EUCTR2005-004695-20-DE进行中（未招募）不适用
Randomized multicenter trial comparing Valganciclovir CMV prophylaxis versus pre-emptive therapy after renal transplantation using proteomics for monitoring of graft alteration - VIPP
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •1.Patient has received within the preceding 14 days a primary or secondary renal allograft from a liv-ing or cadaveric donor
- •2.Patient is IgG seropositive for CMV and has re-ceived an allograft from a CMV IgG seropositive or seronegative donor
- •3.Patient receives immunosuppression including a CNI (CsA or tacrolimus) and MMF (mycophe-nolate mofetil)
- •4.Patient is 18 years of age or older
- •5.Patient is willing to give written informed con-sent, written consent for data protection and will-ingness to participate and to comply with the study
- •6.Laboratory parameters: Patient has adequate he-matological and renal function defined as:
- •a)Leucocyte count >3,500 cells/?L
- •b)Platelet count >100,000 cells/?L
- •c)Hemoglobin >8.0 g/dL
- •d)Estimated creatinine clearance (calculated by the Cockcroft-Gault formula, see Section 6.1.2) of >10 ml/min with evidence of im-proving renal function
- •7.Patient agrees to utilize contraceptive methods throughout the study period and for 90 days fol-lowing discontinuation of the Study Drug. Male patients must agree to use condoms throughout the study period and for 90 days following discon-tinuation of the Study Drug.
- •8.Females of childbearing potential will have a negative pregnancy test at screening
- •9.Patient is able to tolerate oral medication within 14 days post transplantation. The day of comple-tion of transplant surgery is defined as Day 0 post transplantation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patient has active CMV infection (CMV PCR = 400 copies/ml)
- •2.Severe uncontrolled diarrhea or evidence of malab-sorbtion
- •3.Patients with malignancies or history of malig-nancy except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
- •4.Acute steroid resistant rejection episode since transplantation
研究者
相似试验
进行中（未招募）
不适用
Trial comparing Valganciclovir CMV prophylaxis versus pre-emptive therapy after renal transplantation using proteomics for monitoring of graft alteratioPrevention of cytomegalovirus (CMV) disease in kidney transplant recipientsMedDRA version: 17.0Level: PTClassification code 10023439Term: Kidney transplant rejectionSystem Organ Class: 10021428 - Immune system disordersEUCTR2005-004695-20-ATRoche Pharma AG300
已完成
不适用
A multi-center randomized controlled trial Comparing Standard Prednisolone therapy with Standard Prednisolone therapy + High-dose Mizoribine for the Treatment of early-relapsing steroid sensitive nephrotic syndrome in children (JSKDC05)Steroid sensitive nephrotic syndrome in childrenJPRN-UMIN000005103Japanese Study Group of Kidney Disease in Children120
已完成
3 期
A multi-center, randomized controlled trial comparing early versus elective colonoscopy in outpatients with acute lower gastrointestinal bleedingAcute lower gastrointestinal bleedingJPRN-UMIN000021129Graduate School of Medicine, The University of Tokyo162
已完成
不适用
Prenatal treatment of Lower Urinary Tract ObstructioISRCTN53328556niversity of Birmingham (UK)200
已完成
不适用
Efficacy and Safety of a Transient Ischaemic Attack (TIA) Electronic Support ToolTransient Ischaemic AttackStroke - IschaemicStrokeACTRN12611000792921Dr Annemarei Ranta40