SUSTAIN: A Randomized, Double-Blind, Multicenter, Phase 3 Study of the Efficacy, Safety, and Tolerability of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Disease in CMV Seronegative Kidney Allograft Recipients

Description

To compare the efficacy of brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of cytomegalovirus (CMV) disease in kidney transplant allograft recipients who are CMV seronegative pretransplant and received a kidney from a CMV seropositive donor

Study Start Date

September 2015

Estimated Completion Date

September 2018

Interventions

  • Drug: Valganciclovir
  • Drug: Brincidofovir

Specialties

  • Infectious Disease: Antimicrobials,Other Viral/Bacterial,Surgery/Burn/Transplant,Urogenital
  • Nephrology: Transplantation
  • Pharmacy: Antimicrobials

MeSH Terms

  • Cytomegalovirus Infections
  • DNA Virus Infections
  • Ganciclovir
  • Herpesviridae Infections
  • Valganciclovir
  • Virus Diseases

Study ID

Chimerix -- CMX001-303

Status

Unknown

Trial ID

NCT02439970

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

750

Sponsor

Chimerix

Inclusion Criteria

  • CMV seronegative recipient who received a kidney from a CMV seropositive donor
  • First or second kidney transplant recipient
  • Within 14 days post transplant, eGFR > 10 mL/min by the C-G equation
  • Able to ingest tablets

Exclusion Criteria

  • Multiorgan transplant recipient
  • Plasma CMV PCR >LOD by the central lab

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (3)

Study Location Distance Name Phone Email
Yale New Haven Hospital - New Haven, Connecticut 18.1 miles None None None
University of Colorado HospitalHealth Science Center - Aurora, Colorado 1,658.2 miles None None None
St Vincent Medical Center - Los Angeles, California 2,490.5 miles None None None

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