cytomegalovirus infection in renal tranplant recipients MedDRA version: 16.1 Level: PT Classification code 10011831 Term: Cytomegalovirus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: valcyte
Pharmaceutical Form: Coated tablet
INN or Proposed INN: VALGANCICLOVIR
CAS Number: 175865-60-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4
Sponsors
HOSPITAL UNIVERSITARI DE BELLVITGE
Eligibility
Sex/Gender
All
Inclusion criteria
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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
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 7. Other patients with no renal graft. 8. Patients with active viral replication of HCV, HBV and / or HIV 9. Treatment that is to receive maintenance immunosuppression including mTOR inhibitors. 10. Patients requiring a desensitizing treatment including plasma exchange, Campath-1, Rituximab ®, Soliris ® and / or gamma globulin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether the incidence of hCMV infection after renal transplantation in the group of patients without receiving prophylactic antiviral therapy (pre-emptive, A2 and B2 groups) will be significantly higher among those patients without hCMV-specific cellular response (memory / effector T cells against antigen hCMV IE-1) (group B2) compared to individuals with detectable hCMV-specific cellular response (group A2) using IFN-gamma ELISPOT technique;Secondary Objective: To evaluate-the incidence of late HCMV infection after Receiving prophylactic treatment for 3 months in the group of patients without T cell response memory / effector antigen against hCMV IE-1 (group B1) Compared to Individuals with positive ELISPOT (detection T cell memory / effector antigen against hCMV IE-1) (group A1). Assess the effect of type of preventive treatment in the group of patients With the same result of anti-hCMV Elispot. To Assess the Ability of spontaneous viral clearance in relation to the response of memory / hCMV-specific to each single EVALUATED by ELISPOT effector. To study the behavior in time of the response of hCMV-specific cellular memory (T) by the ELISPOT technique after transplantation under immunosuppressive therapy based on anti-regime clacineutínico Both in patients under antiviral prophylactic strategy or anticipated (Preemptive).;Primary end point(s): Incidence of hCMV infection in patients receiving preemtive therapy in both positive and negative ELISPOT groups;Timepoint(s) of evaluation of this end point: 6 MONTHS AND 12 MONTHS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Incidence of late hCMV infection in patients receiving prophylactic treatment in both positive and negative ELISPOT groups. Changes in hCMV-specific T cell immune response after transplantation and under immunosuppressant treatment by IFN-? ELISPOT technique Incidence of acute rejection episodes and its correlation with hCMV-specific ELISPOT test results performed before and after transplantation Incidence of valganciclovir-related Adverse Events;Timepoint(s) of evaluation of this end point: 6 MESES Y 12 MESES | — |
Countries
Spain
Contacts
Public ContactCAROLINA POLO
IDIBELL- INSTITUT D'INVESTIGACIÓ BIOMÈDICA DE BELLVITGE
Outcome results
None listed