Long-term safety of sibeprenlimab injections in adults with IgA nephropathy
Tests sibeprenlimab injections for long-term safety in adults with IgA nephropathy, a kidney disease.
Plain-language title generated from the registry record
Registry title: Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)
Key facts
- Where
- Adelaide, Concord, Fitzroy, Garran, Kogarah, Liverpool, New Lambton Heights, Saint Leonards, and St Albans, AustraliaSee the 9 sites
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with IgA nephropathy who finished an earlier sibeprenlimab trial (417-201-00007 or VIS649-201) without safety concerns and could benefit from continued treatment, in the investigator's opinion.
- Age
- 18 years and older
- Sex
- All sexes
- Disease stage
- IgA nephropathy. People with nephrotic syndrome cannot join. Nephrotic-range protein in the urine alone (more than 3.5 g/day) is allowed.
- Earlier treatment
- Must have completed Trial 417-201-00007 (at least 20 of the 26 doses over 2 years and the end-of-trial visit) or Trial VIS649-201 (at least 9 of the 12 doses over 1 year and the end-of-trial visit). No systemic immunosuppressive therapy (for example steroids, complement inhibitors, mycophenolate, rituximab) currently or within 16 weeks before enrollment.
Main reasons for not taking part
- Did not complete Trial 417-201-00007 or VIS649-201
- Treatment-limiting side effects in those trials, or repeated failure to follow trial procedures
- Positive pregnancy test, or not agreeing to contraception rules
- Nephrotic syndrome, or a serious or unstable medical disorder, cirrhosis or ongoing malignancy
- Received any organ transplant, including bone marrow or stem cell transplant
Read by machine on 9 November 2026.
Where in Australia
- AdelaideAdelaide, AustraliaNo longer taking part
- ConcordConcord, AustraliaNo longer taking part
- FitzroyFitzroy, AustraliaNo longer taking part
- GarranGarran, AustraliaNo longer taking part
- KogarahKogarah, AustraliaNo longer taking part
- LiverpoolLiverpool, AustraliaNo longer taking part
- New Lambton HeightsNew Lambton Heights, AustraliaNo longer taking part
- Saint LeonardsSaint Leonards, AustraliaNo longer taking part
- St AlbansSt Albans, AustraliaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Trial code
- NCT05248659
- Record updated
- 5 May 2026
- Original description
To evaluate the long-term safety and tolerability of sibeprenlimab in subjects with IgANRead full original descriptionShow less
A Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy.
To evaluate the long-term safety and tolerability of sibeprenlimab in subjects with IgAN
Inclusion: Subjects who completed Trial 417-201-00007 (at least 20 of the 26 doses over a 2-year duration and the end-of-trial visit) or Trial VIS649-201 (at least 9 of the 12 doses over a 1-year duration and the end-of-trial visit) without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab for IgAN; Ability to provide written, informed consent prior to initiation of any trial-specific procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.
Exclusion: Subjects who have a positive pregnancy test result prior to receiving IMP; History of a previous hypersensitivity or severe allergic reaction with generalized urticaria, angioedema or anaphylaxis to any of the ingredients of the sibeprenlimab SC injection formulation; Subject has received an organ transplant (ie, solid or a bone marrow or hematologic stem cell transplantation); Subject is currently receiving, or has received within 16 weeks prior to enrollment, systemic immunosuppressive therapy (ie, steroids such as targeted release budesonide, complement inhibitors, mycophenolate, rituximab). Note: topical, ophthalmic, rectal, intra-articular, inhaled corticosteroids, and short courses of oral/intravenous steroids (<= 14 days) are allowed; Noncompliance, due to subject's repeated failure to follow trial procedures during the course of their participation in Trials 417-201-00007 and VIS649-201 (eg, subjects deemed to be noncompliant with the visit schedule, trial assessments, or treatment regimen). The medical monitor should be contacted if the investigator is unsure of a subject's eligibility; Subject has a history or current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune, rheumatologic, blood dyscrasias or other medical disorder, including psychiatric disorders, cirrhosis, or ongoing malignancy. History of minor skin cancers (not including melanoma) or surgically treated, limited cervical carcinomas (ie, carcinoma in situ) are not exclusionary; Subject has nephrotic syndrome, defined for this purpose as 24-hour urine protein > 3.5 g with concurrent hypoalbuminemia (serum albumin < 2.5 g/dL), hyperlipidemia (total cholesterol > 350 mg/dL), and edema. Subjects with isolated nephrotic range proteinuria (> 3.5 g/day) will be eligible; Subjects who have not completed participation in Trials 417-201-00007 or VIS649-201; Subjects with treatment-limiting AEs during Trials 417-201-00007 or VIS649-201 considered related to IMP per investigator judgement; Heterosexually active biological males or subjects of childbearing potential, or their partners, who do not agree to adhere to contraceptive requirements from the time of consent through the end of the subject's participation in the trial and an additional 90 days (biological male subjects) or 30 days (biological female subjects) thereafter; Biological male subjects who do not agree to avoid donation of sperm from the time of consent through the end of the subject's participation in the trial and an additional 90 days thereafter; Subject has a body mass index < 16 kg/m\^2.