Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy
- Conditions
- Health Condition 1: N00-N99- Diseases of the genitourinary system
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Subjects are required to meet the following inclusion criteria when assessed:
1) Subjects who completed Trial 417-201-00007 (at least 20 of the 26 doses and the
end-of-trial visit) or Trial VIS649-201 (at least 9 of the 12 doses 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.
2) Subject has eGFR = 20 mL/min/1.73 m2, calculated using the Chronic Kidney
Disease Epidemiology Collaboration (CKD-EPI) formula.
3) 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.
1) Subjects who have not completed participation in Trials 417-201-00007 or VIS649-201.
2) Subjects with treatment-limiting adverse events (AEs) during Trials 417-201-00007 or VIS649-201 considered related to IMP per investigator judgement that would preclude rollover into this trial.
3) 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.
4) Subjects who have a positive pregnancy test result prior to receiving IMP.
5) Heterosexually biological active 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.
6) Subjects must also agree not to donate sperm from the time of consent through the end of the subject’s participation in the trial and an additional 90 days thereafter.
7) 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.
8) 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.
9) History of a previous severe allergic reaction with generalized urticaria; angioedema or anaphylaxis.
10) Subject has a body mass index < 16 kg/m2.
11) Subject has received an organ transplant (ie, solid or a bone marrow or hematologic stem cell transplantation).
12) Subject is currently receiving, or has received within 16 weeks prior to enrollment, systemic immunosuppression (note: topical, ophthalmic, rectal, intra-articular, inhaled corticosteroids, and short courses of oral/intravenous steroids [= 14 days] are allowed).
13) Subject has participated in another interventional clinical trial (other than
Trials 417-201-00007 and VIS649-201) and received another investigational drug within 30 days prior to the administration of IMP or 5 half-lives from last investigational drug administration, whichever is longer.
14) Subject has any chronic infectious disease (eg, chronic urinary tract infection;
chronic sinusitis; bronchiectasis; active pulmonary or systemic tuberculosis; chronic viral hepatitis, such as hepatitis C or hepatitis B [defined as positive for hepatitis B surface antigen]; or human immunodeficiency virus [HIV] infection).
15) Subject has acute infectious disease at the time of screening.
16) Subject has Type 1 diabetes.
17) Subject has uncontrolled Type 2 diabetes, as evidenced by a screening hemoglobin A1c (HbA1c) value > 8%.
18) Subject has
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the long-term safety and tolerability of sibeprenlimab in subjects with IgAN.Timepoint: From baseline to the end-of-trial visit in Week 112.
- Secondary Outcome Measures
Name Time Method Annualized slope of Estimated Glomerular Filtration Rate(eGFR)Timepoint: Over 12 & 24 months;Proportion of Subjects with Clinical Remission as defined in the protocolTimepoint: At 12 & 24 months;Time to Progression of Chronic Kidney Disease, as defined in the protocolTimepoint: Over 24 months;Urine protein-creatinine ratio (uPCR) in a 24-hour collectionTimepoint: At 12 & 24 months