Actively Recruiting
Phase 3 Trial of Mezagitamab Injections for Adults with Primary IgA Nephropathy Kidney Disease
Led by Takeda · Updated on 2026-07-31
347
Participants Needed
175
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate mezagitamab for adults with primary Immunoglobulin A nephropathy IgAN, a kidney disease caused by immune protein buildup leading to inflammation and potential kidney damage. The study will compare how mezagitamab affects protein levels in urine proteinuria against a placebo, focusing on safety, tolerability, and maintenance of kidney function over time. Participants will be randomly assigned to either receive mezagitamab or a placebo injection subcutaneously over approximately 22 weeks in the main group, with a 21 ratio favoring mezagitamab. An open-label group includes participants with specific proteinuria or kidney filtration levels, including those from a prior related study, all receiving mezagitamab in the same manner. After treatment, participants will be observed for about 1.5 years with regular check-ups. During the study, participants will attend multiple clinic visits for treatment and monitoring. Researchers will measure changes in proteinuria at Week 36 as the primary outcome, as well as kidney filtration rates over one and two years. Safety and long-term kidney function will be closely monitored throughout the 2-year participation period.
CONDITIONS
Brief Title
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of primary IgA nephropathy confirmed by kidney biopsy within 10 years
- Urine protein-to-creatinine ratio (UPCR) ≥ 0.8 g/g or urine protein excretion (UPE) ≥ 1 g/day (main trial participants)
- Estimated glomerular filtration rate (eGFR) > 30 mL/min/1.73m² (main trial participants)
- No prior exposure to anti-CD38 therapy (except certain open-label cohort participants)
- Stable use of renin-angiotensin-aldosterone system inhibitors (ACE inhibitors, ARBs, ERA, or MRA) for at least 12 weeks before enrollment
- Resting blood pressure ≤ 150/100 mmHg
- Female participants of childbearing potential must not be pregnant and must use contraception
- Participants or their legal representatives must provide informed consent
You will not qualify if you...
- Kidney biopsy showing significant other kidney diseases besides IgAN
- Secondary IgAN or IgA vasculitis
- Rapidly progressive glomerulonephritis with >50% eGFR loss within 3 months
- Nephrotic syndrome with proteinuria >3.5 g/day and low albumin levels
- Prior or planned organ transplantation
- Recent use of immunosuppressive or biologic therapies within 6 months
- Recent anti-CD20 treatment within 6 to 12 months with low CD19+ count
- Recent use of high-dose corticosteroids or oral budesonide within 4 months
- Live vaccines within 4 weeks before enrollment or planned during trial
- Participation in other investigational drug trials within 4 weeks or 5 half-lives
- Active infections including hepatitis B, hepatitis C, HIV, tuberculosis, or serious infections
- Medical conditions that may interfere with trial participation or pose additional risk
- History of major surgery within 3 months or tonsillectomy within 6 months before screening
- Cancer within 5 years except certain treated types
- History of severe allergic reaction to study drugs
- Severe COPD or asthma with low lung function
- Breastfeeding participants unwilling to stop during treatment
- Participants unwilling to use effective contraception as required
- Inability or unwillingness to comply with trial procedures and requirements
Research Team
T
Takeda Contact
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