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New treatment option for Kidney Diseases
Official title Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.
ClinicalTrials.gov ID: NCT06858319
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 kidney diseases.
Also referred to as FUB523; BION-1301.
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 this study is to determine if zigakibart is safe and effective for long-term use in patients with immunoglobulin A nephropathy (IgAN). This is an extension study for patients who have already completed an another zigakibart study.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, 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
- Signed informed consent must be obtained prior to participation in the OLE study.
- Completion of the parent study (both participants assigned to receive the investigational product and placebo) as defined by the respective protocol.
- Per Investigator's clinical judgment, the participant may benefit from receiving open-label treatment of zigakibart 600 mg s.c. Q2W.
You likely can't join if
- Participants who prematurely withdrew from zigakibart parent studies in IgAN for any reason.
- Participants who at the time of first study treatment administration in the OLE are receiving chronic dialysis (≥30 days) or who require kidney...
- Acute kidney injury (AKI), defined by AKIN criteria (Mehta et al 2007) within 4 weeks of first study treatment administration in the OLE study.
- Clinical suspicion or diagnosis of rapidly progressive glomerulonephritis (RPGN), defined by KDIGO guidelines, or another glomerulopathy at the time...
- Received a live vaccination within 12 weeks prior to first study treatment administration in the OLE study or plan to have a live vaccination within...
- Use of systemic corticosteroid therapy (including budesonide) or other immunosuppressive therapy such as but not limited to mycophenolate...
See the full eligibility criteria
- Signed informed consent must be obtained prior to participation in the OLE study.
- Completion of the parent study (both participants assigned to receive the investigational product and placebo) as defined by the respective protocol.
- Per Investigator's clinical judgment, the participant may benefit from receiving open-label treatment of zigakibart 600 mg s.c. Q2W.
- Participants who prematurely withdrew from zigakibart parent studies in IgAN for any reason.
- Participants who at the time of first study treatment administration in the OLE are receiving chronic dialysis (≥30 days) or who require kidney transplantation.
- Acute kidney injury (AKI), defined by AKIN criteria (Mehta et al 2007) within 4 weeks of first study treatment administration in the OLE study.
- Clinical suspicion or diagnosis of rapidly progressive glomerulonephritis (RPGN), defined by KDIGO guidelines, or another glomerulopathy at the time of first study treatment administration in the OLE study.
- Received a live vaccination within 12 weeks prior to first study treatment administration in the OLE study or plan to have a live vaccination within 6 months after the last dose of study treatment.
- Use of systemic corticosteroid therapy (including budesonide) or other immunosuppressive therapy such as but not limited to mycophenolate, azathioprine, cyclosporine, tacrolimus, cyclophosphamide, etc., and herbs such...
- Current severe infection at the time of first study treatment in the OLE study or history of recurrent, severe, infections as determined by the Investigator.
- Newly diagnosed positive serology for hepatitis A virus IgM antibodies (anti-HAV IgM), hepatitis B surface antigen (HBsAg), detectable hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibodies (participants who...
- Newly diagnosed malignancy (participants with basal cell carcinoma that was completely resected or curatively treated cervical carcinoma in situ or low-risk prostate cancer (i.e., Gleason score \< 7 and prostate...
- Pregnancy or breastfeeding or intent to become pregnant or to donate sperm during the study period and until 24 weeks after last dose.
- History or evidence of any other clinically significant medical or psychiatric disorder, condition, disease, or laboratory finding that, in the discretion of the Investigator, constitutes an uncertain or unfavorable...
- Confirmed IgG levels \< 3 g/L prior to first study treatment administration in the OLE study.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, from menarche until becoming post-menopausal unless they are using highly effective methods of contraception (failure...
- Sexually active males unwilling to use a highly effective methods of contraception during intercourse while taking study treatment and for 24 weeks after stopping study treatment. In addition, male participants must not...
- Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not...
- Bilateral oophorectomy with or without hysterectomy, total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of...
- Bilateral tubal occlusion, bilateral tubal ligation (at least six weeks before taking study treatment).
- Sterilization (vasectomy) of male partner(s) of the female participant at least 6 months prior to first study treatment provided partner(s) has(have) received medical confirmation of surgical success.
- Use of hormonal contraception methods:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal or transdermal.
- Progestogen-only hormonal contraception (where inhibition of ovulation is not the primary or only mode of action): oral, injectable or implantable.
- Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS). In case of use of hormonal contraception, women should have been stable on the same method for a minimum of 3 months before taking study...
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Orlando, Florida, United States
- Clifton Park, New York, United States
- New York, New York, United States
- Brentwood, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Caba, Buenos Aires, Argentina
- La Plata, Buenos Aires, Argentina
- Buenos Aires, Buenos Aires F.D., Argentina
- Catamarca, Catamarca Province, Argentina
- Santa Fe, Argentina
- Kogarah, New South Wales, Australia
- Toronto, Ontario, Canada
- Kuantan, Pahang, Malaysia
- Kuala Lumpur, Malaysia
- Cheonan, Chungcheongnam-do, South Korea
- Guri-si, Gyeonggi-do, South Korea
- Seongnam-si, Gyeonggi-do, South Korea
- Seoul, Seoul, South Korea
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; Orlando, Florida, United States; Clifton Park, New York, United States; New York, New York, United States; Brentwood, Tennessee, United States; Dallas, Texas, United States and 14 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.