Multicenter clinical trial comparing the efficacy and safety of two strategies in the prevention of cytomegalovirus infection in kidney transplant recipients.

An open-label, randomized, parallel-group, multicenter, non-inferiority trial comparing the effectiveness and safety of an immuno-guided strategy versus a viremia-guided strategy for the prevention of cytomegalovirus infection in seropositive kidney transplant recipients.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005708-13-ES

Enrollment

Unknown

Registered

2013-05-16

Start date

2013-07-17

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Prophylaxis of cytomegalovirus infection in seropositive kidney transplant recipients.

Interventions

Trade Name: Valcyte 450 mg comprimidos recubiertos con película Product Name: Valcyte 450 mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: VALGANCICLOVIR HYDROCHLORIDE CAS Number: 17586

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Participant is aged 18 years or older. -Participant is willing and able to give informed consent (IC) for participation in the study. -Presence of end-stage renal disease (ESRD) of any cause undergoing KT regardless of donor type (live, heart-beating or non-heart-beating). - Recipient of intermediate risk, ie, seropositive for CMV (R +) (presence of a positive serology for CMV in the pre-transplant evaluation (performed at least 6 months prior to inclusion in the study) and not subject to any depletor treatment of lymphocytes. 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 354 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 354

Exclusion criteria

Exclusion criteria: The participant may not enter the study if ANY of the following apply: - Inability or unwillingness of individual or legal guardian/representative to give written IC for participation in the study. - Formal contraindication for receiving antiviral drugs (ganciclovir or valganciclovir): pregnancy or use of unreliable birth control methods; breastfeeding; preexisting or sustained neutropenia (<0.50 x 109 cells/L); creatinine clearance (CrCl) <10 mL/min; or known hypersensitivity to GCV, VGCV or aciclovir. - Participant undergoing a simultaneous double SOT (pancreas-kidney or liver-kidney). - Participant who has underwent a previous SOT or allo-HSCT. - Administration of induction therapy after transplantation with lymphocyte-depleting drugs (ATG or anti-CD3 monoclonal antibodies [muromonab]). - Infection by the human immunodeficiency virus (HIV), as assessed by serologic testing in the pre-transplant evaluation (performed at least within 6 months prior to study entry). - Participation in another clinical drug trial.

Design outcomes

Primary

Measure	Time frame
Main Objective: Demonstrate non-inferiority in terms of efficacy and safety (incidence of CMV disease over the first 6 months post-transplant) of a new strategy for prophylaxis against CMV inmunoguiada (based on systematic monitoring BMI) compared with the usual strategy of viremia guided prophylaxis (based on the early detection of viral replication and early treatment administration) in TR receivers intermediate risk (i.e. CMV seropositive at the time of transplantation (R) who have not received treatment depletor lymphocyte (ATG or muromonab)).;Secondary Objective: a) To compare the reliability and accuracy of different strategies of monitoring of the CMI response against CMV in the context of a strategy of immuno-guided prophylaxis in intermediate-risk KT recipients. b) demonstrate the decrease in the number of episodes of asymptomatic CMV viremia and the total duration of the period of viral replication "permissive" (ie, low level and without direct clinical impact). c) To demonstrate a decrease in the incidence of indirect effects attributable to CMV infection. d) To demonstrate a decrease in the number of prescriptions and the duration of antiviral drugs use and the number of hospitalization episodes in those KT recipients undergoing a strategy of immunoguided prophylaxis against CMV, as compared to those undergoing a conventional strategy of viremia-guided prophylaxis. e) To demonstrate a decrease in the incidence of adverse effects associated to such treatment in those KT recipients.;Primary end point(s): Incidence of CMV disease (defined according to the criteria proposed by Ljungman et al) during the first 6 months post-transplant [number of episodes of CMV disease per 100 recipients and per 1,000 transplant-days].;Timepoint(s) of evaluation of this end point: At 6 months	—

Measure

Time frame

Main Objective: Demonstrate non-inferiority in terms of efficacy and safety (incidence of CMV disease over the first 6 months post-transplant) of a new strategy for prophylaxis against CMV inmunoguiada (based on systematic monitoring BMI) compared with the usual strategy of viremia guided prophylaxis (based on the early detection of viral replication and early treatment administration) in TR receivers intermediate risk (i.e. CMV seropositive at the time of transplantation (R) who have not received treatment depletor lymphocyte (ATG or muromonab)).;Secondary Objective: a) To compare the reliability and accuracy of different strategies of monitoring of the CMI response against CMV in the context of a strategy of immuno-guided prophylaxis in intermediate-risk KT recipients. b) demonstrate the decrease in the number of episodes of asymptomatic CMV viremia and the total duration of the period of viral replication "permissive" (ie, low level and without direct clinical impact). c) To demonstrate a decrease in the incidence of indirect effects attributable to CMV infection. d) To demonstrate a decrease in the number of prescriptions and the duration of antiviral drugs use and the number of hospitalization episodes in those KT recipients undergoing a strategy of immunoguided prophylaxis against CMV, as compared to those undergoing a conventional strategy of viremia-guided prophylaxis. e) To demonstrate a decrease in the incidence of adverse effects associated to such treatment in those KT recipients.;Primary end point(s): Incidence of CMV disease (defined according to the criteria proposed by Ljungman et al) during the first 6 months post-transplant [number of episodes of CMV disease per 100 recipients and per 1,000 transplant-days].;Timepoint(s) of evaluation of this end point: At 6 months

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Secondary

Measure	Time frame
Secondary end point(s): -Incidence of CMV viremia during the first 6 months post-transplant [number of episodes of CMV viremia per 100 recipients and per 1,000 transplant-days]. -Incidence of other non-CMV opportunistic infections during the first 6 months post-transplant [number of episodes of opportunistic infection per 100 recipients and per 1,000 transplant-days]. -Incidence of acute rejection during the first 6 months post-transplant [number of episodes of acute rejection per 100 recipients and per 1,000 transplant-days]. -Number of prescriptions of antiviral drugs (either GCV or VGCV) and total duration of antiviral treatment during the first 6 months post-transplant [number of defined daily doses (DDD) per 1,000 transplant-days]. -Incidence of adverse events attributable to the antiviral therapy: new-onset leukopenia, neutropenia, or thrombocytopenia in the course of ganciclovir or valganclovir administration, with no alternative diagnosis during the first 6 months post-transplant [number of events per 100 recipients and per 1,000 transplant-days]. -Requirements for any cause hospitalization, hospitalization due to CMV-related clinic event, and hospitalization for administration to administer antiviral treatment during the first 6 months post-transplant [number of hospitalization days per 100 recipients].;Timepoint(s) of evaluation of this end point: At 6 months	—

Measure

Time frame

Secondary end point(s): -Incidence of CMV viremia during the first 6 months post-transplant [number of episodes of CMV viremia per 100 recipients and per 1,000 transplant-days]. -Incidence of other non-CMV opportunistic infections during the first 6 months post-transplant [number of episodes of opportunistic infection per 100 recipients and per 1,000 transplant-days]. -Incidence of acute rejection during the first 6 months post-transplant [number of episodes of acute rejection per 100 recipients and per 1,000 transplant-days]. -Number of prescriptions of antiviral drugs (either GCV or VGCV) and total duration of antiviral treatment during the first 6 months post-transplant [number of defined daily doses (DDD) per 1,000 transplant-days]. -Incidence of adverse events attributable to the antiviral therapy: new-onset leukopenia, neutropenia, or thrombocytopenia in the course of ganciclovir or valganclovir administration, with no alternative diagnosis during the first 6 months post-transplant [number of events per 100 recipients and per 1,000 transplant-days]. -Requirements for any cause hospitalization, hospitalization due to CMV-related clinic event, and hospitalization for administration to administer antiviral treatment during the first 6 months post-transplant [number of hospitalization days per 100 recipients].;Timepoint(s) of evaluation of this end point: At 6 months

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Countries

Spain

Contacts

Public ContactUnidad Investigación Clínica y EECC

Fundación para la Investigación Biomedica del Hospital 12 de Octubre

ensayosclinicos.uic@h12o.es3491779 26 35

Outcome results

None listed

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