SURPASS: A Randomized, Double-Blind, Multicenter Study of the Efficacy, Safety, and Tolerability of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus (CMV) Disease in CMV Seropositive Kidney Transplant Recipients (BCV CMV vGCV)

Description

• To compare the efficacy of brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of CMV disease in kidney transplant recipients who are CMV seropositive pretransplant and received antilymphocyte induction therapy

Study Start Date

September 2015

Estimated Completion Date

February 2017

Interventions

  • Drug: Valganciclovir
  • Drug: Brincidofovir

Specialties

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

MeSH Terms

  • Anti-Infective Agents
  • Pharmacologic Actions
  • Valganciclovir

Study ID

Chimerix -- CMX001-307

Status

Unknown

Trial ID

NCT02439957

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

520

Sponsor

Chimerix

Inclusion Criteria

  • CMV seropositive (R+), who received antilymphocyte induction therapy with antithymocyte globulin (ATG)
  • First or second kidney transplant recipient
  • 14 days posttransplant eGFR > 10mL/min by the C-G equation
  • Able to ingest tablets

Exclusion Criteria

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

Gender

Both

Ages

18 Years to 80 Years

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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