NL-OMON52226招募中3 期
A Prospective, Open-label, Multicenter, Randomized Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Renal Allograft Recipients Aged 12 to Less Than 18 Years of Age to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications - IM103-402
Bristol-Myers Squibb0 个研究点目标入组 3 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3
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
- 年龄范围
- 12 至 17（—）
入选标准
- •- Male and females between 12 to less than 18 years of age
- •- Documented EBV seropositivity prior to transplant and randomization
- •- Receiving a stable regimen of a CNI with a mycophenolate with or
- •without concomitant corticosteroids for > 1 calendar month prior to
- •randomization
- •- Stable renal function 12 weeks prior to screening based upon
- •investigator assessment and protocol-defined criteria for eGFR and proteinuria
排除标准
- •- No treatment for biopsy-proven acute rejection (BPAR) of any degree
- •of severity within 6 calendar months prior to enrollment.
- •- No history of biopsy confirmed antibody mediated rejection or Banff
- •Grade IIA or higher acute cellular rejection with the current transplant
研究者
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