Chronic kidney disease (C3 glomerulopathy)

Patients can be included in this study if they have the chronic kidney disease C3 glomerulopathy.

What is C3 glomerulopathy (C3G)?

Around 10% of the world population has a chronic kidney disease (CKD). Glomerulopathy is a form of chronic kidney disease. It occurs due to previous kidney diseases with a wide variety of causes. Many of these are characterised by inflammation and improper regulation of a part of the immune system, more specifically the complement system. As well as fighting the causes of disease, the complement system triggers a range of inflammatory reactions. We have found out that in many patients with kidney disease, the complement system is overactive. This can lead to permanent inflammatory reactions which harm the body. Improper regulation of the complement system can be congenital (present at birth), or it can be acquired, which means that the patient develops the disease over their life. Complement-drive renal diseases (CDRD) include C3 glomerulopathy (C3G), IgA nephropathy (IgAN) and membranous nephropathy (MN).

You can find further information for kidney disease patients on the website of the Bundesverband Niere e.V. – German Association for Kidney Diseases (bundesverband-niere.de) or the Self-help group for complement-driven diseases | MPGN und aHUS e.V. (ahus-selbsthilfe.de)

LNP023 (the study drug) blocks important steps in what is called the complement system. The complement system is an important component of the immune system which is supposed to protect the body from bacterial infections. If this part of the immune system is overactive, it can cause various kidney diseases, including C3G. The blocking effect of LNP023 on the complement system could therefore lead to a positive disease progression for C3G and relieve the associated symptoms.

    • LNP023 – the study drug: Currently undergoing clinical testing and not yet approved for the treatment of kidney diseases. It has been investigated in more than 200 patients in clinical studies so far. These patients include both healthy volunteers and more than 100 patients with different kidney diseases. LNP023 has not yet been marketed, which means that it cannot be received with a medical prescription or found in pharmacies.

    Currently (June 2021), no study results for LNP023 have been published. As soon as study results for the study drug LNP023 are available, you will be able to see them . Please type LNP023 in the search bar called „active substance“.

    Click here to learn more about the development of medicines as part of clinical studies.

During the first six months of study participation, study participants will receive either LNP023 or placebo, which is a medicine that does not contain any active substance. The treatment to be given during participation is decided randomly, like tossing a coin (this process is called randomisation). This means that, during the first six months of participation, the likelihood of receiving the study drug LNP023 is 50% (1:1 chance).

For the rest of the study, all participants receive the study drug; the probability is therefore 100%.

Details on how the medicine is to be given during this study are provided in the section „How is this study being conducted (study design)?“.

This study should find out whether LNP023 is safe, well tolerated, and effective in patients with C3 glomerulopathy. It also aims to find out whether the intake of LNP023 can improve kidney function.

The study is divided into the following sections:

  • Initial examination: It will be checked in detail whether the study is suitable for the given patient. This phase will last for two weeks.
  • Pre-treatment phase: If all of the conditions for participation have been met, patients will be included in the pre-treatment phase. During this phase, any additional necessary vaccinations will be given and a kidney biopsy will be performed. This phase will last up to 10 weeks.
  • Treatment phase: For the first six months of this phase, patients will be randomly assigned to two treatment groups:
    • Group 1: receives the study drug
    • Group 2: receives a fake medicine (placebo)

Patients will take a capsule containing the ingredient corresponding to their group at home twice daily at intervals of 12 hours. If it is necessary for medical reasons, the study doctor can find out which medicine was taken.
From the 7th month of the treatment phase, all participants will receive study drug LNP023. The medicine continues to be taken as capsules twice daily at intervals of 12 hours. At the start of this part of the treatment phase, a kidney biopsy is performed at the study site.
The use of medicines that patients were already taking to treat their disease will be continued as background therapy at the maximum tolerated dose throughout the entire duration of participation in this study following a discussion with the study doctor.
Information on the likelihood of study participants receiving the study drug can be found under „What is the likelihood of receiving the study drug?“.
All treatment appointments (visits) are conducted at the study site.

  • Follow-up phase: The health condition of study participants will continue to be monitored without any more medicine being given.

In the general part of this website, you can find a lot more information about study participation. You can also find responses to the FAQs and find out what is expected of participants in clinical studies.

Participants will take part in the study for around 15 months and will be asked to come to the study site at regular intervals. A total of 12 visits are planned. Further visits may be necessary if the study doctor or the participant request them. During the study, a total of two, or optionally three, kidney biopsies will be conducted.

The following rule applies to almost all clinical studies: female study participants and female partners of male study participants must not become pregnant and must use a reliable method of contraception.

Why is this so important? An unborn child is extremely sensitive during its development in its mother’s belly. Medicines can harm an unborn child. Medicines can also damage the sperm and therefore cause harm when a child is conceived.

As the health of the unborn child cannot be guaranteed if either the father or the mother is taking a study drug, pregnancy must not occur during study participation.

A reliable form of contraception is therefore a condition for participation in the study. Pregnant or breast-feeding women and women who are planning to have a baby must not take part in clinical studies for their own protection.

For this study, the following methods of contraception are permitted:

  • Complete abstinence (no sexual intercourse at all) for the entire duration of the study
  • Hormonal contraception such as the pill, a 3-monthly injection, or a vaginal ring
  • Coil (copper or hormonal)
  • A barrier method such as a condom, cervical cap or IUD
  • Sterilisation (if this has already occurred) of the woman or her partner

You can read more information about this here.

Participation in this study is open to adults

  • from 18 years
  • with C3 glomerulopathy confirmed by a biopsy.

Participation is not possible for patients who

  • are already taking part in another study
  • are not using reliable contraception
  • are pregnant or breast-feeding.

A study doctor from a study site will provide information about the exact requirements for participation, the procedures, the significance, the risks, and the scope of the study. Participation in the study is possible only if the study participants have given their voluntary consent to this. However, it is the study doctor who will decide from a medical point of view whether a patient can take part in a clinical study. The doctor will make this decision using all of the medical requirements that were decided on for the study in question.

After the end of the study, patients have various possibilities which they should talk about with the study doctor at the earliest occasion. Patients can also switch to a C3G open-label extension study and continue taking LNP023.

You can read more information about this here.

You will incur no additional costs because of your participation in this clinical trial.

You will receive compensation for travel, as well as compensation for the time that you provide for some of the investigations.

You can find further responses to the most frequently asked questions about study participation here.

The study is being performed at the study sites listed below. By clicking on the button „Contact study site“, you can write to the selected study site. An employee of the study site will then get in contact with you soon. You yourself decide whether you would prefer to be contacted by phone or by e-mail. Novartis cannot access or view the data for this contact.

After the first contact through the website, the next steps are usually:

  • A short telephone call with the study site: There will be a brief preliminary check as to whether the study could be suitable for you based on questions about your medical history. If, after the call, you are interested in taking part, the following step is
  • An appointment for the first discussion at the study site: You will be given all of the details on the study and can discuss all of your questions with the study doctor.

Your first questions, discussions, and appointments do not oblige you to take part in the study. Taking part in a study is always absolutely voluntary and requires written consent. To find out exactly what is required for study participation, click here.

If, during the contact phase or later on, you are no longer interested in taking part in the study, you can simply tell the study staff. This is no problem and you do not need to explain yourself.

Appointments involve a lot of effort for trial sites. Please reliably attend them, or cancel them with enough notice (at least 48 hours beforehand). You do not need to justify your cancellation.

The point of contact for this study is always the study doctor at the study site closest to you (see the list below).

General questions about the study can also be answered by the Novartis Medical InfoService (see below for contact details).

However, please note: Novartis, as the Sponsor of the study, is legally not allowed to give patients advice on clinical studies; it can provide only general information, such as the study procedure or place of conduct. All questions going beyond this can be answered only by the study doctor. To find out more about the people involved in the study and their responsibilities, click here.

Novartis Medical InfoService
Study code: „APPEAR-C3G“
Roonstraße 25, 90429 Nürnberg [Germany]
Tel.: +49(0)8 00-54 55 000 (free from within Germany)
Available Monday-Friday, 8 a.m.-6 p.m. CET
E-mail: infoservice.novartis@novartis.com

Study sites near you

Here, you can find an overview of all current study sites.

If no sites close to you are listed, please contact the Novartis Medical InfoService (see „Whom can I contact if I have further questions?“), as there may be changes in the sites.

 

In diesem Postleitzahlen-Bereich steht kein Studienzentrum zur Verfügung. Sofern ein weiterer Anfahrtsweg für Sie keinen Hinderungsgrund darstellen sollte, prüfen Sie bitte die angrenzenden Postleitzahl-Bereiche.

In diesem Postleitzahlen-Bereich steht kein Studienzentrum zur Verfügung. Sofern ein weiterer Anfahrtsweg für Sie keinen Hinderungsgrund darstellen sollte, prüfen Sie bitte die angrenzenden Postleitzahl-Bereiche.

In diesem Postleitzahlen-Bereich steht kein Studienzentrum zur Verfügung. Sofern ein weiterer Anfahrtsweg für Sie keinen Hinderungsgrund darstellen sollte, prüfen Sie bitte die angrenzenden Postleitzahl-Bereiche.

In diesem Postleitzahlen-Bereich steht kein Studienzentrum zur Verfügung. Sofern ein weiterer Anfahrtsweg für Sie keinen Hinderungsgrund darstellen sollte, prüfen Sie bitte die angrenzenden Postleitzahl-Bereiche.

In diesem Postleitzahlen-Bereich steht kein Studienzentrum zur Verfügung. Sofern ein weiterer Anfahrtsweg für Sie keinen Hinderungsgrund darstellen sollte, prüfen Sie bitte die angrenzenden Postleitzahl-Bereiche.

 

Novartis Pharma AG is the Sponsor of the study.

The study has received a favourable opinion from the competent Ethics Committee and was approved by the competent authorities.

Diese Studie war nicht für Sie geeignet?

Studien anderer Auftraggeber (Sponsoren), für welche aktuell Patient*innen gesucht werden, sind im internationalen Studienregister clinicaltrials.gov aufgeführt. Aktuell sind dort keine Studien mit ähnlichen Teilnahmevoraussetzungen gelistet. Besuchen Sie clinicaltrials.gov, um eine eigene Studiensuche zu starten.

Bitte beachten Sie, dass es sich bei den Informationen um Angaben von einer öffentlich verfügbaren externen Webseite handelt. Für deren inhaltliche Richtigkeit und Vollständigkeit übernimmt Novartis keine Gewähr.

Um zurück zur Übersicht der von Novartis gesponsorten bzw. durchgeführten Studien zu gelangen, klicken Sie auf den unten stehenden Button.

Studien-Wecker

Lassen Sie sich benachrichtigen, wenn neue Informationen zu Ihrer Erkrankung online gehen.
Jetzt Anmelden