A Study to Assess the Effects of Zigakibart on IgA Nephropathy.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-20

Study Completion Date

2030-10-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Identification and Characterisation of IgA With Nephritogenic Potential in IgA Deposition Nephropathies (Rep-IgAN)

NCT07295808

Kidney Disease

RECRUITING NA

Effect of Statins on IgG, IgA and IgM Level in Chronic Hemodialysis Patients

NCT01305317

Chronic Kidney Disease

COMPLETED NA

Multicenter Study Evaluating the Performance of the Assay of Anti-hinge Region Antibodies in the Diagnosis of Progressive Forms of IgA Nephropathy

NCT02526966

IgA Nephropathy

COMPLETED NA

Focus on Levels of Awareness and Perceptions Regarding hsCRP in Identifying Systemic Inflammation in ASCVD, CKD and Heart Failure Management

NCT07160829

Atherosclerotic Cardiovascular Disease Heart Failure Chronic Kidney Disease

COMPLETED

Study of Genetic Anomalies of Complement Related Proteins in Patients With IgA Glomerulonephritis

NCT00004305

IGA Glomerulonephritis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is an open-label multicenter study where participants are randomized into one of two groups, where the only difference between the groups is the on-treatment biopsy time point, end of the first year of treatment (Group A) or at the end of the second year of treatment (Group B).

The total study duration for each participant may be up to 125 weeks, including the maximum screening period (8 weeks), the treatment period (104 weeks), and the safety follow up period (13 weeks).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Immunoglobulin A Nephropathy (IgAN)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Participants will be randomly assigned in a ratio of 1:1 to undergo the on-treatment biopsy at one of two possible timepoints

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

zigakibart

zigakibart injections every second week for two years

Group Type EXPERIMENTAL

zigakibart

Intervention Type BIOLOGICAL

zigakibart 600 mg sc injections every second week for 104 weeks (2 years)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

zigakibart

zigakibart 600 mg sc injections every second week for 104 weeks (2 years)

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Primary IgAN, confirmed by kidney biopsy, within 5 years prior to Screening
* eGFR ≥45 mL/min/1.73 m2, based on the 2021 CKD-EPI equation, at Screening
* Persistent proteinuria, defined as either

* Total Urine Protein ≥0.5 g/day or UPCR ≥0.5 g/g in a 24-hour urine collection, at Screening, despite maximally tolerated dose or poorly tolerated supportive therapy or
* IgAN diagnosis \<6 months prior to Screening with Total Urine Protein \>1.5 g/day or UPCR \>1.5 g/g in a 24-hour urine collection, at the time of clinical presentation or diagnosis
* Body weight ≥45 kg and body mass index (BMI) ≤35.0 kg/m2, at Screening

Exclusion Criteria

* Secondary forms of IgAN, as determined by the Investigator, diagnosis of IgA vasculitis, or any other nephropathy or chronic urinary tract disorder
* Total IgG \<6.0 g/L at screening
* Any chronic urinary tract disorder, including but not limited to retention, incontinence, and/or recurrent urinary tract infections
* Untreated hypertension or uncontrolled hypertension despite treatment (i.e., resistant hypertension)
* Treatment with complement pathway inhibitors, mycophenolic acids, systemic calcineurin inhibitors or corticosteroids, immunosuppressive or immunomodulatory agents within 12 months prior to screening
* Acute kidney injury (AKI), defined by AKI network criteria, within 4 weeks prior to screening
* Current treatment with anti-APRIL monoclonal antibodies or dual APRIL/BAFF inhibitors or past treatment of the same at any time for \>3 consecutive months prior to screening
* Planned initiation of, or recently (within 24 weeks) initiated, treatment with glucagon-like peptide-1 agonists at screening

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No