NCT05238220

Brief Summary

The purpose of this study is to evaluate whether the use of the Viracor® CMV immunity assay at 6 months post-transplant in CMV high risk kidney transplant recipients would help identify those patients at higher risk of post-prophylaxis CMV viremia or disease and thereby select those patients in which a longer duration of valganciclovir prophylaxis would be beneficial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

1.5 years

First QC Date

February 3, 2022

Last Update Submit

November 8, 2024

Conditions

Kidney Transplant; Complications

Outcome Measures

Primary Outcomes (1)

  • Use of Viracor CMV immunity assay

    continue valganciclovir prophylaxis for additional time due to absence of demonstrated anti-CMV immunity

    6 months post-transplant through 12 months prophylaxis

Study Arms (2)

continue valganciclovir prophylaxis

continue valganciclovir prophylaxis for up to 12 months total when anti-CMV immunity absent

Drug: Valganciclovir

discontinue valganciclovir prophylaxis

discontinue valganciclovir prophylaxis when anti-CMV immunity present after routine care prophylaxis

Interventions

ValganciclovirDRUG

continuation of valganciclovir prophylaxis up to 12 months with absence of demonstrated anti-CMV immunity

continue valganciclovir prophylaxis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CMV High Risk Kidney Transplant Recipients

You may qualify if:

  • Able to provide consent
  • Kidney Transplant Recipients
  • Classified as CMV high risk at time of transplant (donor CMV IgG positive and recipient CMV IgG negative)

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Piedmont Atlanta Hospital

Atlanta, Georgia, 30309, United States

Location

MeSH Terms

Interventions

Valganciclovir

Intervention Hierarchy (Ancestors)

GanciclovirAcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Transplant Nephrologist

Study Record Dates

First Submitted

February 3, 2022

First Posted

February 14, 2022

Study Start

January 4, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)