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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
23/12/2030
Actual
Sample size
Target
510
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
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Research Site - Camperdown
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Research Site - Canberra
Recruitment hospital [3] 0 0
Research Site - Clayton
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Research Site - Parkville
Recruitment hospital [8] 0 0
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Research Site - Southport
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Research Site - St Albans
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2050 - Camperdown
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2605 - Canberra
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3168 - Clayton
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2139 - Concord
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4029 - Herston
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2170 - Liverpool
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3050 - Parkville
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6000 - Perth
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4222 - Southport
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3021 - St Albans
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Spain
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Bangkok
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Chaingmai
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Khlong Luang
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Khon Kaen
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Bursa
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Kayseri
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Dundee
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Leicester
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London
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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
clinicaltrials@alexion.com
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