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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Takeda Development Center Americas Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

16 Dec 2025 → ongoing

Decision date (initial)

2025-09-22

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Takeda Development Center Americas, Inc.

External identifiers

EU CT number

2025-520825-19-00

ClinicalTrials.gov

NCT06963827

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic

To evaluate the effects of mezagitamab on proteinuria levels at Week 36 in participants who are receiving mezagitamab compared with those receiving placebo.

Secondary objectives 5

1. 01.To determine long-term effect of mezagitamab on the change from baseline in eGFR measured at Week 52 and Week 104, sustained decline in eGFR of ≥30%, and kidney failure composite clinical endpoint over 2 years.
2. 02. To assess the durability of proteinuria reduction subsequent to mezagitamab administration.
3. 03. To assess the resolution of hematuria over time.
4. 04. To determine immunogenicity of mezagitamab in trial participants who are receiving mezagitamab.
5. 05. To characterize the PK profile of mezagitamab in trial participants who are receiving mezagitamab.

Conditions and MedDRA coding

IgAN is Primary Immunoglobulin A Nephropathy (IgAN) (also known as Berger's disease)

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda’s data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 01. Urine protein creatinine ratio (UPCR) ≥0.8 g/g or urine protein excretion (UPE) ≥1 g/day by 24-hour urine collection.
2. 02. eGFR >30 mL/min/1.73m2 at screening based on the Chronic Kidney Disease-Epidemiology Formula
3. 03. Diagnosis of primary IgAN supported by a renal biopsy report that is dated more recently than 10 years before the signing of informed consent
4. 04. Resting blood pressure ≤150 mmHg systolic and ≤100 mmHg diastolic.

Exclusion criteria 8

1. 01. Kidney biopsy exhibiting significant concomitant renal disease other than IgAN
2. 02. Evidence of secondary IgAN.
3. 03. Evidence of rapidly progressive glomerulonephritis (loss of ≥ 50% eGFR within prior 3 months before consent
4. 04. Nephrotic syndrome (24-hr proteinuria >3.5 g/day or hypoalbuminemia (<3.0 g/dL) with or without peripheral edema).
5. 05. Immunosuppressant treatment within 6 months of consent.
6. 06. Anti-CD20 treatment if either within 6 months of consent or 6-12 months if CD19+ count is
7. 07. Within 4 months of the screening visist, use of either a) Systemic corticosteroids use at average dose ≥ 40mg prednisone or equivalent or higher for more than 14 days or b) use of oral budesonide delayed release capsules
8. 08. Specific infections with respective timeframes

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in proteinuria at Week 36 as assessed by a UPCR calculated from a 24-hour urine collection.

Secondary endpoints 13

1. 01. The change from baseline in eGFR at Week 52.
2. 02. The rate of change in eGFR from baseline to Week 52; eGFR total slope at Week 52.
3. 03. The change from baseline in eGFR at Week 104.
4. 04. The rate of change in eGFR from baseline to Week 104; eGFR total slope at Week 104.
5. 05. Time from baseline to the first occurrence of sustained decline in eGFR of ≥30% from baseline over at least 4 weeks.
6. 06. Time from baseline to the first occurrence of any of the following outcomes based on the kidney failure composite endpoint: sustained decline in eGFR of ≥30% from baseline over at least 4 weeks; sustained eGFR <15 mL/min/1.73 m2 over at least 4 weeks; initiation of maintenance dialysis defined as dialysis performed for at least 4 weeks; receipt of kidney transplant; or death from kidney failure (Levin et al. 2020).
7. 07. Change from baseline in proteinuria levels as assessed by UPCR calculated from a 24-hour urine collection at Week 104.
8. 08. Resolution of hematuria at Week 36.
9. 09. Resolution of hematuria at Week 52.
10. 10. Resolution of hematuria at Week 104
11. 11. Incidence of ADA.
12. 12. Incidence of NAb.
13. 13. The serum concentrations of mezagitamab during and after intervention.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Takeda Development Center Americas Inc.

Sponsor organisation

Takeda Development Center Americas Inc.

Address

500 Kendall Street

City

Cambridge

Postcode

02142-1108

Country

United States

Scientific contact point

Organisation

Takeda Development Center Americas Inc.

Contact name

Takeda

Public contact point

Organisation

Takeda Development Center Americas Inc.

Contact name

Takeda

Third parties 9

Locations

12 EU/EEA countries · 50 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 303 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications