NCT01820572已完成3 期
Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based Immunosuppression
Bristol-Myers Squibb62 个研究点 分布在 1 个国家目标入组 446 人开始时间: 2013年3月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 446
- 试验地点
- 62
- 主要终点
- Percentage of Participants Who Survive With a Functional Graft at 24 Months
研究概览
简要总结
The primary purpose is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-60 months after kidney transplant.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, ages 18-75 inclusive
- •Adult recipients of a renal allograft from a living donor or a deceased donor between 6-60 months prior to enrollment
- •Receiving a stable (≥1 month) regimen of Calcineurin inhibitor (CNI) [Cyclosporine A (CsA) or Tacrolimus (TAC)] with Mycophenolate mofetil (MMF) or Enteric Coated Mycophenolate Sodium (EC-MPS)/Mycophenolic acid (MPA), and corticosteroids
- •Stable renal function for 12 weeks prior to enrollment without new onset proteinuria
- •Calculated glomerular filtration rate (cGFR) ≥30 and ≤75 mL/min/1.73 m2 [Modification of Diet in Renal Disease study (MDRD) 4-formula]
排除标准
- •Recipients with Epstein-Barr virus (EBV) serostatus negative or unknown
- •History of acute rejection (AR) within 3 months prior to enrollment
- •History of antibody mediated rejection
- •Positive T-cell lymphocytotoxic cross match
- •Proteinuria >1 g/day or >0.5 g/day if diabetic
研究组 & 干预措施
Belatacept
Experimental
Belatacept 5 mg/kg intravenous 30 minute infusion on Days 1, 15, 29, 43, 57 then every 28 days for 24 months
干预措施: Belatacept (Drug)
CNI
Active Comparator
Tacrolimus 4-11 ng/mL tablet orally according to package insert for 24 months
Cyclosporine 50-250 ng/mL tablet orally according to package insert for 24 months
干预措施: Tacrolimus (Drug)
CNI
Active Comparator
Tacrolimus 4-11 ng/mL tablet orally according to package insert for 24 months
Cyclosporine 50-250 ng/mL tablet orally according to package insert for 24 months
干预措施: Cyclosporine (Drug)
结局指标
主要结局
Percentage of Participants Who Survive With a Functional Graft at 24 Months
时间窗: at 24 Months
Percentage of participants who survive with a functional graft at 24 months post-randomization
次要结局
- Percentage of Participants Who Survive With a Functional Graft at 12 Months(at 12 Months)
- Number of Participants With a Biopsy Proven Acute Rejection (BPAR)(at 12 and 24 Months)
- Number of Participants With Varying Severity of BPAR(at 12 and 24 months)
- Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Percent Change(at 12 and 24 months)
- Percentage of Participants With > 5% and >10% Improvement Over Baseline cGFR(at 12 and 24 Months)
- Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Adjusted Change(at 12 and 24 months)
- Mean Urine Protein/ Creatinine Ratio (UPCR)(Up to 24 Months)
- Mean Change From Baseline in Systolic and Diastolic Blood Pressure(at 12 and 24 months)
- Number of Antihypertensive Medications Used to Control Hypertension(at baseline, 12 and 24 Months)
- Number of Participants With Donor Specific Antibodies (DSA)(at baseline, 12 and 24 months)
- Mean Calculated Glomerular Filtration Rate (cGFR)(up to 24 months)
- Slope Analysis of cGFR(at 12 and 24 Months)
- Slope Analysis of 1/Serum Creatinine(at 12 and 24 Months)
- Mean Number of Symptom Occurrence and Symptom Distress(up to 12 Months)
- Number of Participants With an Adverse Event of Special Interest(24 Months)
- Number of Participants With Marked Laboratory Abnormalities(24 Months)
- Mean Change From Baseline in Vital Signs: Heart Rate(at 12 and 24 months)
研究者
研究点 (62)
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