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CompletedPhase 4ACTRN12610000015044

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

A randomised study comparing universal valacyclovir prophylaxis with quantitative polymerase chain reaction (PCR) based preemptive therapy for cytomegalovirus (CMV) disease in renal transplant recipients.

Sponsor

Tomas Reischig, M.D., Ph.D.

Enrollment

60 participants

Start Date

Oct 22, 2003

Study Type

Interventional

Conditions

Cytomegalovirus disease in renal transplant recipients

Summary

The aim of the study is to compare the efficacy, safety and cost of preemptive therapy with vaganciclovir (based on quantitative PCR monitoring) versus universal 3-month prophylaxis with valacyclovir (control group, current standard in our transplant centre).

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares two strategies for preventing a common viral infection called CMV in adults aged 18 and older who have received a kidney transplant. One approach treats patients only when the virus is detected, while the other gives preventive antiviral medication to all at-risk patients. People with unknown CMV status or allergies to antiviral medications cannot participate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Preemptive therapy in the case of significant positivity of PCR for CMV deoxyribonucleic acid (DNA) (>2000 copies/ml) - oral valganciclovir (Valcyte, Hoffman-La Roche, Germany) 900mg twice per day unt

Preemptive therapy in the case of significant positivity of PCR for CMV deoxyribonucleic acid (DNA) (>2000 copies/ml) - oral valganciclovir (Valcyte, Hoffman-La Roche, Germany) 900mg twice per day until clearance of CMV viremia (negative result of PCR for CMV DNA) or for a minimum of 14 days commenced during first year post-transplant.

Locations(1)

Czech Republic

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ACTRN12610000015044