OVERT Study: Optimizing Valganciclovir Efficacy in Renal Transplantatio

Phase 4

Active, not recruiting

• Conditions: Cytomegalovirus infection after renal transplantation; Infection - Studies of infection and infectious agents; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12613000554763
• Lead Sponsor: ass. Prof. Tomas Reischig, M.D., Ph.D.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-16
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Adult renal transplant candidates, complement-dependent cytotoxicity (CDC) cross-match negative at the time of transplantation, deceased (non-heart-beating donors or dual kidney transplantation are allowed) or living (both related and unrelated, AB0 compatible or incompatible) donors with known cytomegalovirus (CMV) serology before transplantation, CMV serology: donor(D)/recipient (R) serostatus of D+/R-, D+/R+, and D-/R+, ability to sign informed consent.

Exclusion Criteria

Unknown pretransplantation CMV serology of the donor or recipient, D-/R- CMV serostatus, treatment of systemic viral infection within 2 weeks before transplantation except for active hepatitis B or hepatitis C infection, therapy with systemic antiviral agents within 2 weeks before transplantation except for treatment of hepatitis B (lamivudine, adefovir, entecavir), white blood cell (WBC) count <3.0 x 10exp9/L, platelet count <100 x 10exp9/L, allergy to ganciclovir, inclusion to another clinical trial, inability to provide informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified