Mezagitamab for Kidney Disease

Recruiting at 38 trial locations

Overseen By Takeda Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Takeda

Must be taking: Ace inhibitors, Arbs

Must not be taking: Immunosuppressants, Corticosteroids, Biologics, Vaccines

Disqualifiers: Significant renal disease, Nephrotic syndrome, Active vasculitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 24 weeks

16 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing mezagitamab, a new drug, to see if it can help people with a specific kidney disease called Primary Immunoglobulin (IgA) Nephropathy. The drug is given as an injection, and researchers will monitor its safety and effectiveness.

Will I have to stop taking my current medications?

The trial requires that you stay on a stable dose of ACE-I or ARB medications for IgAN for at least 12 weeks before screening and throughout the study. However, you cannot use certain immunosuppressive agents, systemic corticosteroids, or B-cell-directed biologic therapies within specific timeframes before and during the study.

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

Adults with primary IgA Nephropathy (kidney disease) who have been on stable ACE-I or ARB therapy for at least 12 weeks can join. They must have a kidney biopsy confirming their diagnosis within the last 10 years, an eGFR of >=45 mL/min/1.73m^2, and significant protein in their urine. Excluded are those with other major kidney diseases, recent steroid use, certain infections like hepatitis B/C or HIV, inadequate organ function, participation in another study recently, vaccine administration close to screening time, and various other medical conditions.

Inclusion Criteria

My kidney biopsy within the last 10 years confirms I have IgA nephropathy.

My kidney function, measured by eGFR, is adequate.

I have been on a stable dose of ACE-I or ARB for my IgAN for at least 12 weeks.

Exclusion Criteria

My IgA nephropathy is not caused by another major health condition.

I tested positive for TB with a TIGRA test.

I haven't used specific immune-targeting drugs in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive a subcutaneous injection of mezagitamab once a week for 8 weeks, then once every 2 weeks for 16 weeks

24 weeks

Weekly visits for 8 weeks, then bi-weekly visits for 16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Regular follow-up visits

Long-term Extension

Participants who benefit from the treatment may continue in the study for up to 96 weeks and possibly be retreated for another 24 weeks

Up to 120 weeks

Regular monitoring visits

Treatment Details

Interventions

• Mezagitamab

Trial Overview The trial is testing Mezagitamab's safety and long-term side effects in treating IgA Nephropathy. Participants will receive subcutaneous injections weekly for 8 weeks then bi-weekly for 16 weeks alongside their current medications. After treatment ends there's a follow-up period of 24 weeks; some may continue up to an additional 96 weeks if beneficial.

Participant Groups

Group I: Mezagitamab Experimental Treatment 1 Intervention

Mezagitamab, subcutaneous injection, once weekly for 8 weeks then once every 2 weeks for 16 weeks in the Main Study. Same dosing regimen will be repeated in LTE Retreatment Period.

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier