Study of Monthly Atacicept Injections in Patients with IgA Nephropathy (Berger Disease)

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What is this study about?

This study focuses on IgA Nephropathy (also known as Berger’s Disease), which is a kidney condition where proteins called immunoglobulins build up in the kidneys and cause damage. The study will test a medication called atacicept (VT-001), which is given as an injection under the skin once every four weeks.

The purpose of this research is to evaluate how atacicept affects certain proteins in patients with IgA Nephropathy. The medication comes in the form of a pre-filled syringe containing a solution for injection. During the study, participants will receive monthly injections of the study medication for 24 weeks.

Throughout the study period, various measurements will be taken to monitor protein levels in the blood and urine, as well as to check how well the medication is working and ensure patient safety. The total duration of treatment may last up to 48 weeks, during which patients will continue to receive their usual standard of care treatments for their condition.

1 Initial assessment

You will receive a detailed evaluation to confirm your diagnosis of IgA Nephropathy (IgAN), also known as Berger Disease

Your blood pressure will be checked to ensure it meets the required levels (systolic ≤160 mmHg and diastolic ≤90 mmHg)

Your kidney function will be assessed through tests measuring protein in urine and estimated glomerular filtration rate (eGFR)

2 Treatment initiation

You will receive atacicept as a solution for injection under the skin (subcutaneous injection)

The medication will be provided in pre-filled syringes

The treatment will be administered every 4 weeks (monthly)

3 Monitoring through week 24

Regular blood tests will be performed to measure levels of specific proteins (Gd-IgA1, IgG, IgM, and IgA)

Your urine will be tested to measure protein levels using the urine protein-to-creatinine ratio (UPCR)

Blood samples will be taken to measure the amount of atacicept in your system

Tests will be conducted to check for antibodies against the study medication

4 Safety monitoring

Regular laboratory tests will be performed to monitor your health

Your vital signs will be checked during study visits

Any side effects will be recorded and monitored throughout the study

The study will continue monitoring your health until the end of the study period

Who Can Join the Study?

Must be at least 18 years old and able to provide written informed consent before any study procedures
Must have confirmed IgA Nephropathy through kidney biopsy with either:
- Total urine protein of at least 0.75 grams in a 24-hour period, or
- Urine protein-to-creatinine ratio of at least 0.75 mg/mg from a 24-hour urine sample
Must have adequate kidney function with eGFR (estimated glomerular filtration rate – a measure of kidney function) of at least 30 ml/min/1.73m²
Must be on a stable prescribed standard of care treatment according to local medical practice
Must have controlled blood pressure with:
- Systolic blood pressure (upper number) not higher than 160 mmHg
- Diastolic blood pressure (lower number) not higher than 90 mmHg
Both men and women can participate in the study

Who Cannot Join the Study?

History of kidney transplant or currently on dialysis
Known allergies to study medications
Presence of other types of kidney diseases besides IgA Nephropathy
Active infections or serious illnesses
Liver disease or abnormal liver function tests
Uncontrolled high blood pressure (blood pressure consistently above 140/90)
Pregnant women or planning pregnancy during the study period
Breastfeeding mothers
Use of other investigational drugs within 30 days before study start
History of cancer within the past 5 years
Active autoimmune diseases (conditions where the immune system attacks healthy cells)
Blood disorders or significant abnormalities in blood tests
History of substance abuse within the past year
Mental conditions that could interfere with study participation
Unable to provide informed consent

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
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Del Mar	Barcelona	Spain
Hospital Universitario Torrecardenas	Almeria	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ	Lodz	Poland
Puykdsumv Iljpbtab Mumhkxrv Mnujbkyoiurk Sbojx Wftdsuwqxars I Auvpfhormyspm	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	15.09.2025
Spain	Not recruiting	15.09.2025

Trial locations

Investigated drugs:

Atacicept

Atacicept is a medication that targets specific proteins in the immune system. It works by reducing the production of certain antibodies that can cause damage to the kidneys in patients with IgA nephropathy (IgAN). This medication is designed to be given once every four weeks and aims to help patients who have a condition where abnormal antibodies build up in their kidneys.

IgA Nephropathy (Berger Disease) – A kidney disease that occurs when an antibody called immunoglobulin A (IgA) builds up in the kidneys. This accumulation of IgA creates inflammation that gradually affects the kidney’s filtering ability. The disease develops slowly over many years, and the body’s immune system produces an abnormal form of IgA that collects in the kidneys. As the IgA deposits build up, they cause inflammation and damage to the kidney tissues. The condition primarily affects the glomeruli, which are the tiny filtering units in the kidneys. The disease can occur at any age, but it most often develops during adolescence or early adulthood.

Trial ID:

2025-521519-37-00

Protocol code:

VT-001-0020

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Monthly Atacicept Injections in Patients with IgA Nephropathy (Berger Disease)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?