Cytomegalovirus-specific immune monitoring to guide pre-emptive therapy surveillance protocol for prevention of cytomegalovirus infection after renal transplantation.

Phase 4

Recruiting

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

• Registration Number: ACTRN12618000913279
• Lead Sponsor: associate 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: 2018-05-30
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Adult (>18 years with no upper age limit) renal transplant candidates, male or female.
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/HLA compatible or incompatible) donors with known CMV serology before transplantation. Donor CMV serology will be performed in transplant center which procures the donor.
Donor/Recipient CMV serostatus of D+/R-, D+/R+, and D-/R+. Recipient CMV serology will be regularly (every 3 months) evaluated in all wait-listed patients at the Department of Virology, Universtity Hospital in Pilsen and finally confirmed at the time of transplantation.
Ability to sign informed consent.

Exclusion Criteria

Unknown pretransplantation CMV serology of the donor or recipient.
D-/R- CMV serostatus.
Active systemic viral infection within 2 weeks before transplantation except for active hepatitis B or hepatitis C infection neccesitating antiviral therapy.
Therapy with systemic antiviral agents within 2 weeks before transplantation except for treatment of hepatitis B or C (lamivudine, adefovir, entecavir, DAAs).
White blood cell (WBC) count <3.0 x 109/L.
Platelet count <100 x 109/L.
Allergy to ganciclovir.
Inclusion to another clinical trial.
Inability to provide informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified