NCT05983770已完成2 期
AT-1501-K207: BESTOW: A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 85
- 主要终点
- eGFR at 12 months
研究概览
简要总结
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.
详细描述
This study is a randomized, multicenter, open-label, active control study to evaluate the safety and efficacy of AT-1501 compared with tacrolimus in the prevention of rejection in patients undergoing kidney transplantation. Up to 120 de novo kidney transplant recipients will receive rATG induction with corticosteroids (CS), and mycophenolate as maintenance therapy, and will be randomized 1:1 to receive either AT-1501 or tacrolimus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years of age
- •Recipient of their first kidney transplant from a living or deceased donor
- •Agree to comply with contraception requirements during and for at least 90 days after the last administration of study drug
排除标准
- •Induction therapy, other than study assigned rATG, planned as part of initial immunosuppressive regimen
- •Currently treated with any systemic immunosuppressive regimen, including immunologic biologic therapies
- •Currently treated with corticosteroids other than topical or inhaled corticosteroids
- •Will receive a kidney with an anticipated cold ischemia time of > 30 hours
- •Will receive a kidney from a donor that meets any of the following:
- •5a. Donation after Cardiac Death (DCD) criteria; Or
- •5b. Kidney Donor Profile Index (KDPI) of > 85%; Or
- •5c. Is blood group (ABO) incompatible
- •Medical conditions that require chronic use of systemic corticosteroids or other immunosuppressants
- •History of a thromboembolic event, known hypercoagulable state, or condition requiring long term anticoagulation
- •Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening
研究组 & 干预措施
Investigative
Experimental
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
干预措施: AT-1501 (Drug)
Comparator
Active Comparator
Tacrolimus administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter
干预措施: Tacrolimus (Drug)
结局指标
主要结局
eGFR at 12 months
时间窗: Assessed from date of transplant through Day 364 (Month 12)
Estimated Glomerular Filtration Rate (eGFR) at 12 months post-transplant
次要结局
- NODAT at 12 months post-transplant(Assessed from date of transplant through Day 364 (Month 12)
- The proportion of patient and graft survival at 12 months post-transplant(Assessed from date of transplant through Day 364 (Month 12))
- BPAR-free patient and graft survival at 12 months post-transplant(The proportion of BPAR-free patient and graft survival at 12 months post-transplant)
- BPAR at 12 months(Assessed from date of transplant through Day 364 (Month 12))
研究者
研究点 (85)
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相关资讯
Eledon Pharmaceuticals Completes Enrollment in Phase 2 BESTOW Trial of Tegoprubart for Kidney Transplant Rejection- Eledon Pharmaceuticals completed enrollment for its Phase 2 BESTOW trial of tegoprubart, an immunosuppression therapy, four months ahead of schedule.
- The BESTOW trial assesses tegoprubart's safety and efficacy in preventing organ rejection in kidney transplant recipients, compared to tacrolimus.
- The primary endpoint is graft function at 12 months post-transplant, measured by estimated glomerular filtration rate (eGFR).
- Top-line results from the BESTOW trial are anticipated in the fourth quarter of 2025, marking a potential advancement in immunosuppression therapy.2 years agoEledon's Tegoprubart Shows Superior Kidney Function Preservation in Phase 1b Transplant Trial- Eledon Pharmaceuticals reported updated Phase 1b trial data for tegoprubart, an anti-CD40L antibody, showing superior kidney function preservation with mean eGFR of 70.5 mL/min/1.73m² compared to standard care's 50 mL/min/1.73m².
- The immunosuppressive therapy demonstrated favorable safety profile with no cases of hyperglycemia, diabetes, or tremor commonly associated with calcineurin inhibitors, though three patients discontinued due to adverse events.
- Two patients completing 12 months of treatment maintained excellent kidney function with eGFRs above 90 mL/min/1.73m², supporting tegoprubart's potential as next-generation immunosuppression for kidney transplant recipients.
- The company continues enrollment in Phase 2 BESTOW trial with completion anticipated by year-end, positioning tegoprubart to potentially replace current standard-of-care calcineurin inhibitors.2 years ago