CTIS2022-501677-39-00招募中1 期
A Prospective, Open-label, Multicenter, Randomized Study to Evaluate the Benefits and Risks ofConversion of Existing Adolescent Renal Allograft Recipients Aged 12 to Less Than 18 Years ofAge to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of aCalcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications - IM103402
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 109
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
- 0 至 17（—）
- 性别
- All
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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