What side effects are associated with this type of intervention?

Common treatments for kidney disease, including those similar to mezagitamab, often have side effects such as proteinuria, hypertension, and renal events. Other potential adverse effects include nausea, anemia, edema, neutropenia, and fatigue. Long-term use of these treatments may increase the incidence of renal complications. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for kidney diseases, particularly those involving immunosuppressive and targeted therapies. For example, Rituximab has been used for ANCA-associated renal vasculitis, showing similar efficacy to cyclophosphamide-based regimens. Additionally, corticosteroids like methylprednisolone are commonly used in combination with other immunosuppressants such as cyclophosphamide and azathioprine for various forms of glomerulonephritis, including IgA nephropathy. These treatments aim to reduce inflammation and immune response, similar to the approach being studied with Mezagitamab.

What other types of research exist?

Promising alternatives to Mezagitamab for kidney disease patients include Bortezomib, which has been studied for antibody-mediated kidney transplant rejection, and various tyrosine kinase inhibitors (TKIs) like Afatinib and Imatinib, which have shown potential in managing renal complications. Additionally, immunotherapy agents such as Pembrolizumab and Nivolumab, used in renal cell carcinoma, may offer novel therapeutic options.

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Monoclonal Antibodies

Mezagitamab for Kidney Disease

Phase 1

Waitlist Available

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Estimated glomerular filtration rate (eGFR) >= 45 milliliter per minute per 1.73 square meter (mL/min/1.73m^2) at screening

Receiving stable background therapy for IgAN (angiotensin-converting enzyme inhibitor [ACE-I] or angiotensin receptor blocker [ARB]) for 12 weeks prior to screening. The ACE-I and ARB dose should represent the maximum tolerated or maximum labeled dose, as determined by the investigator, for a minimum of 3 months and remain stable during the entire duration of the study

Must not have

Use of systemic corticosteroids within 4 months from screening visit or expected use for the duration of the study

A positive T-cell interferon-gamma release assay (TIGRA) (result through QuantiFERON-TB Gold test or T-Spot/Elispot) at the screening visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 96

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, potential side effects from mezagitamab could include reactions at the injection site such as pain or swelling, allergic reactions due to the body’s immune response to the medication which might manifest as rash or fever among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function, measured by eGFR, is adequate.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't used systemic corticosteroids in the last 4 months and don't plan to use them during the study.

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I tested positive for TB with a TIGRA test.

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I have been diagnosed with nephrotic syndrome.

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My organs and bone marrow are not functioning well.

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I do not have severe or uncontrolled heart failure.

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I haven't taken any strong immune system suppressing drugs in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 96

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 96

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 96 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

LTE Observation Period: Percentage of Participants With one or More TEAEs, Grade 3 or Higher TEAEs and SAEs

LTE Retreatment Period: Percentage of Participants With one or More TEAEs, SAEs, Grade 3 or Higher TEAEs and AEs leading to Mezagitamab Discontinuation

Main Study: Percentage of Participants With one or More Treatment-emergent Adverse Events (TEAEs), Grade 3 or Higher TEAEs, Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Mezagitamab Discontinuation

Secondary study objectives

LTE Observation Period: Percent Change From Baseline in Proteinuria Based on UPCR

LTE Retreatment Period: Percentage of Participants Based on ADA Levels in Serum

Main Study: Percent Change From Baseline in Proteinuria Based on Urine Protein to Creatinine Ratio (UPCR)

+1 more

Side effects data

From 2022 Phase 1 & 2 trial • 50 Patients • NCT03439280

50%

Neutropenia

50%

Neutrophil count decreased

33%

Constipation

33%

Upper respiratory tract infection

33%

Cough

33%

Muscle spasms

33%

Neuropathy peripheral

33%

Urinary tract infection

33%

Fatigue

17%

Venous thrombosis limb

17%

Dizziness

17%

Flushing

17%

Headache

17%

Gastrooesophageal reflux disease

17%

Hypokalaemia

17%

Hypoaesthesia

17%

Hypersensitivity

17%

Acute myocardial infarction

17%

Pruritus

17%

Coronavirus test positive

17%

Iron deficiency anaemia

17%

Nausea

17%

Vomiting

17%

Diarrhoea

17%

COVID-19

17%

Abdominal pain

17%

Alopecia

17%

COVID-19 pneumonia

17%

Clavicle fracture

17%

Dyskinesia

17%

Dyspnoea

17%

Hyperglycaemia

17%

Influenza

17%

Influenza like illness

17%

Injection site haemorrhage

17%

Insomnia

17%

Joint stiffness

17%

Myalgia

17%

Oropharyngeal pain

17%

Pneumonia

17%

Rhinitis

17%

Sleep apnoea syndrome

17%

Stomatitis

17%

Oesophageal candidiasis

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex

Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg

Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg

Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg

Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg

Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: MezagitamabExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mezagitamab

2018

Completed Phase 2

~50

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for kidney disease, such as mezagitamab, glucocorticoids, and immunosuppressive agents, work through different mechanisms to manage the condition. Mezagitamab, an investigational drug, is administered subcutaneously and aims to modulate the immune system to reduce inflammation and proteinuria. Glucocorticoids, like prednisolone, reduce inflammation by suppressing the immune response, which can help improve kidney function and reduce proteinuria. Immunosuppressive agents, such as cyclophosphamide and azathioprine, inhibit the immune system to prevent further kidney damage. These treatments are crucial for kidney disease patients as they help manage symptoms, slow disease progression, and improve overall kidney function.

Role of immunosuppressive therapy and predictors of therapeutic effectiveness and renal outcome in IgA nephropathy with proteinuria.Dual RAS therapy not on target, but fully alive.