CTRI/2024/02/062883招募中2 期
A Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety,Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjectswith Immunoglobulin A Nephropathy
未提供0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •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.
排除标准
- •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
研究者
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