World Health Organization site
Skip Navigation Links

Please fill this short user satisfaction survey


Main
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: EUCTR
Last refreshed on: 29 July 2024
Main ID:  EUCTR2020-001049-38-BE
Date of registration: 17/02/2021
Prospective Registration: Yes
Primary sponsor: Novartis Pharma AG
Public title: Study of efficacy and safety of LNP023 in primary IgA nephropathy patients
Scientific title: 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: 17/02/2021
Target sample size: 470
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001049-38
Study type:  Interventional clinical trial of medicinal product
Study design:  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  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Argentina Australia Belgium Brazil Canada Chile China Colombia
Czech Republic Czechia Denmark Finland France Germany Hungary India
Israel Italy Japan Korea, Republic of Malaysia Mexico Netherlands Norway
Russian Federation Singapore Slovakia Slovenia South Africa Spain Sweden Taiwan
Thailand Türkiye United Kingdom United States Viet Nam
Contacts
Contact type: Public
Name: Clinical Trial Information Desk   
Address:  Forum 1, Novartis Campus 4056 Basel Switzerland
Telephone: +41 61 324 1111
Email: clinicaltrial.enquiries@novartis.com
Affiliation:  Novartis Pharma AG
Contact type: Scientific
Name: Clinical Trial Information Desk   
Address:  Forum 1, Novartis Campus 4056 Basel Switzerland
Telephone: +41 61 324 1111
Email: clinicaltrial.enquiries@novartis.com
Affiliation:  Novartis Pharma AG
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
IgA Nephropathy
MedDRA version: 27.0 Level: PT Classification code 10021263 Term: IgA nephropathy System Organ Class: 10038359 - Renal and urinary disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

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

Primary Outcome(s)
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
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.
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.
Timepoint(s) of evaluation of this end point: For Interim Analysis:
baseline and 9 months

For Final Analysis:
baseline and 24 months
Secondary Outcome(s)
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).
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
Secondary ID(s)
2020-001049-38-HU
CLNP023A2301
Source(s) of Monetary Support
Novartis Pharma AG
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 08/02/2021
Contact name:
Contact address:
Contact telephone:
Contact email:
Results
Results available:
URL:
URL of the protocol:
Date Posted:
Date of completion:
Date of first publication:
Results summary:
Baseline characteristics: No results available
Adverse events: No results available
Outcome measures: No results available
IPD sharing plan:
IPD sharing description:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history Please fill this short user satisfaction survey