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Assessing the Risk of CMV Infection of the Renal Transplant About R + by Cellular Immunity Analyzed by the QuantiFERON ®-CMV Test.

Assessing the Risk of CMV Infection of the Renal Transplant About R + by Cellular Immunity Analyzed by the QuantiFERON ®-CMV Test.

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02064699
Acronym
QUANTIC-R+
Enrollment
75
Registered
2014-02-17
Start date
2013-05-31
Completion date
2017-12-13
Last updated
2025-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunized Against the Cytomegalovirus, Renal Transplant Recipient

Keywords

Renal transplant, CMV, Test QuantiFERON-CMV

Brief summary

Cytomegalovirus (CMV) infection was observed in over 30% of organ recipients with high morbidity. Moreover, no prophylaxis, 75% R + D-transplanted, 55%, R + D + and D-25% R + develop CMV. The number of available antiviral drugs is reduced and noticeable side effects (neutropenia, renal toxicity) lead to premature discontinuation of therapy or the use of reduced doses that promote non-response to treatment and the emergence of resistance. In case of neutropenia, there are more an increased risk of secondary rejection due to the reduction of immunosuppressive treatment rendered necessary by the haematological reached. Rational use of these molecules is necessary with essential today as the optimal duration of prophylaxis primary issues and the prophylaxis of recurrences in case of CMV infection reported in.

Detailed description

QuantiFERON-CMV ® is a fast and standardized test that evaluates the CMV specific cellular immunity measuring the amount of secreted Interferon gamma (IFN gamma) in plasma by ELISA. It uses more epitopes of proteins including CMV glycoprotein B (gB), protein IE-1 and protein pp65 and protein pp50, which are specific for (human leukocyte antigen) HLA class I. Pretreatment of the sample is simple and plasma can be stored, frozen, for a delayed dose of interferon.

Interventions

BIOLOGICALCMV Infection

Routine follow-up (viral load, creatininaemia, neutrophil count, isolation of CMV strains when possible) and biological sample collection for. Using the QuantiFERON-CMV test for predicting the risk of CMV infection in the transplanted immune against CMV.

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Renal transplant recipient * Immunized against the Cytomegalovirus

Exclusion criteria

* Not willing to participate, no health insurance * clinical evidence of active viral infection * renal transplant recipient whose treatment includes induction antilymphocyte antibodies

Design outcomes

Primary

MeasureTime frameDescription
Predictive values of Cytomegalovirus infection1 weekCMV infection defined by a positive ADNémie confirmed on a second sample ideally one week apart.

Secondary

MeasureTime frameDescription
No response to treatment21 daysPersistence of an active CMV infection defined by a persistent ADNémie for more than 21 days under antiviral treatment.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026