Mezagitamab for IgA Nephropathy

A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy

Recruiting Phase 3 Interventional Study
Kidney Disease
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
347 (estimated)
Sponsor
Takeda · Industry
Who this trial is looking for

This trial is looking for adults with a kidney condition called IgA nephropathy. Participants will receive either mezagitamab or a placebo for 22 weeks and then be monitored for about 1.5 years.

Are You a Good Fit for This Trial?
Must be taking RAAS inhibitor

You may be able to join if

  • I am at least 18 years old.
  • I have protein in my urine.
  • I have a specific kidney function level (eGFR greater than 30).
  • I am stable on certain kidney medications for at least 12 weeks.
  • I have a diagnosis of IgA nephropathy confirmed by a recent kidney biopsy.
  • I have given written consent to participate.

You may not be able to join if

  • I have another significant kidney disease besides IgA nephropathy.
  • I have been diagnosed with nephrotic syndrome.
  • I have received certain treatments in the last 6 months.
  • I have a live vaccine planned during the trial.
  • I have an active infection with hepatitis.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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 leve…
Trial Locations
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Eligibility Criteria
* Inclusion Criteria: To be eligible to participate in this trial, participants must meet all the following criteria: 1. Either UPCR greater than or equal to (≥) 0.8 gram per gram (g/g) or urine protein excretion (UPE) ≥1 grams per day (g/day), calculated from at least one 24-hour urine collection…
Contacts

Takeda Contact

+1-877-825-3327

medinfoUS@takeda.com

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