STUDY FOR THE DIAGNOSIS OF CYTOMEGALOVIRUS INFECTION IN RENAL TRANSPLANT PATIENTS BY THE EVALUATION OF THE IMMUNE RESPONSE BEFORE TRANSPLANTATIO

Phase 1

• Conditions: cytomegalovirus infection in renal tranplant recipients; MedDRA version: 19.0Level: PTClassification code 10011831Term: Cytomegalovirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-004445-17-BE
• Lead Sponsor: HOSPITAL UNIVERSITARI DE BELLVITGE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-10
• Last Update Posted: 16 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Subjects > 18 years old, both male and females, any race, with body weight >34 kg
2. Subjects are hCMV positive and are due to receive a hCMV seropositive donor renal allograft
3. Availability of receptor blood samples pre transplant to perform hCMV-specific ELISPOT determination.
4. Subject is willing to participate in the study and has signed the Informed Consent Form. If a patient is unable to consent by writing, a legal representative is allowed to sign in his place.
5. Women of Childbearing Potential must have a negative pregnancy test performed at the moment of inclusion and must accept the use of a reliable anticonceptive method during the lenght of the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

1. hCMV-specific ELISPOT test result indeterminate or lack of receptor blood sample to perform the test
2. Subjects with a previously known tipe I hypersensibility or documented idiosyncratic reactions to ganciclovir(GCV)/valganciclovir(VGCV).
3. Pregnant or lactating women.
5. Any clinically significant disease that in the opinion of the investigator might interfere with the procedures of the trial
6. Participation in another industry sponsored clinical trial that defines the treatment of CMV infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified