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

Phase 1

• Conditions: Prophylaxis of cytomegalovirus infection in seropositive kidney transplant recipients.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-005708-13-ES
• Lead Sponsor: Fundación para la Investigación Biomedica del Hospital 12 de Octubre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-16
• Last Update Posted: 18 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

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