2023-509936-25-00招募中2 期
A multi-cohort, randomized, Phase 2, open-label study to assess the preliminary efficacy, safety, and pharmacokinetics of BIVV020 for prevention and treatment of antibody- mediated rejection in adult kidney transplant recipients
Sanofi-Aventis Recherche & Developpement13 个研究点 分布在 5 个国家目标入组 40 人开始时间: 2024年6月12日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 13
- 主要终点
- Cohort A: Treatment failure rate
研究概览
简要总结
• Cohort A: To evaluate the efficacy of BIVV020 in prevention of AMR • Cohort B: To evaluate the efficacy of BIVV020 in treatment of active AMR
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participant intended to receive SOC therapy per Investigator’s judgment and local practice. Cohort A: Participants with chronic kidney disease who will receive a kidney transplant from a living or deceased donor . Cohort B: Participants who are kidney transplant recipients diagnosed with active AMR. BMI ≤ 40 kg/m
- •Contraceptive use by women during the treatment period, and for at least 49 weeks after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment period visit (SOC arm participant). Contraceptive use by men during the treatment period, and for at least 49 weeks after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment period visit (SOC arm participant).
- •Cohort A: Participants with chronic kidney disease who will receive a kidney transplant from a living or deceased donor . Cohort B: Participants who are kidney transplant recipients diagnosed with active AMR.
- •BMI ≤ 40 kg/m
- •Contraceptive use by women during the treatment period, and for at least 49 weeks after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment period visit (SOC arm participant).
- •Contraceptive use by men during the treatment period, and for at least 49 weeks after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment period visit (SOC arm participant).
排除标准
- •Participants who are ABO incompatible with their donors.
- •Participants with known active ongoing infection as per below: a) Positive HIV. b) Positive HBV. c) HCV with detectable HCV RNA. d) Within 4 weeks of first study intervention: any serious infection, or any active bacterial infection i, or any other infection which is clinically significant in the option of the Investigator, unless it can be confirmed that infection was cleared at least 3 days prior to first study intervention
- •History of active tuberculosis (TB) regardless of treatment.
- •Participants with clinical diagnosis of systemic lupus erythematosus (SLE).
- •Prior treatment with complement system inhibitor within 5 times the half-life.
- •Current enrollment in any other clinical study where the last investigational study treatment administration was within 5 half-lives from study intervention initiation.
结局指标
主要结局
Cohort A: Treatment failure rate
Cohort A: Treatment failure rate
Cohort B: AMR resolution rate
Cohort B: AMR resolution rate
次要结局
- Cohort A: Treatment failure rate
- Cohort B: AMR resolution rate
- Change in renal function from baseline per central laboratory assessment of estimated glomerular filtration rate (eGFR) from serum creatinine using Modification of Diet in Renal Disease equation (MDRD)
- Change in renal function from baseline per central laboratory assessment using protein: creatinine ratio
- Change in allograft histopathology Banff score
- Graft survival as predicted by iBOX
- Assessment of adverse events (AEs)
- Change in systemic lupus erythematosus (SLE) panel
- Plasma exposure of BIVV020 assessing pharmacokinetic parameter Cmin
- Plasma exposure of BIVV020 assessing pharmacokinetic parameter AUC
- Number of participants with anti-BIVV020 antibodies
研究者
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Recherche & Developpement
研究点 (13)
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