Renal Transplant RecipientQUANTIC-R+NCT02064699
Assessing the Risk of CMV Infection of the Renal Transplant About R + by Cellular Immunity Analyzed by the QuantiFERON ®-CMV Test.
An observational study of Renal Transplant Recipient and Immunized Against the Cytomegalovirus, run by University Hospital, Limoges at 12 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant Recipient, Immunized Against the Cytomegalovirus
- What is being tested?
- CMV Infection
- Type of treatment
- Vaccines
- How many people
- 75 participants
- Where
- 12 sitesFrance
- Study dates
- May 2013to 13 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Renal transplant recipient Immunized against the Cytomegalovirus.
Who may be able to join
- Renal transplant recipient
- Immunized against the Cytomegalovirus
Who cannot join
- Not willing to participate, no health insurance
- clinical evidence of active viral infection
- renal transplant recipient whose treatment includes induction antilymphocyte antibodies
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Virologie
Besançon, 25
Virologie
Caen, 14
Virologie
Clermont-Ferrand, 63
Virologie
Grenoble, 38
Virologie
Lille, 59
Bactériologie Virologie
Limoges, 87042
Virologie
Nantes, 44
Virologie
Reims, 51
Virologie
Rennes, 35
Virologie
Saint-Etienne, 42
Virologie
Strasbourg, 67
Foch Hospital
Suresnes, 92151
About this study
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.
Read the 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.
- Being tested
- CMV Infection
- Keywords
- Renal transplant, CMV, Test QuantiFERON-CMV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMV InfectionBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| CMV infection | Renal transplant recipient immunized against the Cytomegalovirus Receives: Biological: CMV Infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive values of Cytomegalovirus infection
CMV infection defined by a positive ADNémie confirmed on a second sample ideally one week apart.
Measured: 1 week
Secondary outcomes (1)
No response to treatment
Persistence of an active CMV infection defined by a persistent ADNémie for more than 21 days under antiviral treatment.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startMay 2013
- Primary completion13 Dec 2017
- Study completion13 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Transplant RecipientStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie ALAIN, MD, Principal investigator, Limoges UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064699
- Sponsor's protocol ID
- I10002 QUANTIC-R+
- Acronym
- QUANTIC-R+
- Status last verified
- Jul 2025
- First submitted
- 14 Feb 2014
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Mafi S, Essig M, Rerolle JP, Lagathu G, Crochette R, Brodard V, Schvartz B, Gouarin S, Bouvier N, Engelmann I, Garstka A, Bressollette-Bodin C, Cantarovitch D, Germi R, Janbon B, Archimbaut C, Heng AE, Garnier F, Gomes-Mayeras M, Labrunie A, Hantz S, Alain S. Torque teno virus viremia and QuantiFERON(R)-CMV assay in prediction of cytomegalovirus reactivation in R+ kidney transplant recipients. Front Med (Lausanne). 2023 Jun 22;10:1180769. doi: 10.3389/fmed.2023.1180769. eCollection 2023.
PubMed 37425298
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Risk of CMV Infection of the Renal Transplant About R + by Cellular Immunity Analyzed by the QuantiFERON ®-CMV Test.
- ClinicalTrials.gov ID
- NCT02064699
- Acronym / sponsor ID
- QUANTIC-R+ / I10002 QUANTIC-R+
- Keywords
- Renal transplant, CMV, Test QuantiFERON-CMV
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- 13 Dec 2017 (actual)
- Study completion
- 13 Dec 2017 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMV infection | – | Biological: CMV InfectionRenal transplant recipient immunized against the Cytomegalovirus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Renal transplant recipient Immunized against the Cytomegalovirus.
Key inclusion criteria (2 listed)
- Renal transplant recipient
- Immunized against the Cytomegalovirus
Key exclusion criteria (3 listed)
- Not willing to participate, no health insurance
- clinical evidence of active viral infection
- renal transplant recipient whose treatment includes induction antilymphocyte antibodies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMV InfectionRoutine 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. | Biological | CMV infection |
Primary outcome
Predictive values of Cytomegalovirus infection
Time frame: 1 week
CMV infection defined by a positive ADNémie confirmed on a second sample ideally one week apart.
1 secondary outcome
No response to treatment
Time frame: 21 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Results publication: PubMed 37425298Mafi S, Essig M, Rerolle JP, Lagathu G, Crochette R, Brodard V, Schvartz B, Gouarin S, Bouvier N, Engelmann I, Garstka A, Bressollette-Bodin C, Cantarovitch D, Germi R, Janbon B, Archimbaut C, Heng AE, Garnier F, Gomes-Mayeras M, Labrunie A, Hantz S, Alain S. Torque teno virus viremia and QuantiFERON(R)-CMV assay in prediction of cytomegalovirus reactivation in R+ kidney transplant recipients. Front Med (Lausanne). 2023 Jun 22;10:1180769. doi: 10.3389/fmed.2023.1180769. eCollection 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie ALAIN, MD principal investigator
Limoges UH
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Transplant Recipient and Immunized Against the Cytomegalovirus, run by University Hospital, Limoges at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive values of Cytomegalovirus infection (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02064699, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.