Preemptive therapy vs valacyclovir prophylaxis for cytomegalovirus (CMV) disease after renal transplantatio

Phase 4

Completed

• Conditions: Cytomegalovirus disease in renal transplant recipients; Infection - Studies of infection and infectious agents; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12610000015044
• Lead Sponsor: Tomas Reischig, M.D., Ph.D.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-06-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

adult (>18 years) renal transplant recipient, donor (D) and recipient (R) pretransplant CMV serological status: D+/R-, D+/R+, D-/R+, deceased (including non-heart-beating) or living donor, informed consent

Exclusion Criteria

unknown or D-/R- CMV serostatus pretransplant, allergy to acyclovir, valacyclovir, ganciclovir, and/or valganciclovir, active viral infection at the time of transplantation (including active hepatitis B infection), therapy with systemic antiviral agents <2 weeks prior to transplantation, white blood cell (WBC) count <3.5 x 10exp9/L, platelet count <100 x 10exp9/L, inability to sign informed consent, concomitant inclusion to another clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of CMV disease (defined by clinical symptoms + presence of CMV viremia by quantitative PCR CMV DNA test)[12 months post transplant];acute rejection (clinical + subclinical) diagnosed by renal allograft biopsy[12 months post transplant];Histologically proven interstitial fibrosis/tubular atrophy of the allograft, expression of messenger ribonucleic acid (mRNA) cytokines intragraft included[36 months post transplant]