Study on the Effectiveness and Safety of Iptacopan for Patients with Primary IgA Nephropathy

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What is this study about?

This clinical trial is focused on studying a kidney disease called IgA Nephropathy, which affects the kidneys’ ability to filter waste from the blood. The study is testing a new treatment called Iptacopan, also known by its code name LNP023. This medication is taken in the form of hard gelatin capsules. The purpose of the study is to evaluate how effective and safe Iptacopan is for patients with IgA Nephropathy.

Participants in the study will be randomly assigned to receive either Iptacopan or a placebo, which looks like the medication but does not contain the active ingredient. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not biased. The study will last for a total of 24 months, with an interim analysis at 9 months to assess the initial effects of the treatment.

Throughout the study, participants will have regular check-ups to monitor their health and the progression of their kidney disease. The main focus will be on measuring protein levels in the urine, which is an indicator of kidney function, and observing any changes in kidney function over time. The study aims to determine if Iptacopan can reduce protein levels in the urine and slow down the progression of IgA Nephropathy compared to the placebo. Participants will also be monitored for any side effects or adverse reactions to the treatment.

1 joining the study

Upon joining the study, the patient will be randomly assigned to receive either the study medication, iptacopan, or a placebo. The placebo is a capsule that looks like the medication but does not contain the active substance.

The study is designed to be double-blind, meaning neither the patient nor the researchers will know which treatment the patient is receiving.

2 medication administration

The patient will take the assigned capsule orally. The dosage and frequency will be determined by the study protocol, which is not specified in the provided data.

The duration of the medication administration will be up to 24 months, depending on the patient’s progress and the study’s requirements.

3 monitoring and assessments

Throughout the study, the patient’s health will be monitored regularly. This includes collecting urine samples to measure protein levels and conducting blood tests to assess kidney function.

The primary goal is to evaluate the reduction of protein in the urine at 9 months and to monitor the progression of kidney function over 24 months.

4 safety evaluations

Safety assessments will be conducted to monitor any adverse effects or serious health events. This includes checking vital signs and laboratory parameters.

These evaluations will occur from the start of the study until 9 months and continue until the end of the study.

5 completion of the study

The study is expected to conclude by September 2025. At the end of the study, the collected data will be analyzed to determine the effectiveness and safety of the medication.

The final analysis will focus on the long-term impact on kidney function and the overall health outcomes for the patient.

Who Can Join the Study?

Must be a male or female who is 18 years of age or older.
Must have a confirmed diagnosis of IgA Nephropathy through a kidney biopsy.
Must have a certain level of kidney function, measured by eGFR (a test that shows how well your kidneys are working). The required eGFR levels depend on the time since the biopsy and the amount of kidney damage.
Must have proteinuria (a condition where there is too much protein in the urine) due to IgA Nephropathy, with specific levels measured during screening and at the start of the study.
Must be vaccinated against certain infections like Neisseria meningitidis and Streptococcus pneumoniae before starting the study treatment. If not previously vaccinated, the vaccine should be given at least 2 weeks before starting the study drug. If the study drug needs to start earlier, antibiotics should be used to prevent infection.
If not previously vaccinated, should receive a vaccine against Haemophilus influenzae infections, if available, at least 2 weeks before starting the study drug.
Must have been on supportive care, including a stable dose of medications like ACE inhibitors or ARBs (medications that help control blood pressure and protect the kidneys) for about 90 days before starting the study drug. If taking other medications for IgA Nephropathy, those doses should also be stable for about 90 days before starting the study treatment.

Who Cannot Join the Study?

Patients who are not diagnosed with IgA Nephropathy, a kidney condition.
Patients who are younger than 18 years old or older than 75 years old.
Patients who are not able to provide a 24-hour urine collection for testing.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have a history of drug or alcohol abuse.
Patients who have had a kidney transplant.
Patients who are unable to follow the study procedures or attend study visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Medizinische Hochschule Hannover	Hanover	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Hospital Universitario De Salamanca	Salamanca	Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Danderyds Sjukhus AB	Danderyd	Sweden
Region Oestergoetland	Linkoping	Sweden
Robert Bosch Krankenhaus GmbH	Stuttgart	Germany
Universitaetsklinikum Aachen AöR	Aachen	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
University Hospital Bratislava	Bratislava	Slovakia
Algemeen Ziekenhuis Delta	Roeselare	Belgium
UNIVERZITETNI KLINICNI CENTER MARIBOR	Maribor	Slovenia
Istituto Di Ricerche Farmacologiche Mario Negri	Ranica	Italy
University Of Debrecen	Debrecen	Hungary
Odense University Hospital	Odense	Denmark
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Karolinska University Hospital	Solna	Sweden
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
University Medical Center Ljubljana	Ljubljana	Slovenia
Rigshospitalet	Copenhagen	Denmark
University Of Pecs	Pecs	Hungary
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Hopital Beaujon	Clichy	France
University Of Szeged	Szeged	Hungary
Uxtlnqvfhexfxmzcqhqln Eyomv Alu	Essen	Germany
Uennugawnsti Msyggpb Cfncnau Gzbimrwjz	Groningen	The Netherlands
Fmc dkthpwsitk splurv sgxfnb	Kosice	Slovakia
Ajvnpsuyla Psistsgb Hlbyoinm Dv Mvkyeehtq	Marseille	France
Ucsoywnjxa Oo Agrkqee	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	03.12.2020
Czechia	Not recruiting	03.12.2020
Denmark	Not recruiting	03.12.2020
France	Not recruiting	03.12.2020
Germany	Not recruiting	03.12.2020
Hungary	Not recruiting	03.12.2020
Italy	Not recruiting	03.12.2020
Slovakia	Not recruiting	03.12.2020
Slovenia	Not recruiting	03.12.2020
Spain	Not recruiting	03.12.2020
Sweden	Not recruiting	03.12.2020
The Netherlands	Not recruiting	03.12.2020

Trial locations

Investigated drugs:

Iptacopan

LNP023 is a medication being studied for its potential to help patients with primary IgA nephropathy, a kidney disease. The trial aims to see if LNP023 can reduce the amount of protein in the urine, which is a sign of kidney damage, and slow down the progression of the disease over time.

Investigated diseases:

IgA nephropathy

IgA Nephropathy – IgA Nephropathy is a kidney disease that occurs when an antibody called immunoglobulin A (IgA) builds up in the kidneys, leading to inflammation. This inflammation can affect the kidneys’ ability to filter waste from the blood. Over time, the disease can cause the kidneys to leak blood and protein into the urine. The progression of IgA Nephropathy can vary, with some individuals experiencing slow progression over many years, while others may see a more rapid decline in kidney function. Symptoms may include blood in the urine, swelling in the hands and feet, and high blood pressure. The exact cause of IgA Nephropathy is not well understood, but it is believed to involve genetic and environmental factors.

Trial ID:

2024-511067-29-00

Protocol code:

CLNP023A2301

NCT ID:

NCT04578834

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Iptacopan for Patients with Primary IgA Nephropathy

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