RecruitingPHASE3INTERVENTIONAL

Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN

This study is a long-term follow-up for people with rare kidney conditions called C3 Glomerulopathy (C3G) or Immune-complex-membranoproliferative Glomerulonephritis (IC-MPGN). It aims to understand how safe and effective a new medicine, iptacopan, is over a longer period. Participants are those who have already completed an earlier study with this medicine. The results from this long-term study will help health authorities decide if iptacopan can be approved for wider use. It will also allow patients who are already benefiting from the medicine to continue receiving it while it's not yet available in pharmacies. The study will continue for several years until the medicine is widely available.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Novartis Pharmaceuticals

Enrolment target

225

Start

03 Oct 2019

Estimated completion

30 May 2036

C3 Glomerulopathy Immune-complex-membranoproliferative Glomerulonephritis

What is this study about?

This research is looking into a new medicine called iptacopan, which is for people who have certain rare kidney conditions. These conditions are called C3 Glomerulopathy (we'll call it C3G) and Immune-complex-membranoproliferative Glomerulonephritis (IC-MPGN). These diseases can cause serious damage to the kidneys over time.

The main goal of this particular study is to keep a close eye on people who have already been taking iptacopan in a previous study. We want to see how well the medicine continues to work for them over a longer period, and also make sure it remains safe. Understanding these long-term effects is very important for doctors and patients.

The information gathered from this study, combined with what was learned before, will be given to health organisations, like those deciding which medicines can be used in the UK. This will help them make an informed decision about whether iptacopan can become a widely available treatment for C3G and IC-MPGN. It also means that patients who are currently finding the medicine helpful can continue to receive it until it's available in pharmacies.

Key takeaways

This study is for people already taking iptacopan for rare kidney diseases.
It aims to check the medicine's long-term safety and how well it works.
Results will help health authorities decide on wider approval for iptacopan.
Participants can continue receiving the medicine while it's not widely available.
The study involves regular health checks and could last several years.

Who may be eligible?

To join this study, you must have already taken part in and finished one of the previous studies involving iptacopan for C3G or IC-MPGN. You would have been taking the study medicine (iptacopan) until the end of that earlier study.

There are also some reasons why you might not be able to join. For example, if you have other serious health problems, such as severe heart or lung conditions, or a serious infection that isn't under control. You also can't join if you have a history of HIV or other immune system problems.

Your study doctor will carefully review your health and check for any other reasons from the study rules that might prevent you from taking part, to make sure it's safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have you already completed a previous study with iptacopan?
Are you currently free from severe heart or lung conditions?
Do you currently have an active serious infection like a bad cold or flu?
Do you have a history of HIV or other immune system problems?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll continue to take the study medicine, iptacopan. You will have regular visits to the clinic, where the study team will carry out health checks. These checks might include blood tests, urine tests, and looking at how your kidneys are working, to make sure the medicine is still effective and safe for you.

Over time, the study team will monitor your progress and how you are feeling. This study is designed to be quite long-term, potentially lasting for several years. It will continue until the medicine becomes widely available in pharmacies, or if it is decided for other reasons that the study should end. You will always be fully informed about what each visit involves and how long you are expected to participate.

Potential risks and benefits

Participating in this study might offer the benefit of continuing to receive iptacopan, which could help manage your kidney condition, especially if you felt better during the previous study. However, as with any medicine, there are potential risks, including side effects that may occur over a longer period. The study team will closely monitor your health to identify and manage any problems. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (50)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Childrens Hospital Colorado
Verified postcode
Aurora, United States· Recruiting
Georgia Nephrology Research Inst
Verified postcode
Lawrenceville, United States· Recruiting
University of Iowa Health Care
Verified postcode
Iowa City, United States· Recruiting
University of Minnesota
Verified postcode
Minneapolis, United States· Recruiting
Col Uni Med Center New York Presby
Verified postcode
New York, United States· Recruiting
Novartis Investigative Site
Unverified
CABA, Argentina· Recruiting
Novartis Investigative Site
Verified postcode
Buenos Aires, Argentina· Recruiting
Novartis Investigative Site
Verified postcode
Belo Horizonte, Brazil· Recruiting
Novartis Investigative Site
Verified postcode
Recife, Brazil· Recruiting
Novartis Investigative Site
Verified postcode
Porto Alegre, Brazil· Recruiting
Novartis Investigative Site
Verified postcode
Botucatu, Brazil· Recruiting
Novartis Investigative Site
Verified postcode
São Paulo, Brazil· Recruiting

Common questions

What is iptacopan?

Iptacopan is a new medicine being studied for rare kidney conditions like C3G and IC-MPGN.

Who can join this study?

Only people who have already finished taking part in an earlier study with iptacopan for C3G or IC-MPGN can join.

How long will the study last?

The study is expected to last for several years, continuing until the medicine is available in pharmacies.

What is the main goal of this study?

The main goal is to collect information on how safe and effective iptacopan is over a long time to help get it approved for wider use.

Will I keep seeing my regular doctor?

Yes, you should continue to see your regular doctor for your usual medical care while taking part in the study.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com 1-888-669-6682 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.