CTRI/2018/06/014356已完成1 期
Viral infections post renal transplantation: a pilot study to compare low dose vs standard dose valganciclovir prophylactic strategies for cytomegalovirus in renal transplant recipients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients undergoing renal transplant during period of January 2018 to December 2018 with
- •1)>= 16 years of age
- •2)Adequate hematological and renal function(defined as a creatinine
- •3)clearance >10 mL/min by day 10 posttransplant)
- •4)CMV Donor/Recipient serostatus D+/R+, D+/Râ?? and D-/R+
排除标准
- •1.)Patients refusing consent.
- •2.)Significant gastrointestinal disease that could affect drug absorption.
- •3.)suspected CMV disease at enrolment.
- •4.)HIV, hepatitis B or hepatitis C
- •5.)use of anti-CMV therapy within 30 days prior to study
- •6.)multiple organ transplantation
- •7.)allergies or previous adverse reactions to ganciclovir or valganciclovir
- •8.)severe uncontrolled diarrhea or evidence of malabsorption
- •9.)serious psychiatric or medical disorder
- •10.)male with a pregnant partner.
- •11.)liver function tests >3 times the upper level of normal (ULN).
研究者
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