Study on the Effects of Atacicept in Adults with IgA Nephropathy

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What is this study about?

This clinical trial is focused on studying a kidney disease called IgA Nephropathy (IgAN). The study is testing a treatment called Atacicept, which is given as an injection under the skin using a pre-filled syringe. Atacicept is a protein-based medication developed by Vera Therapeutics Inc. The trial also involves a comparison with a placebo, which is a substance with no active medication. Additionally, some participants may be taking other medications like Enalapril or Losartan, which are commonly used to manage blood pressure and kidney conditions.

The purpose of this study is to evaluate how effective Atacicept is in reducing protein levels in the urine of adults with IgA Nephropathy. Protein in the urine, known as proteinuria, is a sign of kidney damage. The study is designed to be randomized and double-blinded, meaning neither the participants nor the researchers know who is receiving Atacicept or the placebo. This helps ensure the results are unbiased. The study will take place over several weeks, with regular check-ups to monitor the participants’ health and the effects of the treatment.

Participants will receive Atacicept or a placebo through subcutaneous injections, which means the medication is injected just under the skin. The study will also monitor the participants’ kidney function and overall health throughout the trial. By the end of the study, researchers hope to determine if Atacicept is a safe and effective treatment option for people with IgA Nephropathy.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, you will receive detailed information about the study and what to expect. You will be asked to sign a consent form, confirming your understanding and willingness to participate.

A series of assessments will be conducted to confirm your eligibility. These assessments may include a review of your medical history, a physical examination, and laboratory tests.

2 randomization

Once eligibility is confirmed, you will be randomly assigned to one of the study groups. This means you may receive either the study medication, atacicept, or a placebo, which looks like the medication but does not contain the active ingredient.

The assignment is random and neither you nor the study team will know which group you are in. This is to ensure the study results are unbiased.

3 medication administration

If you are assigned to receive atacicept, it will be administered as a subcutaneous injection, which means it is injected under the skin. The dosage and frequency will be explained to you by the study team.

If you are in the placebo group, you will receive injections that do not contain the active medication. The schedule for these injections will be the same as for those receiving atacicept.

4 regular follow-up visits

Throughout the study, you will have regular follow-up visits. These visits are important to monitor your health and the effects of the treatment.

During these visits, you may undergo various tests, such as blood tests and urine tests, to assess your response to the treatment and to check for any side effects.

5 end of treatment

At the end of the treatment period, you will have a final visit. This visit will include a comprehensive assessment to evaluate the overall impact of the treatment.

You will be informed about the next steps and any additional follow-up that may be necessary after the study concludes.

Who Can Join the Study?

Must have the ability to understand and sign a written informed consent form before starting any study assessments.
Must be an adult male or female, aged 18 years or older, or as per the legal adult age in your country.
Must have a diagnosis of IgA Nephropathy (IgAN), confirmed by a kidney biopsy done within the last 10 years.
Must have a total urine protein excretion of at least 1.0 grams per 24 hours or a urine protein to creatinine ratio (UPCR) of at least 1.0 mg/mg, based on a 24-hour urine sample during the screening period.
Must have an eGFR (a measure of kidney function) of at least 30 mL/min/1.73 m² at screening, calculated using the CKD-EPI equation.
Must be on a stable prescribed regimen of RASi (medications like ACE inhibitors or ARBs) for at least 12 weeks at the maximum dose you can tolerate. If you cannot tolerate RASi, your IgAN management should follow standard care practices, and this must be documented by the study doctor.
Must have a systolic blood pressure (the top number) of 150 mmHg or lower and a diastolic blood pressure (the bottom number) of 90 mmHg or lower at screening.
If female, must not be pregnant or breastfeeding. You must have a negative pregnancy test at screening and on the first day of the study. If you are a woman of childbearing potential, you must agree to use a highly effective contraceptive method from at least 7 days before starting the study until 175 days after the last dose of the study drug.

Who Cannot Join the Study?

Patients who are not adults cannot participate. This means you must be at least 18 years old.
Patients with medical conditions other than IgA Nephropathy may not be eligible. IgA Nephropathy is a kidney disease.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients with certain other health conditions that could interfere with the study may not be eligible. This will be determined by the study doctors.
Patients who are unable to follow the study procedures or attend the required visits may not be eligible.

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
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal
Technische Universitaet Dresden	Dresden	Germany
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
University General Hospital Of Ioannina	Ioannina	Greece
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
General University Hospital Of Patras	Patras	Greece
Opca Bolnica Zadar	Zadar	Croatia
Odense University Hospital	Odense	Denmark
Tartu University Hospital	Tartu	Estonia
University Hospital Galway	Galway	Ireland
Ludwig Maximilian University Of Munich	Munich	Germany
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Aalborg University Hospital	Aalborg	Denmark
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ	Lodz	Poland
Rigshospitalet	Copenhagen	Denmark
KBC Split	Split	Croatia
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione	Pavia	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Algemeen Ziekenhuis Delta	Roeselare	Belgium
University General Hospital Of Heraklion	Heraklion	Greece
General Hospital of Nikaia-Piraeus, “Agios Panteleimon”	Piraeus	Greece
Region Sjaelland	Holbæk	Denmark
Ccks Ukvmbwvkif Hbpzfyej	Cork	Ireland
Cavlvhgc Subcveej Iqgbhdou	Barcelona	Spain
Lvnto Gakixqm Hpmndmab Ol Aisqlw	Athens	Greece
Htkguq Hjbrzgpx	Herlev	Denmark
Aznxaiwxbo Pzbvbkqb Hxilydup Dt Pgukq	Paris	France
Anpzll Uphwjekzqg Hdtuuzor	Aarhus	Denmark
Pxrahngzk Iykgrydq Mahdxqvi Mgjcfewzfrvb Sukkm Wsramhxjuqmk I Adovfkpjhzsui	Warsaw	Poland
Sp Vwjrrcotdvafhfq Udtlanuynw Higyinzg	Dublin	Ireland
Hatrwakz Vruw diemzosq	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	15.09.2021
Croatia	Not recruiting	15.09.2021
Czechia	Not recruiting	15.09.2021
Denmark	Not recruiting	15.09.2021
Estonia	Not recruiting	15.09.2021
France	Not recruiting	15.09.2021
Germany	Not recruiting	15.09.2021
Greece	Not recruiting	15.09.2021
Ireland	Not recruiting	15.09.2021
Italy	Not recruiting	15.09.2021
Poland	Not recruiting	15.09.2021
Portugal	Not recruiting	15.09.2021
Spain	Not recruiting	15.09.2021

Trial locations

Investigated drugs:

Atacicept is a medication being studied for its potential to help people with a kidney condition called IgA Nephropathy, or IgAN. This condition can cause the kidneys to leak protein into the urine, which is not normal. Atacicept works by targeting specific proteins in the body that are involved in the immune system. By doing this, it may help reduce the amount of protein in the urine and improve kidney function. The goal of the trial is to see if Atacicept is safe and effective for people with IgAN. Participants in the trial will receive Atacicept to see how it affects their condition compared to those who do not receive the medication.

IgA Nephropathy – IgA Nephropathy is a kidney disease that occurs when the antibody immunoglobulin A (IgA) builds up in the kidneys. This buildup causes inflammation that can affect the kidneys’ ability to filter waste from the blood. Over time, the inflammation can lead to kidney damage. The disease often progresses slowly over many years. Symptoms may include blood in the urine, protein in the urine, and swelling in the hands and feet. The progression of the disease can vary, with some individuals experiencing stable kidney function and others developing chronic kidney disease.

Trial ID:

2023-503772-24-00

Protocol code:

VT-001-0050

NCT ID:

NCT04716231

Trial Phase:

Therapeutic use (Phase IV)

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Study on the Effects of Atacicept in Adults with IgA Nephropathy

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