Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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29 July 2024 |
Main ID: |
EUCTR2020-001049-38-BE |
Date of registration:
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17/02/2021 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study of efficacy and safety of LNP023 in primary IgA nephropathy patients
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Scientific title:
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A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients |
Date of first enrolment:
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17/02/2021 |
Target sample size:
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470 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001049-38 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Belgium
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Brazil
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Canada
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Chile
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China
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Colombia
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Czech Republic
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Czechia
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Denmark
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Finland
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France
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Germany
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Hungary
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India
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Israel
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Italy
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Japan
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Korea, Republic of
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Malaysia
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Mexico
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Netherlands
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Norway
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Russian Federation
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Singapore
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Slovakia
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Slovenia
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South Africa
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Spain
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Sweden
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Taiwan
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Thailand
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Türkiye
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United Kingdom
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United States
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Viet Nam
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Contacts
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Contact type:
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Public
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Name:
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Clinical Trial Information Desk
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Address:
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Forum 1, Novartis Campus
4056
Basel
Switzerland |
Telephone:
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+41 61 324 1111 |
Email:
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clinicaltrial.enquiries@novartis.com |
Affiliation:
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Novartis Pharma AG |
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Contact type:
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Scientific
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Name:
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Clinical Trial Information Desk
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Address:
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Forum 1, Novartis Campus
4056
Basel
Switzerland |
Telephone:
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+41 61 324 1111 |
Email:
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clinicaltrial.enquiries@novartis.com |
Affiliation:
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Novartis Pharma AG |
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Key inclusion & exclusion criteria
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Inclusion criteria: •Male and female patients = 18 years of age with an eGFR level and biopsy-confirmed IgA nephropathy as follows: •For patients eGFR* = 45ml/min/1.73m2, a qualifying biopsy performed within the last 5 years is required. •For patients with eGFR* 30 to <45ml/min/1.73m2 a qualifying biopsy performed within 2 years with < 50% tubulointerstitial fibrosis is required. • For patients with eGFR* 20 to <30ml/min/1.73m2,a qualifying biopsy performed at any time. In all cases, if a historical biopsy is not available, one may be performed during screening. *eGFR calculated using the CKD-EPI formula (or modified MDRD formula according to specific ethnic groups and local practice guidelines) •Proteinuria due to primary diagnosis of IgA nephropathy as assessed at screening by UPCR =1 g/g (113 mg/mmol) sampled from FMV or 24h urine collection, as well as at the completion of the run-in period by UPCR =1 g/g (113 mg/mmol) calculated as the mean of two 24h urine collections obtained within 14 days of each other at baseline. •Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection is required prior to the start of study treatment. If the patient has not been previously vaccinated, or if a booster is required, vaccine should be given according to local regulations at least 2 weeks prior to first study drug administration. If study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated. •If not previously vaccinated, vaccination against Streptococcus pneumoniae and Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to first study drug administration. If study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated. •All patients must have been on supportive care including stable dose regimen of ACEi or ARB at either the locally approved maximal daily dose or the maximally tolerated dose (per investigators’ judgment) for at least 90 days before first study drug administration. In addition, if patients are taking diuretics or other antihypertensive therapy, or other background medication for IgAN, the doses should also be stabilized for at least 90 days prior to the first dosing of study treatment.
Other protocol-defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 456 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria: •Any secondary IgAN as defined by the investigator; secondary IgAN can be associated with cirrhosis, celiac disease, Human Immunodeficiency Virus (HIV) infection, herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, and inflammatory bowel disease, familial mediterranean fever, etc. •Sitting office SBP >140 mmHg or DBP >90 mmHg at the randomization visit • Patients previously treated with immunosuppressive or other immunmodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, hydroxychloroquine, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic corticosteroids exposure (>7.5 mg/d prednisone/prednisolone equivalent) within 90 days (or 180 days for rituximab) prior to first study drug administration. Participants previously or currently treated with oral budesonide. Participants treated with endothelin (receptor) antagonists within 90 days prior to first study drug administration. •Prior use of LNP023 or prior enrollment in any other LNP023 clinical trial where study drug was taken, including matching placebo •History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus and pneumococcus. •Active systemic bacterial, viral (including COVID-19) or fungal infection within 14 days prior to study drug administration.
Other protocol-defined exclusion criteria may apply.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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IgA Nephropathy MedDRA version: 27.0
Level: PT
Classification code 10021263
Term: IgA nephropathy
System Organ Class: 10038359 - Renal and urinary disorders
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Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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Intervention(s)
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Product Name: iptacopan Product Code: LNP023 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Iptacopan Current Sponsor code: LNP023 Other descriptive name: Iptacopan hydrochloride Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: For Interim Analysis: To evaluate the effect of LNP023 vs placebo on slowing eGFR decrease as measured by the change from baseline in eGFR; To assess the effect of LNP023 vs placebo on the proportion of study participants reaching proteinuria below 1g/g of UPCR; To evaluate the effect of LNP023 vs placebo on slowing IgAN progression measured by the annualized total slope of eGFR decline over 1 year; To assess the effect of LNP023 vs placebo on the change from baseline to 9 months in fatigue scale measured by the FACIT-Fatigue questionnaire For Final Analysis: To demonstrate the superiority of LNP023 vs placebo on delaying the time to first occurrence of a composite kidney failure endpoint; in the reduction of proteinuria at 9 months by measuring UPCR sampled from a 24h urine collection; on the proportion of study participants reaching proteinuria below 1g/g of UPCR at 9 months; on the change from baseline to 9 months
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Primary end point(s): Primary Endpoint for Interim Analysis: •Log-transformed ratio to baseline in UPCR (sampled from 24h urine collection) at 9 months Primary Endpoint for Final Analysis: •Annualized total eGFR slope estimated over 24 months.
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Main Objective: Main Objective for Interim Analysis: •To demonstrate superiority of LNP023 vs. placebo in the reduction of proteinuria at 9 months by measuring UPCR sampled from a 24h urine collection. Main Objective for Final Analysis: •To demonstrate superiority of LNP023 vs. placebo in slowing IgAN progression measured by the annualized total slope of eGFR decline over 24 months.
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Timepoint(s) of evaluation of this end point: For Interim Analysis: baseline and 9 months
For Final Analysis: baseline and 24 months
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Secondary Outcome(s)
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Secondary end point(s): Secondary Endpoint for Interim Analysis: •Change from baseline in eGFR at 9 months •Proportion of participants reaching UPCR (sampled from 24h urine collection) <1g/g at 9 months, without receiving CS/IS or other newly approved drugs or initiating new background therapy for treatment of IgAN or initiating Kidney Replacement Therapy (KRT). •Annualized total eGFR slope estimated over 12 months •Change from baseline to 9 months in the fatigue scale measured by the FACIT-Fatigue questionnaire •Safety endpoints (including adverse events/serious adverse events, safety laboratory parameters, vital signs) collected from baseline to 9 months. Secondary Endpoints for Final Analysis: •Time from randomization to first occurrence of composite kidney failure event, defined as reaching either sustained =30% decline in eGFR relative to baseline, or sustained eGFR <15 mL/min/1.73m², or maintenance dialysis, or receipt of kidney transplant, or death from kidney failure •Log-transformed ratio to baseline in UPCR (sampled from 24h urine collection) at 9 months •Proportion of participants reaching UPCR (sampled from 24h urine collection) <1g/g at 9 months without receiving CS/IS, or other newly approved drugs or initiating new background therapy for treatment of IgAN or initiating KRT •Change from baseline to 9 months in the fatigue scale measured by the FACIT-Fatigue questionnaire. •Safety endpoints (including adverse events/serious adverse events, safety laboratory parameters, vital signs) collected from baseline to the End of Study (EOS).
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Timepoint(s) of evaluation of this end point: For Interim Analysis: baseline and 9 months baseline and 9 months baseline and 12 months baseline and 9 months baseline and 9 months
For Final Analysis: up to 24 months 9 months baseline and 9 months baseline and 9 months baseline and EOS
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Secondary ID(s)
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2020-001049-38-HU
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CLNP023A2301
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Source(s) of Monetary Support
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Novartis Pharma AG
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Ethics review
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Status: |
Approved
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Approval date: |
08/02/2021
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Contact name: |
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Contact address: |
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Results
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Results available: |
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URL: |
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URL of the protocol: |
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Date Posted: |
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Date of completion: |
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Date of first publication: |
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Results summary: |
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Baseline characteristics: |
No results available |
Adverse events: |
No results available |
Outcome measures: |
No results available |
IPD sharing plan: |
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IPD sharing description: |
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