Study on Long-Term Effects of Iptacopan in Patients with C3 Glomerulopathy or Idiopathic Immune-Complex Membranoproliferative Glomerulonephritis

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What is this study about?

This clinical trial is focused on studying two kidney diseases: C3 Glomerulopathy and Idiopathic Immune-Complex Membranoproliferative Glomerulonephritis. These are conditions where the immune system affects the kidneys, leading to inflammation and potential damage. The treatment being tested in this study is a medication called Iptacopan, which is taken orally in the form of hard gelatin capsules. The purpose of the study is to evaluate the long-term effectiveness, safety, and tolerability of Iptacopan in individuals with these kidney diseases.

Participants in the study will receive Iptacopan over a period of time, with the maximum treatment period being 66 weeks. The study will monitor how well the medication works in managing the kidney conditions and will also keep track of any side effects or issues that may arise during the treatment. The study aims to provide valuable information on how Iptacopan can help in treating these specific kidney diseases.

Throughout the study, participants will have regular check-ups to assess their kidney function and overall health. This will include monitoring important health indicators and any changes in the condition of the kidneys. The study is designed to ensure that participants are closely observed to gather comprehensive data on the long-term use of Iptacopan for these kidney diseases.

1 joining the study

Upon joining the study, the participant must have completed the treatment period of a previous study, specifically CLNP023X2202, CLNP023B12301, or CLNP023B12302.

2 medication administration

The participant will take iptacopan hydrochloride in the form of hard gelatin capsules.

The medication is administered orally. The specific dosage and frequency will be determined by the study protocol.

3 initial assessment

An initial assessment will be conducted to establish baseline measurements for various health indicators, including kidney function and protein levels in urine.

4 ongoing monitoring

Throughout the study, regular monitoring of vital signs, heart rate, and laboratory measurements will occur.

The participant’s response to the medication will be evaluated, focusing on kidney function and protein levels in urine.

5 primary evaluation

At the 9-month mark, the primary evaluation will assess the effect of iptacopan on kidney function and protein levels in urine.

For participants with a transplanted kidney, the evaluation will focus on changes in C3 deposit scores.

6 long-term assessment

The study aims to evaluate the long-term safety and tolerability of iptacopan over an extended period.

Participants will continue to be monitored for any adverse effects or changes in health status.

7 study completion

The study is estimated to conclude by April 20, 2033.

Final assessments will be conducted to determine the overall efficacy and safety of the treatment.

Who Can Join the Study?

Participants must have completed the treatment period of the previous study, which could be one of the following: CLNP023X2202, CLNP023B12301, or CLNP023B12302. This means they should have finished the required treatment in these studies.
Participants can be of any gender, meaning both males and females are eligible to join the study.
The study is open to people who are considered part of a vulnerable population. This term refers to groups of people who might need special protection or care, such as children, elderly, or those with certain health conditions.
The age range for participants includes different categories, which means people of various ages can participate. The specific age groups are not detailed here, but they cover a wide range.

Who Cannot Join the Study?

Patients with a history of C3 Glomerulopathy or idiopathic immune-complex membranoproliferative glomerulonephritis cannot participate. These are specific kidney conditions where the immune system affects the kidneys.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not part of the specified clinical trial groups cannot participate. The study is designed for specific groups of patients.
Patients who are not male or female cannot participate. The study includes both male and female participants.
Patients who are considered part of a vulnerable population cannot participate. This refers to groups of people who might be at higher risk or need special protection.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Clinico San Carlos	Madrid	Spain
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Geniko Nosokomeio Thessalonikis George Papanikolaou	Thessaloniki	Greece
University General Hospital Of Heraklion	Heraklion	Greece
Ippokratio General Hospital Of Thessaloniki	Thessaloniki	Greece
Istituto Di Ricerche Farmacologiche Mario Negri	Ranica	Italy
Hippokration Hospital	Athens	Greece
University General Hospital Of Thessaloniki Ahepa	Thessaloniki	Greece
University General Hospital Of Ioannina	Ioannina	Greece
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
General University Hospital Of Patras	Patras	Greece
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Centre Hospitalier Universitaire De Rennes	Rennes	France
Hopital Beaujon	Clichy	France
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara	Chaidari	Greece
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari	Bari	Italy
Ufsynahzau Mwykswp Cvunci Hwzyrbjdokhacnsdk	Hamburg	Germany
Ufjyezsgueifvlgwfkcpf Epzus Agx	Essen	Germany
Lpnek Uylncpqzwdtl Mhucjxm Cznltob (ymaaz	Leiden	The Netherlands
Syplzdtvv Rmesqtc Uynbcixego Mtxlxev Cbfaej	Nijmegen	The Netherlands
Hipyywkj Vvct dlcckkux	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	30.10.2019
France	Recruiting	30.10.2019
Germany	Recruiting	30.10.2019
Greece	Recruiting	30.10.2019
Italy	Recruiting	30.10.2019
Spain	Recruiting	30.10.2019
The Netherlands	Recruiting	30.10.2019

Trial locations

Investigated drugs:

Iptacopan is a medication being studied for its potential to help people with certain kidney conditions, specifically C3 glomerulopathy (C3G) and idiopathic immune-complex-membranoproliferative glomerulonephritis (IC-MPGN). The trial aims to see how well iptacopan works over a long period, focusing on its ability to improve kidney function and reduce harmful deposits in the kidneys. The study also looks at how safe and tolerable the medication is for patients over time.

C3 Glomerulopathy – This is a rare kidney disease characterized by the abnormal accumulation of C3 protein in the glomeruli, which are tiny filters in the kidneys. The disease can lead to inflammation and damage to these filters, affecting their ability to properly filter waste from the blood. Over time, this can result in proteinuria, where excess protein is found in the urine, and a decline in kidney function. The progression of the disease can vary, with some individuals experiencing a slow decline in kidney function, while others may have a more rapid progression. The exact cause of C3 glomerulopathy is not fully understood, but it is believed to involve genetic and immune system factors. Regular monitoring of kidney function and protein levels in urine is important for managing the condition.

Idiopathic Immune-Complex Membranoproliferative Glomerulonephritis – This is a kidney disorder characterized by the buildup of immune complexes in the glomeruli, leading to inflammation and thickening of the glomerular basement membrane. The condition can cause the kidneys to become less effective at filtering waste from the blood, resulting in symptoms such as blood in the urine, proteinuria, and swelling in various parts of the body. The progression of the disease can vary, with some individuals experiencing a gradual decline in kidney function, while others may have a more rapid progression. The exact cause of the disease is unknown, but it is thought to involve an abnormal immune response. Regular monitoring of kidney function and urine protein levels is crucial for managing the condition.

Trial ID:

2023-509343-27-00

Protocol code:

CLNP023B12001B

NCT ID:

NCT03955445

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Long-Term Effects of Iptacopan in Patients with C3 Glomerulopathy or Idiopathic Immune-Complex Membranoproliferative Glomerulonephritis

What is this study about?

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