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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 56 pre-dose and at multiple time points (up to week 96)
Awards & highlights

Study Summary

This trial will study the side effects and long-term effects of mezagitamab, given as injections under the skin. Before starting, participants will provide a urine sample. If enrolled, they will receive injections once a week for 8 weeks, then once every 2 weeks for 16 weeks. There will be a 24-week follow-up period. If participants benefit from the treatment, they may continue in the second part of the study for up to 96 weeks and possibly be retreated for another 24 weeks.

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.Check my eligibility
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.See study design
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
Select...
My kidney function, measured by eGFR, is adequate.
Select...
I have been on a stable dose of ACE-I or ARB for my IgAN for at least 12 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 56 pre-dose and at multiple time points (up to week 96)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 56 pre-dose and at multiple time points (up to week 96) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
LTE Observation Period: Percent Change From Baseline in Proteinuria Based on UPCR
LTE Observation Period: Percentage of Participants Based on ADA Levels in Serum
LTE Observation Period: Serum IgA Levels
+5 more

Side effects data

From 2022 Phase 1 & 2 trial • 50 Patients • NCT03439280
33%
Headache
33%
Back pain
33%
Fatigue
25%
Nausea
25%
Cough
25%
Insomnia
25%
Anaemia
17%
Vitamin D deficiency
17%
Upper respiratory tract infection
17%
Arthralgia
17%
Bronchitis
17%
Decreased appetite
17%
Musculoskeletal chest pain
17%
Dyspnoea
8%
Abdominal distension
8%
Dizziness
8%
Viral upper respiratory tract infection
8%
Diarrhoea
8%
Neck pain
8%
Fungal skin infection
8%
Folliculitis
8%
Plasmacytoma
8%
Rotator cuff syndrome
8%
Vision blurred
8%
Platelet count decreased
8%
Gingival pain
8%
Joint swelling
8%
Nocturia
8%
Soft tissue infection
8%
Upper-airway cough syndrome
8%
Aspartate aminotransferase increased
8%
Epistaxis
8%
Neutropenia
8%
Rash follicular
8%
Blood creatinine increased
8%
Rash maculo-papular
8%
Abdominal pain upper
8%
Erectile dysfunction
8%
Hyperkalaemia
8%
Hyperuricaemia
8%
Hypoglycaemia
8%
Ligament sprain
8%
Myalgia
8%
Nasal congestion
8%
Non-cardiac chest pain
8%
Oedema
8%
Oropharyngeal pain
8%
Pain in extremity
8%
Pathological fracture
8%
Peripheral sensory neuropathy
8%
Pleuritic pain
8%
Pollakiuria
8%
Thermal burn
8%
Tongue ulceration
8%
Chills
8%
Vomiting
8%
Flank pain
8%
Peripheral swelling
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg
Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg
Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex
Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg
Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg
Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg

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

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,202 Previous Clinical Trials
4,178,246 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,207 Previous Clinical Trials
489,664 Total Patients Enrolled

Media Library

Mezagitamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05174221 — Phase 1
Kidney Disease Research Study Groups: Mezagitamab
Kidney Disease Clinical Trial 2023: Mezagitamab Highlights & Side Effects. Trial Name: NCT05174221 — Phase 1
Mezagitamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05174221 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the geographical scope of this trial's implementation?

"At present, five clinical trial sites are offering this medicine; these locations include Nampa, Evanston and Meridian. To mitigate travel costs for participants, it is essential to select the closest site available."

Answered by AI

Has Mezagitamab been previously tested in medical experiments?

"In 2019, American Oncology Partners of Maryland, PA began researching mezagitamab. Through the course of 4 completed trials and 4 ongoing ones, many located Nampa Idaho are culminating data on this drug's efficacy."

Answered by AI

Does this trial introduce a novel methodology to the field?

"Mezagitamab has been subject to clinical research since 2019. Initially, this medication was sponsored and trialed by Takeda with 50 participants in the first study year. After successfully completing Phase 1 drug approval, 4 live trials of Mezagitamab have opened across 18 countries and 58 cities worldwide."

Answered by AI

Has Mezagitamab's safety and efficacy been certified by the FDA?

"Evidence from Mezagitamab’s Phase 1 clinical trial indicates limited efficacy and safety data, thereby earning a score of 1."

Answered by AI

Are there any unfilled positions available in this clinical trial?

"Affirmative, the trial is open for enrollment. As per clinicaltrials.gov, this study was initially posted on November 9th 2022 and has since been amended. 16 participants are sought from 5 separate medical institutions."

Answered by AI

How many participants are currently recruited for this trial?

"This trial requires 16 candidates that meet the prerequisite conditions to participate. Recruitment is being conducted by Boise Kidney and Hypertension Institute - Frenova in Nampa, Idaho and Amicis Research Center, Vacaville in Evanston, Illinois."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Background Therapy
2022. "A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Background Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05174221.
~9 spots leftby Mar 2026
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