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临床试验/NCT00114777
NCT00114777已完成3 期

Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial - Extended Criteria Donors (BENEFIT-EXT)

Bristol-Myers Squibb29 个研究点 分布在 2 个国家目标入组 595 人开始时间: 2005年2月最近更新:
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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
595
试验地点
29
主要终点
Percentage of Participants Who Survived With a Graft at 12 Months Post-Transplant
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended criteria.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Subject is a first-time recipient of a kidney transplant from a deceased donor.
  • •Specific donor criteria

排除标准

  • •Donor age <10 years
  • •Subjects receiving a concurrent solid organ or cell transplant (lung, heart, etc.)
  • •Subjects with a positive T-cell lymphocytotoxic crossmatch.
  • •Subjects who are positive for Hepatitis B or C, or HIV
  • •Active tuberculosis
  • •History of cancer in the last 5 years
  • •History of substance abuse
  • •Specific laboratory results are exclusionary
  • •Mammography suspicious for cancer
  • •Allergy to iodine
  • •For Long-term extension study-Subjects who have completed three years of study treatment (through Week 156)

研究组 & 干预措施

Cyclosporin A

Active Comparator

干预措施: Cyclosporin A (Drug)

Belatacept Less Intensive Regimen (LI)

Experimental

干预措施: Belatacept Less Intensive Regimen (LI) (Drug)

Belatacept More Intensive Regimen (MI)

Experimental

干预措施: Belatacept More Intensive Regimen (MI) (Drug)

结局指标

主要结局

Percentage of Participants Who Survived With a Graft at 12 Months Post-Transplant

时间窗: Month 12 post-transplant

Participant and graft survival at 12 months was summarized within each treatment group. Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine ≥ 6.0 mg/dL (530 μmol/L) as determined by central laboratory for ≥4 weeks or 56 or more consecutive days of dialysis.

Percentage of Participants With a Measured Glomerular Filtration Rate (GFR) <60 mL/Min Per 1.73 m^2 at Month 12 or a Decrease in Measured GFR >=10 mL/Min Per 1.73 m^2 From Month 3 to Month 12

时间窗: From Month 3 to Month 12

GFR was assessed using a true measure of glomerular filtration via non-radiolabeled iothalamate clearance test using a validated procedure.

次要结局

  • Measured Glomerular Filtration Rate (GFR) by Month 12 and 24(At Month 12 and Month 24)
  • Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months(Baseline and Months 12, 24 and 36)
  • Percentage of Participants With Chronic Allograft Nephropathy (CAN) at Month 12(At Month 12)
  • Change in Calculated GFR at Months 12, 24, 36 and 84(Baseline and Months 12, 24, 36 and 84)
  • Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months.(Months 12, 24 and 36)
  • Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months(Months 12, 24 and 36)
  • Mean Framingham Risk Score From Baseline to Months 12, 24 and 36(Baseline and Months 12, 24 and 36)
  • Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months(Months 12, 24 and 36)
  • Percentage of Participants Who Survived With a Graft at 24 and 36 Months Post-Transplant(Month 24 and Month 36 post-transplant)
  • Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36(Months 12, 24 and 36)
  • Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months(Months 6, 12, 24, 36 and 84)
  • Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36(Months 12, 24 and 36)
  • Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84(Months 6, 12, 24, 36 and 84)
  • Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.(Months 6, 12, 24 and 36)
  • Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84(Months 6, 12, 24, 36 and 84)
  • Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36(Baseline and Months 12, 24 and 36)
  • Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months(Day 1 to Month 36)
  • Number of Participants With Laboratory Test Abnormalities up to 36 Months(Day 1 to Month 36)
  • Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36(Day 1 to Month 36)
  • Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84(Day 1 to Month 84)
  • Percentage of Participants With Graft Loss or Death to Month 84(Randomization to date of death, up to 84 months)

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (29)

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