Prophylactic treatment with Valganciclovir in kidney transplant CMV-seropositve patients.

CLINICAL TRIAL TO ASSEES THE NON-INFERIORITY OF THE SUSPENSION OF PROPHYLACTIC TREATMENT WITH VALGANCICLOVIR IN KIDNEY TRANSPLANT CMV-seropositive PATIENTS, WHO MANTEIN CD8+ CMV- CELLULAR IMMUNITY AFTER THYMOGLOBULIN TREATMENT.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004406-42-ES

Enrollment

150

Registered

2015-11-25

Start date

2016-03-10

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney transplant cytomegalovirus-seropositive

Interventions

Trade Name: VALCYTE 450 mg comprimidos recubiertos con película Pharmaceutical Form: Tablet INN or Proposed INN: VALGANCICLOVIR HYDROCHLORIDE CAS Number

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Multivisceral transplants including kidney-pancreas HIV-infected patients Patients who can not comply with the monitoring protocol

Design outcomes

Primary

Measure	Time frame
Main Objective: Meet the efficacy and safety of valganciclovir prophylaxis suspend in CMV-seropositive kidney transplant recipients with CD8 + cellular immunity CMV-specific transplant, receiving Thymoglobulin induction and maintaining cellular immunity CMV-specific CD8 + after transplantation. ; Secondary Objective: Percentage of patients developing T cell immunity in CMV-specific transplantation after receiving timoglubulina induction and valganciclovir prophylaxis. T cell development inmnunidad CD8 + CMVspecific is defined as production of ?> 0.2 interferon by CD8 + T cells stimulated by CMV-specific CMV antigens (QF reagent). ; Primary end point(s): Incidence of CMV disease at 12 months after transplantation. Study the predictive value of the assay of CD8 + T cell immunity specific for defined CMV-patients in which they can stop prophylaxis. The definition of CMV disease was based on those recommended by the American Society of Trasnplantation for use in clinical trials (Humar A. Am J Transplant 2006; 6:262-74) criteria. ;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: Meet the efficacy and safety of valganciclovir prophylaxis suspend in CMV-seropositive kidney transplant recipients with CD8 + cellular immunity CMV-specific transplant, receiving Thymoglobulin induction and maintaining cellular immunity CMV-specific CD8 + after transplantation. ; Secondary Objective: Percentage of patients developing T cell immunity in CMV-specific transplantation after receiving timoglubulina induction and valganciclovir prophylaxis. T cell development inmnunidad CD8 + CMVspecific is defined as production of ?> 0.2 interferon by CD8 + T cells stimulated by CMV-specific CMV antigens (QF reagent). ; Primary end point(s): Incidence of CMV disease at 12 months after transplantation. Study the predictive value of the assay of CD8 + T cell immunity specific for defined CMV-patients in which they can stop prophylaxis. The definition of CMV disease was based on those recommended by the American Society of Trasnplantation for use in clinical trials (Humar A. Am J Transplant 2006; 6:262-74) criteria. ;Timepoint(s) of evaluation of this end point: 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): Percentage of patients developing T cell immunity in CMV-specific transplantation after receiving timoglubulina induction and valganciclovir prophylaxis. T cell development inmnunidad CD8 + CMVspecific defined as production of ?> 0.2 interferon by CD8 + T cells stimulated by CMV-specific CMV antigens ;Timepoint(s) of evaluation of this end point: 12 months	—

Countries

Spain

Contacts

Public ContactBLANCA QUIJANO RUIZ

FIBICO

blanca.quijano@imibic.org

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026