Study of Mezagitamab in Adults with Primary IgA Nephropathy (Berger’s Disease) to Reduce Protein in Urine

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What is this study about?

This study focuses on Primary 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 mezagitamab (also known as TAK-079) given by subcutaneous injection under the skin, along with regular kidney disease treatments.

The purpose of this research is to determine if mezagitamab can reduce the amount of protein in the urine of people with Primary IgA Nephropathy. During the study, participants will receive either mezagitamab or placebo injections for up to 104 weeks (2 years). The medication or placebo will be given alongside their usual kidney disease treatments.

The study will monitor changes in kidney function and the amount of protein in participants’ urine throughout the treatment period. Researchers will also check for signs of improvement in other symptoms related to kidney disease, including the presence of blood in the urine. The study will track how well participants’ bodies respond to the treatment and measure the amount of medication in their blood.

1 Initial evaluation

Your participation begins with confirming that you have IgA Nephropathy (also known as Berger’s disease), documented by a kidney biopsy performed within the last 10 years

Your kidney function will be checked through tests to confirm that your estimated glomerular filtration rate (eGFR) is above 30 mL/min/1.73m2

Your urine protein levels must show either protein-to-creatinine ratio (UPCR) of 0.8 g/g or higher, or daily protein excretion of 1 g or more

Your blood pressure readings must be 150/100 mmHg or lower

2 Treatment phase – first 36 weeks

You will receive either mezagitamab or a placebo through subcutaneous injection (under the skin)

The main goal is to measure changes in your protein levels in urine after 36 weeks of treatment

Regular urine samples will be collected over 24 hours to measure protein levels

Your kidney function will be monitored through blood tests

3 Continued monitoring – up to 52 weeks

Your kidney function will continue to be monitored through regular blood tests

Changes in your kidney function will be tracked to detect any significant decline

The presence of blood in your urine will be monitored

4 Extended follow-up – up to 104 weeks

Long-term monitoring of your kidney function will continue

Regular testing will track protein levels in your urine

Blood samples will be taken to measure medication levels and check for antibodies

Your urine will be checked for the presence of blood

Who Can Join the Study?

  • Must have elevated protein levels in urine, shown by either:
    • A urine protein-to-creatinine ratio of 0.8 grams or higher, or
    • Daily protein excretion of 1 gram or more in a 24-hour urine collection
  • Must have adequate kidney function with an eGFR (estimated glomerular filtration rate – a measure of kidney function) greater than 30 mL/min/1.73m²
  • Must have been diagnosed with primary IgA Nephropathy (Berger’s disease) confirmed by a kidney biopsy performed within the last 10 years
  • Must have controlled blood pressure with:
    • Systolic (upper number) pressure of 150 mmHg or less
    • Diastolic (lower number) pressure of 100 mmHg or less
  • Must be an adult (18 years or older)
  • Can be either male or female

Who Cannot Join the Study?

  • Age under 18 years or over 75 years
  • Pregnant or breastfeeding women
  • History of kidney transplant
  • Active infection requiring treatment
  • History of cancer in the past 5 years (except successfully treated skin cancer)
  • Current treatment with other investigational drugs
  • Severe liver disease (problems with liver function)
  • Uncontrolled diabetes (high blood sugar levels)
  • Severe heart disease or heart failure
  • History of severe allergic reactions to medications
  • Active autoimmune disease (when body’s immune system attacks healthy cells) other than IgA Nephropathy
  • Major surgery within 3 months before starting the study
  • Alcohol or drug 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

Other Sites

Site Name City Country Status
Region Oestergoetland Linkoping Sweden
Azienda Unita Sanitaria Locale Di Piacenza Piacenza Italy
Universitaetsklinikum Aachen AöR Aachen Germany
Hospital Del Mar Barcelona Spain
St. Olavs Hospital HF Trondheim Norway
Helse Stavanger HF Stavanger Norway
UNIVERZITETNI KLINICNI CENTER MARIBOR Maribor Slovenia
Scm Sp. z o.o. Cracow Poland
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Hospital Universitario De Cruces Barakaldo Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
IRCCS Ospedale Policlinico San Martino Genoa Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Nemocnice AGEL Novy Jicin a.s. Novy Jicin Czechia
Centre Hospitalier Universitaire De Nantes Nantes France
University Medical Center Ljubljana Ljubljana Slovenia
University Hospital Olomouc Olomouc Czechia
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Virgen del Rocío University Hospital Sevilla Spain
Sykehuset Oestfold HF Kalnes Graalum Norway
Universita Degli Studi Di Brescia Brescia Italy
Semmelweis University Budapest Hungary
Stichting Radboud University Medical Center Nijmegen The Netherlands
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione Pavia Italy
Hopital Beaujon Clichy France
Sykehuset I Vestfold HF Tonsberg Norway
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari Bari Italy
Nshd Subkbwq Sbq z otfa Swiecie Poland
Ltnhv Uwkkgldycjbp Mpedmjj Cjemgpz (fdubf Leiden The Netherlands
Hwoqg Bjwjag Hx Bergen Norway
Awsjunv Oaepcihstmo Uscwckiskucpn Cfvgahcgtnwl Dkqbs Shhqjz E Djkue Stjfses Db Thebgm Turin Italy
Cwcewc Hhbutoeltac En Ufzecrnbkrdin Dg Lwmyfnj Limoges France
Akjtrppg Uziyiverio Hvnsuwjg Lorenskog Norway
Afaqvipmw Utj Amsterdam The Netherlands
Amfkkye Uifay Svpwckqik Lrubyw Dw Blfdhmt Bologna Italy
Hdvuiyso Ukjswlqowjipu Hajwhwje Tvkuf y Ppjkaa Inuivxmx Cmlmzj ddttcyrsoxqrcghsp (duzn Badalona Spain
Jvtsxquc Kgpnfz Uxeldaamhh Linz Austria
Htgmudae Vioc dtpmdmuz Barcelona Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
10.09.2025
Czechia Czechia
Recruiting
10.09.2025
France France
Recruiting
10.09.2025
Germany Germany
Recruiting
10.09.2025
Hungary Hungary
Recruiting
10.09.2025
Italy Italy
Recruiting
10.09.2025
Norway Norway
Recruiting
10.09.2025
Poland Poland
Recruiting
10.09.2025
Slovenia Slovenia
Recruiting
10.09.2025
Spain Spain
Recruiting
10.09.2025
Sweden Sweden
Recruiting
10.09.2025
The Netherlands The Netherlands
Recruiting
10.09.2025

Trial locations

Mezagitamab (TAK-079) is an investigational medication being studied for treating IgA nephropathy, a kidney disease where abnormal antibodies build up in the kidneys. The medication is designed to work with other background therapies to help reduce the amount of protein in the urine (proteinuria), which is a key indicator of kidney damage in people with IgA nephropathy. This medication targets specific components of the immune system that are believed to be involved in the disease process.

Primary Immunoglobulin A Nephropathy (IgAN) – A kidney disease also known as Berger’s disease, where abnormal immunoglobulin A (IgA) proteins build up in the kidneys. The disease causes inflammation in the tiny filtering units of the kidneys called glomeruli. This condition leads to the release of protein and blood into the urine. Over time, IgAN affects the kidneys’ ability to filter waste products from the blood. The disease typically progresses slowly, and symptoms may include changes in urination patterns and visible blood in the urine.

Trial ID:
2025-520825-19-00
Protocol code:
TAK-079-3001
NCT ID:
NCT06963827
Trial Phase:
Therapeutic confirmatory (Phase III)

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