A study to compare low dose versus recommended dose of the anti viral drug valganciclovir in preventing cytomegalovirus infection in renal transplant recipients
- Conditions
- Health Condition 1: null- immediate Post renal trasnplant recipientsHealth Condition 2: Z940- Kidney transplant status
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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+
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cytomegalovirus incidenceTimepoint: one, three and six months
- Secondary Outcome Measures
Name Time Method 1)Adverse effects, acute rejection, opportunistic infection, eGFR. <br/ ><br>2) To screen for other immunomodulatory viruses such as hepatitis B,hepatitis C and BK virus when where necessary. <br/ ><br>Timepoint: one,three and six months