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

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

Sponsors

Lead Sponsor: Chimerix

Source 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

Overall Status Terminated
Start Date September 2015
Completion Date January 30, 2016
Primary Completion Date January 30, 2016
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
The incidence of CMV disease, which includes CMV tissue-invasive disease and CMV syndrome, occurring anytime between randomization and week 52 52 weeks
Secondary Outcome
Measure Time Frame
Proportion of subjects with estimated glomerular filtration rate (eGFR) </=45 mL/min at wk 52 as calculated by the CKD-EPI 52 weeks
Enrollment 5
Condition
Intervention

Intervention Type: Drug

Intervention Name: Brincidofovir

Arm Group Label: Treatment 1

Other Name: CMX001

Intervention Type: Drug

Intervention Name: Valganciclovir

Arm Group Label: Treatment 2

Other Name: vGCV

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility:
St. Vincent Medical Center | Los Angeles, California, 90057, United States
University of Colorado Hospital/Health Science Center | Aurora, Colorado, 80045, United States
Yale New Haven Hospital | New Haven, Connecticut, 06520, United States
Location Countries

United States

Verification Date

July 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Treatment 1

Type: Active Comparator

Description: BCV plus vGCV placebo

Label: Treatment 2

Type: Active Comparator

Description: vGCV plus BCV placebo

Acronym BCV CMV vGCV
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov