A Randomized Trial Comparing Valcyte CMV Prophylaxis Versus Pre-emptive Therapy After Renal Transplantation Using Proteomics for Monitoring of Graft Alteration
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 299
- 主要终点
- Urine Proteomic Pattern at Month 12
研究概览
简要总结
This 2 arm study will compare the efficacy of 100 days of Valcyte (900mg po daily) prophylaxis with that of no prophylaxis, under the condition of pre-emptive therapy of active CMV infection, in CMV positive renal transplant recipients. The influence of the two prevention concepts on the occurrence of direct and indirect effects of active CMV infections will be compared. The anticipated time on study treatment is 3 months-1 year, and the target sample size is 100-500 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •primary or secondary renal allograft within preceding 14 days;
- •IgG seropositive for CMV;
- •receiving immunosuppressive therapy.
排除标准
- •active CMV infection;
- •current/history of malignancy;
- •acute steroid resistant rejection episode since transplantation.
研究组 & 干预措施
Valganciclovir Cytomegalovirus (CMV) Prophylaxis
干预措施: Valganciclovir CMV Prophylaxis (Drug)
Pre-emptive CMV Therapy
干预措施: Valganciclovir (Pre-emptive CMV Therapy) (Drug)
Pre-emptive CMV Therapy
干预措施: Ganciclovir (Drug)
结局指标
主要结局
Urine Proteomic Pattern at Month 12
时间窗: Up to 12 months
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. Urine proteomic pattern was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Percentage of Participants With Graft Loss at Month 84
时间窗: Up to 84 months
Percentage of Participants With Active Cytomegalovirus (CMV) Infection Within 12 Months
时间窗: Up to 12 months
Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
Percentage of Participants With CMV Disease Within 12 Months Including CMV Syndrome and Tissue Invasive Disease
时间窗: Up to 12 months
CMV disease comprises the two components of CMV syndrome as well as CMV tissue invasive disease. CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced \>50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN). CMV tissue invasive disease was defined as viremia according plasma PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid \[DNA\] by immunostaining or hybridization, respectively), cerebral spinal fluid \[CSF\]) and/or relevant symptoms or signs of organ dysfunction.
次要结局
- Percentage of Participants With Leukopenia Within 12 Months(Up to 12 months)
- Percentage of Participants With Any Opportunistic Infection Within 12 Months(Up to 12 months)
- Percentage of Participants With Post-Transplant Diabetes Mellitus(Up to 12 months)
- Percentage of Participants With Active CMV Infections Not Responding to Valganciclovir or IV Ganciclovir Treatment(Up to 12 months)
- Percentage of Participants With Graft Survival at Month 12(Up to 12 months)
- Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84(From Month 24 to Month 84)
- Proteomics Parameter: CKD273(Up to 12 months)
- Proteomics Parameter: CMV(Up to 12 months)
- Proteomics Parameter: Nephropathy(Up to 12 months)
- Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84(From Month 24 to Month 84)
- Time to Occurrence of First Viremia Within 12 Months(Up to 12 months)
- Creatinine Clearance at Month 12(Up to 12 months)
- Relationship Between Proteomics Pattern and Graft Survival(Up to 12 months)
- Relationship Between Proteomics Pattern and Participant Survival(Up to 12 months)
- Percentage of Participants Surviving at Month 12(Up to 12 months)
- Percentage of Participants With Neutropenia Within 12 Months(Up to 12 months)
- Percentage of Participants With CMV Syndrome Within 12 Months(Up to 12 months)
- Percentage of Participants With CMV Tissue Invasive Disease Within 12 Months(Up to 12 months)
- Viral Burden at Viremia(Up to 12 months)
- Days of Hospitalization(Up to 12 months)
- Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84(From Month 24 to Month 84)
- Percentage of Participants With at Least One Treated and Biopsy-Proven Acute Rejection Episode Within 12 Months(Up to 12 months)
- Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84(From Month 24 to Month 84)
- Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84(From Month 24 to Month 84)
- Number of Participants Who Died From Months 24 to Month 84(From Month 24 to Month 84)
- Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84(From Month 24 to Month 84)
- Creatinine Clearance at Month 24 and Every 12 Months up to Month 84(From Month 24 to Month 84)
- Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84(From Month 24 to Month 84)
- Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84(From Month 24 to Month 84)
- Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84(From Month 24 to Month 84)
- Kaplan-Meier Estimate of the Percentage of Participants (With Versus Without Active CMV Infection) on Pre-emptive CMV Therapy With First Occurrence of Graft Loss at Month 84(Up to 84 months)
- Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84(From Month 24 to Month 84)
- Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84(From Month 24 to Month 84)
- Number of Participants Who Had Lost Their Transplant up to Month 84(From Month 24 to Month 84)
- Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84(From Month 24 to Month 84)
- Kaplan-Meier Estimate of the Percentage of Participants (With Versus Without Active CMV Infection) on Valganciclovir CMV Prophylaxis With First Occurrence of Graft Loss at Month 84(Up to 84 months)
- Number of Participants Who Had Lost Their Transplant or Died up to Month 84(From Month 24 to Month 84)
- Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84(From Month 24 to Month 84)