A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation

Roche

Status and phase: Completed; Phase 3

Conditions: Cytomegalovirus Infections

Treatments: Drug: Ganciclovir; Drug: Valganciclovir CMV Prophylaxis; Drug: Valganciclovir (Pre-emptive CMV Therapy)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00372229

ML19313

Details and patient eligibility

About

This 2 arm study will compare the efficacy of 100 days of Valcyte (900mg po daily) prophylaxis with that of no prophylaxis, under the condition of pre-emptive therapy of active CMV infection, in CMV positive renal transplant recipients. The influence of the two prevention concepts on the occurrence of direct and indirect effects of active CMV infections will be compared. The anticipated time on study treatment is 3 months-1 year, and the target sample size is 100-500 individuals.

Enrollment: 299 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary or secondary renal allograft within preceding 14 days;
• IgG seropositive for CMV;
• receiving immunosuppressive therapy.

Exclusion criteria

• active CMV infection;
• current/history of malignancy;
• acute steroid resistant rejection episode since transplantation.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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299 participants in 2 patient groups

Valganciclovir Cytomegalovirus (CMV) Prophylaxis

Experimental group

Treatment:

Drug: Valganciclovir CMV Prophylaxis

Pre-emptive CMV Therapy

Active Comparator group

Treatment:

Drug: Valganciclovir (Pre-emptive CMV Therapy)

Drug: Ganciclovir