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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

Tracking Information
First Submitted Date  ICMJE May 7, 2015
First Posted Date  ICMJE May 12, 2015
Last Update Posted Date March 8, 2017
Study Start Date  ICMJE September 2015
Actual Primary Completion Date May 15, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02439957 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
Proportion of subjects with eGFR ≤ 45 mL/min at Wk 24 as calculated by the CKD-EPI [ Time Frame: 24 Weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE Not Provided
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Compare Efficacy of BCV to vGCV for Prevention of CMV Disease in Kidney Transplant Recipients Who Are CMV Seropositive Pretransplant
Intervention  ICMJE
  • Drug: Brincidofovir
    Other Name: BCV CMX001
  • Drug: Valganciclovir
    Other Name: vGCV
Study Arms  ICMJE
  • Active Comparator: Treatment 1
    BCV plus vGCV placebo
    Intervention: Drug: Brincidofovir
  • Active Comparator: Treatment 2
    vGCV plus BCV placebo
    Intervention: Drug: Valganciclovir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: May 7, 2015)
520
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2016
Actual Primary Completion Date May 15, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02439957
Other Study ID Numbers  ICMJE CMX001-307
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chimerix
Study Sponsor  ICMJE Chimerix
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chimerix
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP