Study on Imlifidase and Drug Combination for Treating Severe Goodpasture Disease in Patients

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What is this study about?

This clinical trial is focused on studying a rare condition known as Goodpasture disease, which is also referred to as anti-GBM antibody disease. This disease affects the kidneys and lungs, causing them to become inflamed and damaged. The trial aims to compare the effectiveness of a new treatment called imlifidase in combination with standard treatments, against standard treatments alone. The standard treatments include medications such as cyclophosphamide, prednisolone, methylprednisolone, trimethoprim, sulfamethoxazole, and loratadine. These medications are used to suppress the immune system, reduce inflammation, and prevent infections.

The purpose of the study is to determine if the combination of imlifidase and standard treatments can improve kidney function more effectively than standard treatments alone. Participants in the study will receive either the combination treatment or the standard treatment. The study will monitor the participants’ kidney function over a period of time to assess the effectiveness of the treatments. The trial will also look at other factors such as the time it takes for the disease-causing antibodies to reach non-toxic levels and the overall health status of the participants.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to track the progress of their kidney function. The study will last for several months, and participants will undergo regular check-ups and tests to evaluate their response to the treatment. The results of this trial could provide valuable insights into better treatment options for individuals suffering from Goodpasture disease.

1 randomization

Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the medication imlifidase along with standard care, while the other group will receive standard care alone. This process is random to ensure fairness and accuracy in the study results.

2 initial treatment

If you are in the group receiving imlifidase, you will be given this medication through an intravenous infusion. This means the medication will be delivered directly into your bloodstream through a vein. The dosage is 11 mg, and it will be administered as a single dose at the start of the treatment.

3 standard care

All participants will receive standard care, which includes medications such as methylprednisolone and prednisolone. These are steroids that help reduce inflammation. Methylprednisolone is given as an intravenous infusion, while prednisolone is taken orally. The specific dosage and frequency will be determined by the study doctors based on your individual needs.

You may also receive other medications like trimethoprim and sulfamethoxazole orally to prevent infections, and loratadine orally to manage any allergic reactions.

4 monitoring and follow-up

Throughout the study, your kidney function will be closely monitored. This includes regular blood tests to measure your estimated glomerular filtration rate (eGFR), which indicates how well your kidneys are working.

You will have follow-up visits at 3 months and 6 months to assess your kidney function and overall health. During these visits, the study team will check for any side effects and ensure that the treatment is working as intended.

5 end of study

At the end of the study, which lasts for approximately 6 months, a final assessment will be conducted. This will include a comprehensive evaluation of your kidney function and any other health parameters that were monitored during the study.

The results will help determine the effectiveness of imlifidase in combination with standard care compared to standard care alone in treating severe anti-GBM antibody disease.

Who Can Join the Study?

The patient must have a level of anti-GBM antibodies that is above a toxic level. These are specific proteins in the blood that can attack the kidneys.
The patient must have haematuria, which means blood in the urine, detectable by a urine test.
The patient must have an eGFR (estimated Glomerular Filtration Rate) of less than 20 mL/min/1.73 m². This is a measure of how well the kidneys are working.
The patient must be aged 18 years or older.
The patient must be willing and able to give written Informed Consent, which means they understand the study and agree to participate, and must be able to follow the study requirements.

Who Cannot Join the Study?

Patients with a history of severe allergic reactions to the study medication.
Patients who are currently pregnant or breastfeeding.
Patients with any other serious medical condition that might interfere with the study.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a history of drug or alcohol abuse.
Patients who are unable to follow the study procedures or instructions.
Patients with a known infection that could affect the study results.
Patients who have received an organ transplant.
Patients with a history of cancer within the last 5 years, except for certain skin cancers.
Patients with uncontrolled high blood pressure.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medical University Of Graz	Graz	Austria
Region Oestergoetland	Linkoping	Sweden
Medical University Of Vienna	Vienna	Austria
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi	Lodz	Poland
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Academisch Ziekenhuis Leiden	Leiden	The Netherlands
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	Poland
Hopital Tenon	Paris	France
Les Hopitaux Universitaires De Strasbourg	STRASBOURG, Alsace	France
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
Karolinska University Hospital	Solna	Sweden
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Centre Hospitalier Universitaire De Nantes	Nantes	France
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Rigshospitalet	Copenhagen	Denmark
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Universitaetsklinikum Aachen AöR	Aachen	Germany
Charite Research Organisation GmbH	Berlin	Germany
Universita Degli Studi Di Brescia	Brescia	Italy
Odense University Hospital	Odense	Denmark
Sadkjziog Riyltfb Ukadqecpjx Moahbjz Cshhqy	Nijmegen	The Netherlands
Cyc Dx Rmqfc	Bois-Guillaume	France
Utdmnfyxab Hjdenvrg Cojmzze	Cologne	Germany
Aevwoxrqtm Pyfnhaoy Hkpywmor Dp Mefkycyat	Marseille	France
Ugupkns Ulcrylihja Hgcxnxfh	Uppsala	Sweden
Avkihs Uuuyljklfz Htujdwjw	Aarhus	Denmark
Ktrhlosp dny Ufsnrorzteut Mvjjplcm Ane	Munich	Germany
Atnfudo Uufnq Sqkmttdqd Lokjzp Ds Bhdqkkc	Bologna	Italy
Uglrzftnfq Om Aqosobq	Edegem	Belgium
Umzqyhpxay Mbzpmut Cnajoj Hnjyeozxduremkgsc	Hamburg	Germany
Uxbckzqikxza Mlqdskl Cfrfpfe Gdhqkqhkm	Groningen	The Netherlands
Cryh Uvbwbmzkks Hhdviika	Cork	Ireland
Hkysgutr Vgfc dbclxjgu	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.01.2023
Belgium	Not recruiting	01.01.2023
Czechia	Not recruiting	01.01.2023
Denmark	Not recruiting	01.01.2023
France	Not recruiting	01.01.2023
Germany	Not recruiting	01.01.2023
Ireland	Not recruiting	01.01.2023
Italy	Not recruiting	01.01.2023
Poland	Not recruiting	01.01.2023
Spain	Not recruiting	01.01.2023
Sweden	Not recruiting	01.01.2023
The Netherlands	Not recruiting	01.01.2023

Trial locations

Investigated drugs:

Imlifidase is a medication being tested in this clinical trial for its potential to help people with a severe condition called anti-GBM antibody disease, also known as Goodpasture disease. This disease can cause serious damage to the kidneys. Imlifidase works by breaking down certain antibodies in the body that are responsible for attacking the kidneys. By doing this, it may help to protect the kidneys and improve their function.

Standard-of-Care (SoC) refers to the usual treatment that patients with Goodpasture disease receive. This can include a combination of medications and therapies that doctors typically use to manage the disease and its symptoms. The goal of standard-of-care is to control the disease and prevent further damage to the kidneys. In this trial, the standard-of-care is being compared to see if adding imlifidase provides better results for patients.

Anti-GBM antibody disease (Goodpasture disease) – This is an autoimmune disorder where the immune system mistakenly attacks the basement membrane in the lungs and kidneys. The disease often begins with respiratory symptoms such as coughing and shortness of breath, followed by kidney-related symptoms like blood in the urine and swelling. As the disease progresses, it can lead to inflammation and damage in the kidneys, potentially causing kidney failure. The presence of anti-GBM antibodies in the blood is a hallmark of this condition, leading to the destruction of kidney and lung tissues. Over time, the damage to these organs can become severe, affecting their ability to function properly. The disease requires careful monitoring to manage its progression and impact on the body.

Trial ID:

2022-500121-33-01

Protocol code:

21-HMedIdeS-24

NCT ID:

NCT05679401

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Imlifidase and Drug Combination for Treating Severe Goodpasture Disease in Patients

What is this study about?

Who Can Join the Study?

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