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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06564142




Registration number
NCT06564142
Ethics application status
Date submitted
19/08/2024
Date registered
21/08/2024

Titles & IDs
Public title
Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN)
Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Povetacicept in Adults With Immunoglobulin A Nephropathy (RAINIER)
Secondary ID [1] 0 0
2024-514135-17-00
Secondary ID [2] 0 0
VX24-AIS-D08
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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

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

Experimental: Povetacicept - Participants will be randomized to receive Povetacicept.

Placebo comparator: Placebo - Participants will be randomized to receive placebo matched to Povetacicept.


Treatment: Drugs: Povetacicept
Subcutaneous injection administration.

Treatment: Drugs: Placebo (matched to Povetacicept)
Placebo matched to Povetacicept subcutaneous injection administration.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR) at Week 36
Timepoint [1] 0 0
From Baseline at Week 36
Primary outcome [2] 0 0
Total Estimated Glomerular Filtration Rate (eGFR) Slope Through Week 104
Timepoint [2] 0 0
From Baseline Through Week 104
Secondary outcome [1] 0 0
Change From Baseline in eGFR at Week 104
Timepoint [1] 0 0
From Baseline at Week 104
Secondary outcome [2] 0 0
Time to Kidney Disease Progression Through Week 104
Timepoint [2] 0 0
From Baseline Through Week 104
Secondary outcome [3] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Score at Week 104
Timepoint [3] 0 0
From Baseline at Week 104

Eligibility
Key inclusion criteria
Key

* Diagnosed IgAN, with biopsy confirmation
* 24-hr proteinuria excretion =1.0 g/day or 24-hour uPCR =0.75 g/g
* Estimated glomerular filtration rate (eGFR) = 30 mL/min/1.73m^2
* Stable angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARBs) as per protocol specification

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have received any immunosuppressive treatment or procedures (including corticosteroids, oral immunosuppressive agents, B cell or plasma cell targeted therapies, complement targeted therapies, herbal medicines per protocol, and tonsillectomy) within a wash-out period per protocol
* Rapidly progressive glomerulonephritis with eGFR reduction >50% within 12 weeks of the start of 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 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
30/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2028
Actual
Sample size
Target
480
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Grampians Health Ballarat - Ballarat
Recruitment hospital [2] 0 0
Bendigo Hospital - Bendigo
Recruitment hospital [3] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [4] 0 0
Core Research Group Pty Ltd - Brisbane
Recruitment hospital [5] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [6] 0 0
Monash Health - Clayton
Recruitment hospital [7] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [8] 0 0
Renal Research Gosford - Gosford
Recruitment hospital [9] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [10] 0 0
Western Health (Sunshine Hospital) - Melbourne
Recruitment hospital [11] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [12] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [13] 0 0
Melbourne Renal Research - Reservoir
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- Ballarat
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- Bendigo
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- Birtinya
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- Brisbane
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- Camperdown
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- Clayton
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- Concord
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- Gosford
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- Heidelberg
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- Melbourne
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- Murdoch
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- Newcastle
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- Reservoir
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alpine Immune Sciences Inc, A Subsidiary of Vertex
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
Medical Information
Address 0 0
Country 0 0
Phone 0 0
617-341-6777
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT06564142