At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Mezagitamab (drug), Placebo (drug)
- How long the study runs
- Study runs about 54 months (dates as stated)
- About the drug or intervention
- Mezagitamab — drug: Mezagitamab injections administered SC. · Placebo — drug: Mezagitamab-matching placebo injections administered SC.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 347
- Started
- 2025-07-15
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for kidney disease
- • Phase3 - 347 participants
- • Immunoglobulin A nephropathy (IgAN) is a kidney condition
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with kidney disease
Where?
- • London - Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
- • Birmingham - Birmingham Heartlands Hospital
- • Canterbury - Kent & Canterbury Hospital, Canterbury
- • Hull - Hull University Teaching Hospitals NHS Trust
- • +6 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Immunoglobulin A nephropathy (IgAN) is a kidney condition. It happens when the body's immune system creates groups of proteins (called immune complexes) that build-up in the kidneys causing swelling (inflammation). Over time, this inflammation may lead to kidney damage and cause the kidneys to no longer work properly. The main aim of this study is to check how well mezagitamab changes protein levels in the urine (proteinuria) compared to placebo in adults with primary IgAN. A placebo looks like medicine but doesn't have any active ingredients in it. Other aims are to check how safe mezagitamab is and how well participants with primary IgAN can tolerate it compared to placebo, and to find out if and how well mezagitamab continues to maintain kidney function over the long term compared to placebo. Participants will be placed in 1 of the 2 treatment groups; the main group and the open-label group. In the main group, participants will be placed by chance in either the mezagitamab or placebo treatment group at a 2:1 ratio. This means that out of 3 participants, 2 will receive mezagitamab and 1 will receive placebo. Participants can be in the study for 2 years (104 weeks). Participants will receive study treatment for about half a year (22 weeks) and then be observed for the remainder of the study (about 1.5 years). During observation, participants will continue to have check-ups about every month. In the open-label group, a small number of participants who either have lower levels of protein in their urine or have kidneys that do not filter the blood well, will receive mezagitamab treatment. This will include participants who have previously received mezagitamab in another study, TAK-079-1006. Every participant will receive mezagitamab in the same way as those in the main group receiving mezagitamab. During the study, participants will visit their study clinic several times.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ privacy authorization
What the study is looking for
- ✓To be eligible to participate in this trial, participants must meet all the following criteria:
- ✓No prior exposure to anti- cluster of differentiation 38 (CD38) therapy period (except for everyone knows which treatment they get cohort...
- ✓The participant is aged ≥ 18 years or the local legal age as applicable.
- ✓Resting blood pressure less than or equal to (≤)150 millimeters of mercury (mmHg) systolic and ≤100 mmHg diastolic.
- ✓Any one of the following (only applicable for participants in the everyone knows which treatment they get cohort):
Who cannot take part
- ✗A participant who meets any of the following criteria will be excluded from participation in this trial:
- ✗Kidney biopsy exhibiting significant concomitant kidney disease other than IgAN (for example, diabetic nephropathy,...
- ✗Secondary IgAN (such as with significant liver disease, inflammatory bowel disease, and seronegative...
- ✗Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months before the signing of the ICF).
- ✗Diagnosis of nephrotic syndrome defined as 24-hour proteinuria \>3.5 g/day and hypoalbuminemia (\<3.0 grams per...
See the full criteria
Where Is This Study? (10 UK sites)
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
London SE1 9RT, United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Kent & Canterbury Hospital, Canterbury
Canterbury CT1 3PA, United Kingdom
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom
Leicester General Hospital
Leicester, United Kingdom
St George's University Hospitals NHS Foundation Trust
London SW17 0QT, United Kingdom
King's College Hospital
London WC2R 2LS, United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham, United Kingdom
Lancashire Teaching Hospital NHS Foundation Trust
Preston PR29HT, United Kingdom
Northern General Hospital
Sheffield, United Kingdom
How to Get in Touch
Takeda Contact
Sponsor contactCONTACT
