
Ôita
Country [102] 0 0
Malaysia
State/province [102] 0 0
Pahang
Country [103] 0 0
Malaysia
State/province [103] 0 0
Sarawak
Country [104] 0 0
Malaysia
State/province [104] 0 0
Selangor
Country [105] 0 0
Malaysia
State/province [105] 0 0
WilayahPersekutuan KualaLumpur
Country [106] 0 0
Mexico
State/province [106] 0 0
Chiapas
Country [107] 0 0
Mexico
State/province [107] 0 0
Mexico City
Country [108] 0 0
Mexico
State/province [108] 0 0
Aguascalientes
Country [109] 0 0
Mexico
State/province [109] 0 0
Chihuahua City
Country [110] 0 0
Mexico
State/province [110] 0 0
Monterrey
Country [111] 0 0
South Korea
State/province [111] 0 0
Gyeonggido
Country [112] 0 0
South Korea
State/province [112] 0 0
Seoul Teugbyeolsi
Country [113] 0 0
South Korea
State/province [113] 0 0
Cheonan
Country [114] 0 0
South Korea
State/province [114] 0 0
Daejeon
Country [115] 0 0
South Korea
State/province [115] 0 0
Seoul
Country [116] 0 0
Spain
State/province [116] 0 0
Valencia
Country [117] 0 0
Spain
State/province [117] 0 0
Barcelona
Country [118] 0 0
Spain
State/province [118] 0 0
Girona
Country [119] 0 0
Spain
State/province [119] 0 0
Lleida
Country [120] 0 0
Spain
State/province [120] 0 0
Lugo
Country [121] 0 0
Spain
State/province [121] 0 0
Madrid
Country [122] 0 0
Spain
State/province [122] 0 0
Seville
Country [123] 0 0
Taiwan
State/province [123] 0 0
Keelung
Country [124] 0 0
Taiwan
State/province [124] 0 0
Changhua County
Country [125] 0 0
Taiwan
State/province [125] 0 0
Hsinchu
Country [126] 0 0
Taiwan
State/province [126] 0 0
Hualien City
Country [127] 0 0
Taiwan
State/province [127] 0 0
Kaohsiung City
Country [128] 0 0
Taiwan
State/province [128] 0 0
Tainan
Country [129] 0 0
Taiwan
State/province [129] 0 0
Taipei
Country [130] 0 0
Turkey (Türkiye)
State/province [130] 0 0
Izmir
Country [131] 0 0
Turkey (Türkiye)
State/province [131] 0 0
Kocaeli
Country [132] 0 0
Turkey (Türkiye)
State/province [132] 0 0
Antalya
Country [133] 0 0
Turkey (Türkiye)
State/province [133] 0 0
Kayseri
Country [134] 0 0
United Kingdom
State/province [134] 0 0
Bristol, City of
Country [135] 0 0
United Kingdom
State/province [135] 0 0
East Sussex
Country [136] 0 0
United Kingdom
State/province [136] 0 0
Lancashire
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Leicestershire
Country [138] 0 0
United Kingdom
State/province [138] 0 0
London, City of
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Nottinghamshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
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?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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/NCT05852938