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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) (BCV CMV vGCV)

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ClinicalTrials.gov Identifier: NCT02439957
Recruitment Status : Terminated
First Posted : May 12, 2015
Last Update Posted : March 8, 2017
Sponsor:
Information provided by (Responsible Party):
Chimerix

Brief Summary:
• 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

Condition or disease Intervention/treatment Phase
Compare Efficacy of BCV to vGCV for Prevention of CMV Disease in Kidney Transplant Recipients Who Are CMV Seropositive Pretransplant Drug: Brincidofovir Drug: Valganciclovir Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Study Start Date : September 2015
Actual Primary Completion Date : May 15, 2016
Actual Study Completion Date : July 31, 2016

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Arm Intervention/treatment
Active Comparator: Treatment 1
BCV plus vGCV placebo
Drug: Brincidofovir
Other Name: BCV CMX001

Active Comparator: Treatment 2
vGCV plus BCV placebo
Drug: Valganciclovir
Other Name: vGCV




Primary Outcome Measures :
  1. The incidence of CMV disease, which includes CMV tissue-invasive disease and CMV syndrome, occurring anytime between randomization and Wk 24 posttransplant. [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Proportion of subjects with eGFR ≤ 45 mL/min at Wk 24 as calculated by the CKD-EPI [ Time Frame: 24 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439957


Locations
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United States, California
St. Vincent Medical Center
Los Angeles, California, United States, 90057
United States, Colorado
University of Colorado Hospital/Health Science Center
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Chimerix

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Responsible Party: Chimerix
ClinicalTrials.gov Identifier: NCT02439957     History of Changes
Other Study ID Numbers: CMX001-307
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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Valganciclovir
Antiviral Agents
Anti-Infective Agents