Study of Atacicept Treatment for Patients with Multiple Autoimmune Glomerular Diseases

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What is this study about?

This clinical trial focuses on testing a medication called atacicept (VT-001) in people with Multiple Autoimmune Glomerular Diseases. These are conditions where the immune system attacks the kidneys’ filtering units, leading to protein leakage into urine. The study specifically looks at different types of kidney diseases, including IgA Nephropathy, Membranous Nephropathy, Minimal Change Disease, and Focal Segmental Glomerulosclerosis.

The purpose of this study is to evaluate how safe atacicept is and how well it works in reducing the amount of protein in the urine. The medication is given as a subcutaneous injection using a pre-filled syringe. Participants will receive treatment while continuing their regular standard of care medications as prescribed by their doctors.

The study will last for 52 weeks, during which participants will receive regular doses of atacicept. Throughout the study, doctors will monitor various aspects of kidney function, particularly the amount of protein in the urine and how well the kidneys are filtering blood. They will also track the levels of specific disease markers in the blood that are associated with each type of kidney disease.

1 Initial assessment

A screening visit will confirm if you meet the study requirements, including checking your blood pressure, weight (must be 40 kg or more), and reviewing your medical history

Your kidney function will be assessed through proteinuria (protein in urine) measurements and eGFR (kidney function test)

2 Treatment initiation

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

The medication comes in a pre-filled syringe for easier administration

You will continue your current standard treatment as prescribed by your doctor

3 Week 12 assessment

Your protein levels in urine will be measured

Your kidney function will be monitored

Blood samples will be taken to measure atacicept levels in your body

4 Week 24 assessment

Your response to treatment will be evaluated

Protein levels in urine will be measured

Blood tests will continue to monitor atacicept levels

5 Week 36 main evaluation

This is a key assessment point to measure changes in protein levels in your urine since starting treatment

Your kidney function will be thoroughly evaluated

6 Week 52 final assessment

Final evaluation of your kidney function

Measurement of protein levels in urine

Final blood tests to check atacicept levels

Overall assessment of your response to treatment

Who Can Join the Study?

  • Must be currently receiving stable prescribed standard of care treatment according to local medical guidelines
  • Blood pressure requirements:
    • For adults: systolic blood pressure must be 160 mmHg or lower and diastolic blood pressure must be 90 mmHg or lower
    • For participants aged 10-17 years: blood pressure must be below the 95th percentile for their age, gender, and height
  • Must weigh at least 40 kilograms
  • Must agree to follow the study’s contraceptive guidelines
  • Disease-specific requirements:
    • For IgA Nephropathy (IgAN) patients:
      • Must have biopsy-confirmed IgAN or IgA vasculitis with nephritis
      • Protein levels in urine must be between 0.5 and 5 grams per gram of creatinine
      • Must have adequate kidney function (eGFR ≥ 20)
    • For Membranous Nephropathy (pMN) patients:
      • Must be 18 years or older
      • Must have biopsy-confirmed pMN with specific antibodies (anti-PLA2R ≥ 25 RU/mL)
      • Protein in urine must be at least 1.5 grams per gram of creatinine
    • For Minimal Change Disease (MCD) or Focal Segmental Glomerulosclerosis (FSGS) patients:
      • Must have biopsy-confirmed primary MCD or FSGS
      • Protein in urine must be at least 1.0 gram per gram of creatinine
      • Must have adequate kidney function (eGFR ≥ 30)
      • Must have evidence of specific antibodies (anti-nephrin)

Who Cannot Join the Study?

  • Age below 18 years or above 75 years
  • Known hypersensitivity (severe allergic reactions) to atacicept or any of its components
  • Currently pregnant or breastfeeding women
  • Severe kidney dysfunction (estimated glomerular filtration rate below 30 mL/min/1.73m²)
  • Active or chronic infections, including hepatitis B, hepatitis C, or HIV
  • History of cancer within the past 5 years (except successfully treated non-melanoma skin cancer)
  • Major surgery within 8 weeks before starting the study
  • Uncontrolled high blood pressure (systolic >160 mmHg or diastolic >100 mmHg)
  • Severe heart disease or heart failure
  • Active liver disease or significant liver function abnormalities
  • Use of other investigational drugs within 30 days or 5 half-lives before study start
  • History of drug or alcohol abuse within the past year
  • Mental conditions that could interfere with study participation
  • Any medical condition that the study doctor believes would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Sanitaria Universitaria Giuliano Isontina Trieste Italy
Centre Hospitalier Universitaire De Nimes Nimes France
Universitair Ziekenhuis Gent Gent Belgium
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Universitaetsklinikum Aachen AöR Aachen Germany
Algemeen Ziekenhuis Delta Roeselare Belgium
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Istituto Di Ricerche Farmacologiche Mario Negri Ranica Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
Pratia S.A. Skorzewo Poland
Centre Hospitalier Universitaire De Nice Nice France
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace Mulhouse France
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
Ziekenhuis Oost Limburg Genk Belgium
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione Pavia Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hopital Beaujon Clichy France
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari Bari Italy
Conxwikkt Uezggacbsfmmpu Siafqytms Woluwe-Saint-Lambert Belgium
Uofhvzfxbwnkgdvsoyafy Evdxa Apy Essen Germany
Azuakbn Ouyntoolxmi Uhvxqpcwvbrpm Cyobxlbyskbw Dwjye Sejaxa E Dgblr Sjyrojh Du Temdmu Turin Italy
Gijaqq Ufzxqakoxz Fapmyhden Frankfurt Germany
Ahxdfav Uivub Sfzmwvsdu Lcjjbm Dv Byxhtgu Bologna Italy
Hjdimmoc Vuqa dyemrwcj Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.01.2026
France France
Recruiting
01.01.2026
Germany Germany
Recruiting
01.01.2026
Italy Italy
Recruiting
01.01.2026
Poland Poland
Recruiting
01.01.2026
Spain Spain
Recruiting
01.01.2026

Trial locations

Investigated drugs:

Atacicept is a medication being studied for treating various autoimmune diseases that affect the kidneys (glomerular diseases). It works by targeting specific proteins in the immune system that are involved in the inflammatory process. This medication aims to reduce protein in the urine (proteinuria) and help control the immune system’s attack on kidney tissues.

Multiple Autoimmune Glomerular Disease – A group of kidney disorders where the immune system attacks and damages the glomeruli, the tiny filtering units in the kidneys. The condition typically involves inflammation of the glomeruli, leading to protein leakage into urine (proteinuria). The disease can affect both kidneys simultaneously and often progresses gradually over time. Different forms of this condition can involve various immune system components attacking different parts of the kidney’s filtering system. The damage to glomeruli can cause problems with the kidney’s ability to filter waste products from the blood.

IgA Nephropathy – A kidney disease that occurs when immunoglobulin A (IgA) builds up in the kidneys, causing inflammation that damages kidney tissues. The disease progresses slowly and affects the kidney’s filtering units called glomeruli. It causes protein and blood to leak into the urine. The condition often develops during early adulthood.

Membranous Nephropathy – A kidney disease characterized by thickening of the glomerular basement membrane due to immune deposits. The condition causes damage to the filtering membranes in the kidneys, leading to significant protein loss in the urine. It develops gradually and primarily affects adults. The disease can result in swelling in various body parts due to protein loss.

Trial ID:
2024-518465-10-00
Protocol code:
VT-001-0060
Trial Phase:
Therapeutic exploratory (Phase II)

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