Prophylactic treatment with Valganciclovir in kidney transplant CMV-seropositve patients.
Phase 1
- Conditions
- Kidney transplant cytomegalovirus-seropositiveTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2015-004406-42-ES
- Lead Sponsor
- FIBICO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
CMV-seropositive kidney transplant,
CD8 + T cell immunity specific pretransplant CMV (CMV-reactive
Quantiferon pretraspante)
> 18 years (adult)
Receiving induction therapy with Thymoglobulin
Receiving prophylaxis with valganciclovir.
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 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
Multivisceral transplants including kidney-pancreas
HIV-infected patients
Patients who can not comply with the monitoring protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method