CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 160 enrolled
Drug / intervention
BIOMARKER- elispot testother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02550639
NCT02550639Phase 4Completed

A Prospective Randomized Study for Predicting Human Cytomegalovirus (hCMV) Infection According to Baseline hCMV-specific T-cell Response in Kidney Transplant Patients (RESPECT)

ORIOL BESTARD·interventional·Posted Sep 15, 2015·Updated Oct 3, 2018

In Brief

A Phase 4 clinical trial evaluating BIOMARKER- elispot test for CMV Infection and Kidney Transplantation. Completed, enrolled 160 participants across 5 sites in 2 countries.

Detailed Summary

The aim of this prospective, randomized study is to assess a subject's immunological status against hCMV before kidney transplantation by an hCMV-specific interferon (INF)-γ ELISPOT technique confirming previous results and establishing their statistical validity in order to determine whether this test could be used routinely in clinical practice to assess the risk of developing hCMV infection after renal transplantation and, ultimately, identify the most effective individual antiviral therapeutic strategy against hCMV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Spain
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 15, 2015
Enrollment StartFeb 1, 2014
Primary CompletionSep 1, 2018
Study CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 10.8 years ago

Interventions

BIOMARKER- elispot testother

ELISPOT TEST