Long-term safety and effectiveness study of atacicept in patients with IgA nephropathy (IgAN)

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What is this study about?

This study focuses on patients with IgA Nephropathy (IgAN), a kidney disease that affects the filtering units of the kidneys. The study will test a medication called atacicept, which is given as an injection under the skin using either a pre-filled syringe or an auto-injector device. The purpose is to evaluate how safe and effective this medication is when used for a long time.

During the study, participants who previously completed treatment with atacicept in an earlier IgAN study will continue receiving the medication. The treatment will be given through subcutaneous (under the skin) injections, with doses up to 150 milligrams. The study medication will be provided in two forms: a ready-to-use pre-filled syringe or an auto-injector device for self-administration.

The study will monitor participants’ kidney function and overall health through regular medical check-ups and laboratory tests. The treatment period may last up to 156 weeks, during which doctors will track any side effects and measure how well the medication works by checking protein levels in urine and monitoring kidney function. Participants’ blood pressure and other health indicators will be regularly monitored throughout the study period.

1 Initial qualification

You will undergo initial qualification if you have completed previous treatment with atacicept in a parent study for IgAN (immunoglobulin A nephropathy).

Your blood pressure must be below 150/90 mmHg at screening and Day 1 (applicable for Drug Holiday Group).

Your kidney function will be assessed through eGFR test, which must be ≥20 mL/min/1.73 m² at screening (applicable for Drug Holiday Group).

2 Medical requirements verification

If you were assigned female at birth, a pregnancy test will be conducted – both serum test at screening and urine test on Day 1.

Your current medications will be reviewed to ensure you are on a stable dose of blood pressure medication (ACEi or ARB) if you are in the Drug Holiday Group.

3 Treatment administration

You will receive atacicept through subcutaneous injection (under the skin).

The medication will be provided either in a pre-filled syringe or autoinjector combination.

4 Monitoring and assessments

Your kidney function will be regularly monitored through urine and blood tests.

Tests will measure protein levels in urine (UPCR and UACR)

Your kidney filtering function (eGFR) will be assessed through blood tests measuring creatinine and cystatin C levels.

Urine tests will check for presence of blood (hematuria).

Blood tests will measure Gd-IgA1 levels.

5 Safety monitoring

Regular clinical and laboratory tests will be conducted to monitor your health.

Any side effects or adverse events will be recorded and monitored.

The study will continue until approximately April 2028.

Who Can Join the Study?

Must be able to understand and sign an informed consent form before starting any study procedures
Must have completed previous treatment with atacicept in a parent study for IgAN (a kidney disease)
For patients in the Drug Holiday Group:
- Blood pressure must be no higher than 150/90 mmHg at screening and first day
- Kidney function (eGFR) must be at least 20 mL/min/1.73 m2 at screening
- Must be taking stable doses of blood pressure medications (ACEi or ARB) at the maximum tolerated dose
For female participants:
- Must not be pregnant (confirmed by blood test at screening and urine test on day 1)
- Must not be breastfeeding for at least 3 months before screening
- Must either be unable to have children, or if able to have children, must use highly effective birth control (99% effective) from 7 days before study start until 175 days after last dose

Who Cannot Join the Study?

History of severe allergic reactions or anaphylaxis to biological agents
Active or chronic infections, including hepatitis B, hepatitis C, or HIV
History of cancer within the past 5 years (except treated non-melanoma skin cancer)
Severe kidney dysfunction (estimated glomerular filtration rate below 30 mL/min)
Uncontrolled high blood pressure (systolic >160 mmHg or diastolic >100 mmHg)
History of blood clotting disorders or significant bleeding events
Current treatment with other investigational drugs or participation in another clinical trial
Pregnant women or women planning pregnancy during the study period
Active liver disease or abnormal liver function tests
Significant heart conditions including heart failure or recent heart attack
History of organ transplantation
Current treatment with immunosuppressive medications (drugs that weaken the immune system)
Recent live vaccinations within 4 weeks before starting the study
History of substance abuse within the past year
Any condition that, in the investigator’s opinion, makes the patient unsuitable for the study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi	Lodz	Poland
4 Wojskowy SzpitaKliniczny Z Polikliniką Samodzielny Publiczny ZakładOpieki ZdrowotneWe Wrocławiu	Wroclaw	Poland
Technische Universitaet Dresden	Dresden	Germany
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Universitair Ziekenhuis Gent	Gent	Belgium
Algemeen Ziekenhuis Delta	Roeselare	Belgium
University General Hospital Of Heraklion	Heraklion	Greece
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
University General Hospital Of Ioannina	Ioannina	Greece
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ	Lodz	Poland
Hospital Clinic De Barcelona	Barcelona	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital Del Mar	Barcelona	Spain
Hospital Universitario Torrecardenas	Almeria	Spain
Gveeqw Njyqyqfzxt Ngckqph Ptdpanz Ajq Picmrrfmfgj Gphwxg Nbizlxbnje Douytgg Abpsqmc I	Νikaia	Greece
Lkiol Gbvlcia Hnymzbcl Ot Ajqgri	Athens	Greece
Pyqcxgvni Imukaesy Mfunsdzb Mprssaufholc Svbjh Wghleiotbmgc I Aepxqgmbvfcok	Warsaw	Poland
Kltovmtt dzg Urukzuviwytz Mkdqfctr Akr	Munich	Germany

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.02.2025
Czechia	Recruiting	01.02.2025
Germany	Recruiting	01.02.2025
Greece	Recruiting	01.02.2025
Poland	Recruiting	01.02.2025
Spain	Recruiting	01.02.2025

Trial locations

Investigated drugs:

Atacicept

Atacicept is a biological medication that works by targeting specific proteins in the immune system. It is designed to help regulate immune responses in the body. This medication is being studied for its long-term effects and safety in patients with autoimmune conditions. Atacicept is administered through injections and works by blocking certain molecules that contribute to inflammation and abnormal immune responses.

IgA Nephropathy (IgAN) – A kidney disease where abnormal IgA antibodies build up in the kidneys, causing inflammation and damage to kidney tissues. The disease occurs when these antibodies form deposits in the kidney’s filtering units called glomeruli. Over time, these deposits lead to inflammation, which can cause the kidneys to leak protein and blood into the urine. IgA Nephropathy typically progresses slowly, with symptoms such as blood in the urine, protein in the urine, and swelling in hands and feet. The condition can affect both children and adults, with varying degrees of severity.

Trial ID:

2024-516380-81-00

Protocol code:

VT-001-0051

Trial Phase:

Therapeutic exploratory (Phase II)

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Long-term safety and effectiveness study of atacicept in patients with IgA nephropathy (IgAN)

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