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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04557462




Registration number
NCT04557462
Ethics application status
Date submitted
15/09/2020
Date registered
21/09/2020

Titles & IDs
Public title
A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy
Scientific title
A Multicenter Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan in Adult Participants With Primary IgA Nephropathy Who Have Completed Study CLNP023X2203 or CLNP023A2301
Secondary ID [1] 0 0
2020-002200-40
Secondary ID [2] 0 0
CLNP023A2002B
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary IgA 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(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - LNP023

Experimental: LNP023 - All participants are receiving 200 mg b.i.d


Treatment: Drugs: LNP023
Capsule 200 mg (b.i.d.) taken orally twice a day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number and percentage of participants with serious adverse event
Assessment method [1] 0 0
Summary statistics on serious adverse events
Timepoint [1] 0 0
Date of first administration of (Day 1) to 7 days after the date of the last actual administration of study treatment
Primary outcome [2] 0 0
Number and percentage of participants with adverse event
Assessment method [2] 0 0
Summary statistics on adverse events
Timepoint [2] 0 0
Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Primary outcome [3] 0 0
Number and percentage of participants with adverse events of special interest
Assessment method [3] 0 0
Summary statistics on adverse events of special interest
Timepoint [3] 0 0
Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual adminstration of study treatment
Primary outcome [4] 0 0
Number and percentage of participants with abnormalities in vital signs
Assessment method [4] 0 0
Summary statistics on abnormalities in vital sign parameters
Timepoint [4] 0 0
Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Primary outcome [5] 0 0
Number and percentage of participants with abnormalities in ECG
Assessment method [5] 0 0
Summary statistics in abnormalities in ECG parameters
Timepoint [5] 0 0
Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Primary outcome [6] 0 0
Number and percentage of participants with abnormalities in clinical laboratory evaluations
Assessment method [6] 0 0
Summary statistics on abnormalities in clinical laboratory evaluations
Timepoint [6] 0 0
Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Secondary outcome [1] 0 0
Annualized total eGFR slope
Assessment method [1] 0 0
Annualized rate of renal disease progression as measured by mean eGFR slope at post baseline visits
Timepoint [1] 0 0
Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter
Secondary outcome [2] 0 0
Change from baseline in eGFR
Assessment method [2] 0 0
Average change from baseline in eGFR at post-baseline visits
Timepoint [2] 0 0
Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter
Secondary outcome [3] 0 0
Log transformed ratio to baseline in UPCR, UACR
Assessment method [3] 0 0
Log transformed ratio to baseline in UPCR, UACR at post-baseline visits. The log transformation refers to the natural log (base on e)
Timepoint [3] 0 0
Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter

Eligibility
Key inclusion criteria
* For LNP023X2203, participants must have completed part 1 or part 2 of the trial. For LNP023A2301, participants must have completed the entire core trial defined as the full 24 month treatment period.
* eGFR* = 20 ml/min/1.73m2

*eGFR calculated using the CKD-EPI formula (or modified MDRD formula according to specific ethnic groups and local practice guidelines)
* Per investigator's clinical judgement, the participant may benefit from receiving the open-label treatment of iptacopan 200 mg b.i.d.
* Prior Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections should be up to date (i.e. any boosters required administered according to local regulations.
* All participants must be on supportive care regimen of ACEi or ARB* as per KDIGO guidelines.

* participants who are not taking KDIGO guideline doses because they have documented allergies or intolerance to ACEi and ARB are eligible for the study
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* participants who screen or baseline failed in the CLNP023X2203 Part 1 or Part 2, or CLNP023A2301 studies or who prematurely withdrew from either study for any reason.
* Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with LNP023.
* Current (within 4 weeks of study drug administration in the REP) acute kidney injury (AKI)
* Presence of Rapidly Progressive Glomerulonephritis (RPGN) as defined by 50% decline in eGFR within the last 3 months.
* Participants treated with immunosuppressive or other immunmodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus and/or systemic corticosteroids exposure (>7.5 mg/d prednisone/prednisolone equivalent) within 5 half-lives of respective medication or 90 days prior to first study drug administration, whichever is shorter. Rituximab requires 180 days wash out.
* Use of other investigational drugs at the time of enrolment, or within 5 half-lives of enrolment or within 30 days whichever is longer.
* History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus and pneumococcus.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
20/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/11/2032
Actual
Sample size
Target
540
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment hospital [2] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [3] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3065 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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California
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Colorado
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Delaware
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Missouri
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Nevada
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Texas
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Argentina
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Ciudad Autonoma de Buenos Aire
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Cordoba
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Argentina
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Santa Fe
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Edegem
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Guang Zhou
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Qingdao
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Mersin
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Talas Kayseri
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United Kingdom
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Cambridge
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Leicester
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London
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Newcastle upon Tyne
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Salford
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Vietnam
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VNM

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 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
Email 0 0
novartis.email@novartis.com
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/NCT04557462