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New treatment option for Immunoglobulin A Nephropathy (IgAN)
Official title A Study to Assess the Effects of Zigakibart on IgA Nephropathy.
ClinicalTrials.gov ID: NCT07146906
What this study is testing
What is zigakibart?
zigakibart is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for immunoglobulin a nephropathy (igan).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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...
- IgAN diagnosis \ 1.5 g/day or UPCR \>1.5 g/g in a 24-hour urine collection, at the time of clinical presentation or diagnosis
You likely can't join if
- 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
- An average systolic blood pressure \>150 mmHg or average diastolic blood pressure \>90 mmHg based on three measurements at Screening
- Treatment with complement pathway inhibitors, mycophenolic acids, systemic calcineurin inhibitors or corticosteroids, immunosuppressive or...
- Acute kidney injury (AKI), defined by AKI network criteria, within 4 weeks prior to screening
See the full eligibility 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 \ 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
- 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
- An average systolic blood pressure \>150 mmHg or average diastolic blood pressure \>90 mmHg based on three measurements at Screening
- 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 Other protocol-defined inclusion/exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Acworth, Georgia, United States
- Iowa City, Iowa, United States
- Edina, Minnesota, United States
- Serra, Espírito Santo, Brazil
- Botucatu, São Paulo, Brazil
- Beijing, China
- Shanghai, China
- Munich, Bavaria, Germany
- Hanover, Germany
- Mainz, Germany
- Ranica, BG, Italy
- Brescia, BS, Italy
- Pavia, PV, Italy
- Kawasaki, Kanagawa, Japan
- Miyazaki, Japan
- Lodz, Poland
- Opole, Poland
- Seoul, Seoul, South Korea
- Seoul, South Korea
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Acworth, Georgia, United States; Iowa City, Iowa, United States; Edina, Minnesota, United States; Serra, Espírito Santo, Brazil; Botucatu, São Paulo, Brazil and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.