Mezagitamab for Kidney Disease

Not currently recruiting at 43 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called mezagitamab to identify potential side effects for individuals with certain kidney conditions. The primary focus is on those with primary IgA nephropathy or IgA vasculitis-related nephritis. Participants will receive a weekly injection under the skin for a period, followed by bi-weekly injections, to evaluate the treatment's effectiveness and any long-term effects. It suits individuals who have managed these conditions with stable treatment routines and received a kidney biopsy diagnosis within the past 10 years. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that mezagitamab is likely to be safe for humans?

A previous study found mezagitamab to be generally well-tolerated when combined with standard treatments for IgA nephropathy, a type of kidney disease. That study reported no serious infections or severe side effects, suggesting mezagitamab might be safe for humans, at least in the short term. However, this current study remains in its early stages, and researchers are still gathering safety data, particularly for long-term use. Participants in this trial will have their health closely monitored to ensure safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Mezagitamab is unique because it introduces a new approach to treating kidney disease through its innovative mechanism of action. Unlike traditional treatments that often focus on controlling symptoms or slowing progression, Mezagitamab is designed to target specific pathways involved in the disease process, potentially leading to more effective management. Additionally, its administration via subcutaneous injection offers a user-friendly alternative that could improve patient compliance compared to more invasive or complex treatments. Researchers are excited about Mezagitamab because it represents a promising new direction that could enhance outcomes for patients with kidney disease.

What evidence suggests that mezagitamab might be an effective treatment for kidney disease?

Research has shown that mezagitamab may help treat kidney disease. In earlier studies, patients experienced quick and lasting drops in UPCR, a key measure of kidney health. Mezagitamab was generally well tolerated, with most people not experiencing serious side effects. Additionally, there were decreases in certain antibodies and proteins, which can benefit kidney function. While these early results are promising, more research is needed to fully understand its effectiveness. Participants in this trial will receive mezagitamab as a subcutaneous injection once weekly for 8 weeks, then once every 2 weeks for 16 weeks. ^{1 2 3 4 6}

Who Is on the Research Team?

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06963827

NCT06963827 | A Study of Mezagitamab in Adults With ... The pre-specified assessment criteria will include: sustained decline in eGFR of ≥30% from baseline over at least 4 weeks; sustained eGFR <15 mL/min/1.73 m^2 ...

2. journals.lww.com journals.lww.com/10.1681/ASN.20243d4074tq

Interim Results from an Open-Label Phase 1b Study Conclusion: Mezagitamab was generally well tolerated as an add-on to standard of care therapy. Rapid and sustained reductions in UPCR, serum IgA, and Gd ...

3. pharmaceuticalmanufacturer.media pharmaceuticalmanufacturer.media/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/takeda-presents-positive-proof-of-concept-results-igan/

Takeda presents positive proof-of-concept results for IgAN ... Despite current treatments, around one in five patients experience renal failure within a decade.

4. academic.oup.com academic.oup.com/ndt/article/40/Supplement_3/gfaf116.0254/8294850

#47 Safety, tolerability, and efficacy of mezagitamab (TAK-079 ... Characteristics at study entry included mean disease duration of 4.6 years, UPCR of 1.5 mg/mg, and eGFR of 74.0 mL/min/1.73 m2. Sixteen (94.1%) ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05174221

NCT05174221 | A Study of Mezagitamab in Adults With ... This study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of mezagitamab in combination with stable background therapy.

6. researchgate.net researchgate.net/publication/396780760_47_Safety_tolerability_and_efficacy_of_mezagitamab_TAK-079_as_add-on_to_standard_of_care_therapy_in_individuals_with_primary_IgA_nephropathy_results_from_a_Phase_1b_study

47 Safety, tolerability, and efficacy of mezagitamab (TAK- ... This abstract focuses on data from the 48-week visit. Results Seventeen participants enrolled (mean age 40.8 years, 53% female, and 71% Asian).