2025-521521-33-00招募中3 期
A seamless Phase 2/3 randomized, open-label study to investigate efficacy and safety of frexalimab versus tacrolimus in adult kidney transplant recipients
Sanofi-Aventis Recherche & Developpement58 个研究点 分布在 11 个国家目标入组 269 人开始时间: 2026年3月17日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 269
- 试验地点
- 58
研究概览
简要总结
To demonstrate noninferiority of frexalimab as compared to tacrolimus in preventing kidney graft rejection
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participants who are scheduled to receive their first kidney transplant from a living or deceased donor.
- •Participants with low to moderate immunological risk.
排除标准
- •Deceased donor kidney graft qualified as expanded criteria donor or donor after cardiac death.
- •Positive T or B cell crossmatch, or positive virtual crossmatch per local practice at screening.
- •Participants receiving a kidney graft from HLA-identical living-related donors, or have current or previous solid organ, cell, or multi-organ transplantation, or paired kidney transplantation.
- •Participants whose primary causes of ESKD are idiopathic FSGS, C3 glomerulopathy, lupus nephritis, or thrombotic microangiopathy
- •Evidence of active or latent TB, HIV, HBV or HCV infection.
- •Participants who have known genetically predisposed thrombophilia, have history of thromboembolic events, or who need long-term anti-coagulation therapy.
- •Participants who have severe medical co-morbidities, active infection, or severely limited life expectancy due to underlying medical conditions that are generally precluded from kidney transplant.
研究组 & 干预措施
Prograf 0,5 mg Hartkapseln
Comparator
干预措施: Prograf 0,5 mg Hartkapseln (Drug)
Prograft 1 mg capsules, hard
Comparator
干预措施: Prograft 1 mg capsules, hard (Drug)
Prograft 5 mg capsules, hard
Comparator
干预措施: Prograft 5 mg capsules, hard (Drug)
Frexalimab
Test
干预措施: Frexalimab (Drug)
Prograf 5 mg Hartkapseln
Comparator
干预措施: Prograf 5 mg Hartkapseln (Drug)
Prograft 0,5 mg capsules, hard
Comparator
干预措施: Prograft 0,5 mg capsules, hard (Drug)
Prograf 1 mg Hartkapseln
Comparator
干预措施: Prograf 1 mg Hartkapseln (Drug)
研究者
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Recherche & Developpement
研究点 (58)
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