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IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients

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Roche

Status and phase

Completed
Phase 3

Conditions

Cytomegalovirus Infections

Treatments

Drug: Valganciclovir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00294515
NT18435

Details and patient eligibility

About

This study will determine the relative efficacy and safety of up to 100 days Valcyte prophylaxis relative to up to 200 days Valcyte prophylaxis when given for the prevention of CMV disease in high-risk (D+/R-) kidney allograft recipients. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Enrollment

326 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ≥ 16 years of age
  • CMV seronegative recipient of primary or secondary renal allograft from a living or cadaveric seropositive donor
  • Adequate hematological and renal function
  • Patients and partners must agree to maintain effective birth control for 90 days following cessation of study medication

Exclusion criteria

  • CMV disease, or receipt of anti-CMV therapy within 30 days prior to screening
  • Multi-organ transplant recipient
  • Hepatitis B, hepatitis C or HIV positive
  • Women who are pregnant or lactating

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

326 participants in 2 patient groups

Valganciclovir up to 100 days
Experimental group
Description:
Valganciclovir for up to 100 days post kidney transplant
Treatment:
Drug: Valganciclovir
Drug: Valganciclovir
Valganciclovir up to 200 days
Active Comparator group
Description:
Valganciclovir for up to 200 days post kidney transplant
Treatment:
Drug: Valganciclovir
Drug: Valganciclovir

Trial contacts and locations

80

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Data sourced from clinicaltrials.gov

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