EUCTR2018-000237-12-FR进行中（未招募）1 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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
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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