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Trial record 5 of 296 for:    "Cytomegalic inclusion disease"

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 (BCV CMV vGCV)

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ClinicalTrials.gov Identifier: NCT02439970
Recruitment Status : Terminated (Study was terminated early due to results from another CMX study)
First Posted : May 12, 2015
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Chimerix

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Cytomegalovirus Disease Drug: Brincidofovir Drug: Valganciclovir Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: 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 Recipient
Study Start Date : September 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018


Arm Intervention/treatment
Active Comparator: Treatment 1
BCV plus vGCV placebo
Drug: Brincidofovir
Other Name: 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 week 52 [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Proportion of subjects with estimated glomerular filtration rate (eGFR) </=45 mL/min at wk 52 as calculated by the CKD-EPI [ Time Frame: 52 weeks ]


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

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

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): NCT02439970


Locations
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

Responsible Party: Chimerix
ClinicalTrials.gov Identifier: NCT02439970     History of Changes
Other Study ID Numbers: CMX001-303
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017

Keywords provided by Chimerix:
kidney transplant allograft
recipients

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valganciclovir
Ganciclovir
Antiviral Agents
Anti-Infective Agents