A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy (NCT06963827)
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate Efficacy and Safety of Mezagitamab (TAK-079) in Study Participants With Primary IgA Nephropathy in Combination With Stable Background Therapy
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: UAB Nephrology Research Clinic at Paula Building — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (176 Sites)
Showing the first 25 of 176 sites.
- UAB Nephrology Research Clinic at Paula Building — Birmingham, Alabama
- DCR Montgomery — Montgomery, Alabama
- Panoramic Health - Southwest Kidney Institute, PLC — Surprise, Arizona
- Panoramic Health - West Coast Kidney Institute (Fremont) — Fremont, California
- Academic Medical Research Institute — Los Angeles, California
- University of California Irvine — Orange, California
- Panoramic Health - Florida Kidney Physicians, LLC (Jacksonville) — Jacksonville, Florida
- South Florida Research Institute — Lauderdale Lakes, Florida
- Panoramic Health - Florida Kidney Physicians, LLC (Melbourne) — Melbourne, Florida
- Bioresearch Partners — Miami, Florida
- CTR Oakwater, LLC — Orlando, Florida
- Bioresearch Partners — Pembroke Pines, Florida
- Panoramic Health - Florida Kidney Physicians, LLC (Tampa) — Riverview, Florida
- DCR Columbus — Columbus, Georgia
- Panoramic Health - Southeast Kidney Associates — East Point, Georgia
- CARE Institute - Boise Kidney — Boise, Idaho
- Panoramic Health - RNA of Rockford, LLC dba Rockford Nephrology Associates — Rockford, Illinois
- Northwest Louisiana Nephrology — Shreveport, Louisiana
- Ingham Nephrology & Hypertension, P.C. — Lansing, Michigan
- Elixia MKC — Pontiac, Michigan
- Panoramic Health - Lake Michigan Nephrology, PLC — Saint Joseph, Michigan
- DCR Edina — Edina, Minnesota
- Elixia MNA — City of Saint Peters, Missouri
- Clinical Research Consultants a JCCT Company — Kansas City, Missouri
- Renal Medicine Associates - Frenova F1 — Albuquerque, New Mexico
📞 Contact the Study Coordinator
Phone: (877) 825-3327
Email: medinfoUS@takeda.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.