Kidney Transplant InfectionPhase 2SPARCKLINGNCT03339661
Secondary Prophylaxis After CMV Disease in Kidney Transplant Patients Targeted by γδ T Cells Immunomonitoring.
A Phase 2 study testing Group 1_No proph treatment, Group 2A_Proph treatment and γδ T cell expansion and Group 2B_Proph treatment and no γδ T cell expansion in people with Kidney Transplant Infection, run by University Hospital, Bordeaux at 2 sites in France.
Trial summary
In kidney transplant patients, CMV infection remains the leading infectious cause of morbidity and mortality. Clinical and virological relapses are common and are involved in chronic graft dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Infection
- What is being tested?
- Group 1_No proph treatment, Group 2A_Proph treatment and γδ T cell expansion and Group 2B_Proph treatment and no γδ T cell expansion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Nov 2017to 23 Nov 2020
- Phase
- Phase 2
- 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
Who may be able to join
- Male or female over 18 years old without weight or ethnicity criteria, kidney transplant.
- Patient affiliated or beneficiary of a social security scheme.
- Patient with symptomatic or non-symptomatic CMV infection requiring curative treatment with ganciclovir or valganciclovir.
- Free, informed and written consent signed by the participant and the investigator (at the latest, on the day of inclusion and before any examination required by the research).
Who cannot join
- Resistance documented to antivirals.
- Hemodialysis patient.
- Number of polymorphonuclear neutrophils less than 500 / μL and / or number of platelets less than 25,000 / μL, and / or lower hemoglobin 8 g / dL.
- Contraindication to valganciclovir, including known hypersensitivity to valganciclovir and / or aciclovir and / or valaciclovir or ganciclovir or their excipients, known severe intolerance to valganciclovir or ganciclovir.
- Women of childbearing age without a negative pregnancy test at baseline and without effective contraception (estrogen-progestin, intrauterine device) throughout the study period and two months after cessation of the follow-up period.
- Nursing women.
Show all 10Show fewer
- Men without mechanical contraception during treatment and for at least 90 days after treatment.
- Ongoing participation in another clinical trial evaluating a drug. Participation in an observational study will not be considered a contraindication.
- The patient's foreseeable inability to comply with planned visits in the protocol.
- Non-negativation of CMV PCR at 8 weeks
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Pellegrin - CHU de Bordeaux
Bordeaux, 33000
Hôpital Edouard Herriot - Hospices Civils de Lyon
Lyon, 69003
About this study
Official title: Secondary Prophylaxis After CMV Disease in Kidney Transplant Patients Targeted by γδ T
In kidney transplant patients, CMV infection remains the leading infectious cause of morbidity and mortality. Clinical and virological relapses are common and are involved in chronic graft dysfunction. To date, it is not certain that secondary prophylaxis allows reducing these relapses, although this prophylaxis is part of the current recommendations. Our team has recently shown that the expansion of γδ T cells in peripheral blood during CMV infection was correlated with the absence of virological and clinical relapses. Indeed, the absence of relapse was associated in 94.7% of cases with the presence of γδ T cells expansion while relapses occurred in about 90% of cases in the absence of γδ T cells expansion. These results suggest that the indication and duration of secondary prophylaxis after the curative treatment of CMV infection in kidney transplantation could be guided by the immune surveillance of γδ T cells.
Read the detailed description
The study aim to demonstrate that the expansion of γδ T cells at the end of curative treatment predicts the absence of virological and clinical relapses. This is a pilot study that will be conducted in the transplant center of Bordeaux and Lyon. After the curative treatment of CMV infection until a negative CMV ADNemia, secondary prophylaxis with valganciclovir will be established based on the results of γδ T cells immunomonitoring:
(I) Secondary prophylaxis will not be started in patients with γδ T cell expansion at the end of curative treatment (group 1) (II) Secondary prophylaxis will be initiated in patients who have not γδ T cell expansion and will continue for 3 months maximum. The occurrence of γδ T cells expansion during or at the end of secondary prophylaxis will define the group 2A. Patients who still not had γδ T cells expansion during or at the end of secondary prophylaxis will compose the group 2B.
The primary outcome of this study will be to evaluate the occurrence of virological relapse, assessed by monitoring CMV ADNemia, at one year of a first CMV disease, in kidney transplant patients, with secondary prophylaxis based on the monitoring of γδ T cells.
- Conditions
- Kidney Transplant Infection
- Being tested
- Group 1_No proph treatment, Group 2A_Proph treatment and γδ T cell expansion, Group 2B_Proph treatment and no γδ T cell expansion
- Keywords
- CMV infection, kidney transplant, γδ T cells monitoring
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1_No proph treatmentDrug
After the curative treatment of CMV infection until a negative CMV ADNemia, secondary prophylaxis with valganciclovir will be established based on the results of γδ T cells immunomonitoring. In this group, expansion of γδ T cell at the end curative treatment was detected, so secondary prophylaxis will not be started.
Group 2A_Proph treatment and γδ T cell expansionDrug
After the curative treatment of CMV infection until a negative CMV ADNemia, secondary prophylaxis with valganciclovir will be established based on the results of γδ T cells immunomonitoring. In this group, γδ T cell expansion will not be detected, so secondary prophylaxis will be initiated in continue during 3 months maximum. The occurrence of γδ T cells expansion during or at the end of secondary prophylaxis will define the group 2A.
Group 2B_Proph treatment and no γδ T cell expansionDrug
After the curative treatment of CMV infection until a negative CMV ADNemia, secondary prophylaxis with valganciclovir will be established based on the results of γδ T cells immunomonitoring. In this group, γδ T cell expansion will not be detected, so secondary prophylaxis will be initiated in continue during 3 months maximum. Patients who still not had γδ T cells expansion during or at the end of secondary prophylaxis will compose the group 2B.
| Study group | Role | What they receive |
|---|---|---|
| Group 1_ No proph treatment | Experimental | Patients will receive a curative treatment (ganciclovir or valganciclovir, drug administrated will depend on medical opinion) during 2 to 8 weeks. When CMV QNAT becomes regative, if γδ T cell expansion occurs, no secondary prophylaxis treatment will be introduce, and curative treatment stops. Receives: Drug: Group 1_No proph treatment |
| Group 2A_Proph treatment and γδ T cells expansion | Experimental | Patients will receive a curative treatment (ganciclovir or valganciclovir, drug administrated depends on medical opinion) during 2 to 8 weeks. When CMV QNAT becomes regative, if no γδ T cell expansion will occur, a secondary prophylaxis will be initiated during 3 months maximum. The occurrence of γδ T cells expansion during or at the end of secondary prophylaxis will define the group 2A. Receives: Drug: Group 2A_Proph treatment and γδ T cell expansion |
| Group 2B_Proph treatment and no γδ T cells expansion | Experimental | Patients will receive a curative treatment (ganciclovir or valganciclovir, drug administrated depends on medical opinion) during 2 to 8 weeks. When CMV QNAT becomes regative, if no γδ T cell expansion will occur, a secondary prophylaxis will be initiated during 3 months maximum. Patients who still not had γδ T cells expansion during or at the end of secondary prophylaxis will compose the group 2B. Receives: Drug: Group 2B_Proph treatment and no γδ T cell expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of virological relapse occurence
The primary outcome of this study will be to evaluate the occurrence of virological relapse, assessed by monitoring CMV ADNemia.
Measured: 12 months after inclusion visit
Secondary outcomes (9)
Cumulative incidence of clinical recurrence
Cumulative incidence of clinical recurrence defined by a positive CMV PCR associated with clinical and biological signs of CMV disease. This incidence is expressed as a percentage of the total number of patients with CMV infection included.
Measured: 12 months after inclusion visit
γδ T cells expansion dynamic
Description of the dynamics of γδ T cells expansion in all patients. At each visit, an immunophenotyping with analysis of the percentage of γδ T cells will be performed.
Measured: 12 months after the inclusion visit
Cumulative incidence of clinical recurrence at discontinuation of prophylaxis.
These incidences will be expressed as a percentage of the total number of patients who have had CMV infection included. Recidivism will be collected by the investigating physician when observed during a follow-up visit.
Measured: 12 months after the inclusion visit
Cumulative incidence of virological recurrence at discontinuation of prophylaxis.
These incidences will be expressed as a percentage of the total number of patients who have had CMV infection included. Recidivism will be collected by the investigating physician when observed during a follow-up visit.
Measured: 12 months after inclusion visit
secondary prophylaxis duration
The duration of the secondary prophylaxis is defined by the duration of treatment since the stop of the curative treatment until the stop of the prophylactic treatment.
Measured: 12 months after inclusion visit
Prophylaxis treatment savings evaluation
Evaluation of prophylaxis treatment savings (compared to a one-month prophylaxis) by number of subject and average total duration (with standard deviation) of treatment.
Measured: 12 months after inclusion visit
Proportion of antiviral resistant infections
the proportion of antiviral resistant infections confirmed by genotypic analysis (mutations UL97 and UL54) sought during recurrence in case of clinical suspicion.
Measured: 12 months after inclusion visit
GFR average
GFR average and its standard deviation are estimated according to MDRD formula
Measured: 12 months after inclusion visit
Compliance rate
The compliance rate will, be performed by a patient notebook.
Measured: 12 months after inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start23 Nov 2017
- Primary completion23 Nov 2020
- Study completion23 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edouard LHOMME, Dr, Study chair, USMR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339661
- Sponsor's protocol ID
- CHUBX 2016/40
- Other IDs
- 2017-002912-15, 2017
- Acronym
- SPARCKLING
- Status last verified
- Jun 2021
- First submitted
- 3 Nov 2017
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Prophylaxis After CMV Disease in Kidney Transplant Patients Targeted by γδ T
- ClinicalTrials.gov ID
- NCT03339661
- Acronym / sponsor ID
- SPARCKLING / CHUBX 2016/40
- Conditions
- Kidney Transplant Infection
- Keywords
- CMV infection, kidney transplant, γδ T cells monitoring
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 13 Nov 2017 (actual)
- 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.
In kidney transplant patients, CMV infection remains the leading infectious cause of morbidity and mortality. Clinical and virological relapses are common and are involved in chronic graft dysfunction. To date, it is not certain that secondary prophylaxis allows reducing these relapses, although this prophylaxis is part of the current recommendations. Our team has recently shown that the expansion of γδ T cells in peripheral blood during CMV infection was correlated with the absence of virological and clinical relapses. Indeed, the absence of relapse was associated in 94.7% of cases with the presence of γδ T cells expansion while relapses occurred in about 90% of cases in the absence of γδ T cells expansion. These results suggest that the indication and duration of secondary prophylaxis after the curative treatment of CMV infection in kidney transplantation could be guided by the immune surveillance of γδ T cells.
Detailed description
The study aim to demonstrate that the expansion of γδ T cells at the end of curative treatment predicts the absence of virological and clinical relapses. This is a pilot study that will be conducted in the transplant center of Bordeaux and Lyon. After the curative treatment of CMV infection until a negative CMV ADNemia, secondary prophylaxis with valganciclovir will be established based on the results of γδ T cells immunomonitoring:
(I) Secondary prophylaxis will not be started in patients with γδ T cell expansion at the end of curative treatment (group 1) (II) Secondary prophylaxis will be initiated in patients who have not γδ T cell expansion and will continue for 3 months maximum. The occurrence of γδ T cells expansion during or at the end of secondary prophylaxis will define the group 2A. Patients who still not had γδ T cells expansion during or at the end of secondary prophylaxis will compose the group 2B.
The primary outcome of this study will be to evaluate the occurrence of virological relapse, assessed by monitoring CMV ADNemia, at one year of a first CMV disease, in kidney transplant patients, with secondary prophylaxis based on the monitoring of γδ T cells.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1_ No proph treatment | Experimental | Drug: Group 1_No proph treatmentPatients will receive a curative treatment (ganciclovir or valganciclovir, drug administrated will depend on medical opinion) during 2 to 8 weeks. When CMV QNAT becomes regative, if γδ T cell expansion occurs, no secondary prophylaxis treatment will be introduce, and curative treatment stops. |
| Group 2A_Proph treatment and γδ T cells expansion | Experimental | Drug: Group 2A_Proph treatment and γδ T cell expansionPatients will receive a curative treatment (ganciclovir or valganciclovir, drug administrated depends on medical opinion) during 2 to 8 weeks. When CMV QNAT becomes regative, if no γδ T cell expansion will occur, a secondary prophylaxis will be initiated during 3 months maximum. The occurrence of γδ T cells expansion during or at the end of secondary prophylaxis will define the group 2A. |
| Group 2B_Proph treatment and no γδ T cells expansion | Experimental | Drug: Group 2B_Proph treatment and no γδ T cell expansionPatients will receive a curative treatment (ganciclovir or valganciclovir, drug administrated depends on medical opinion) during 2 to 8 weeks. When CMV QNAT becomes regative, if no γδ T cell expansion will occur, a secondary prophylaxis will be initiated during 3 months maximum. Patients who still not had γδ T cells expansion during or at the end of secondary prophylaxis will compose the group 2B. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female over 18 years old without weight or ethnicity criteria, kidney transplant.
- Patient affiliated or beneficiary of a social security scheme.
- Patient with symptomatic or non-symptomatic CMV infection requiring curative treatment with ganciclovir or valganciclovir.
- Free, informed and written consent signed by the participant and the investigator (at the latest, on the day of inclusion and before any examination required by the research).
Key exclusion criteria (10 listed)
- Resistance documented to antivirals.
- Hemodialysis patient.
- Number of polymorphonuclear neutrophils less than 500 / μL and / or number of platelets less than 25,000 / μL, and / or lower hemoglobin 8 g / dL.
- Contraindication to valganciclovir, including known hypersensitivity to valganciclovir and / or aciclovir and / or valaciclovir or ganciclovir or their excipients, known severe intolerance to valganciclovir or ganciclovir.
- Women of childbearing age without a negative pregnancy test at baseline and without effective contraception (estrogen-progestin, intrauterine device) throughout the study period and two months after cessation of the follow-up period.
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 |
|---|---|---|
| Group 1_No proph treatmentAfter the curative treatment of CMV infection until a negative CMV ADNemia, secondary prophylaxis with valganciclovir will be established based on the results of γδ T cells immunomonitoring. In this group, expansion of γδ T cell at the end curative treatment was detected, so secondary prophylaxis will not be started. | Drug | Group 1_ No proph treatment |
| Group 2A_Proph treatment and γδ T cell expansionAfter the curative treatment of CMV infection until a negative CMV ADNemia, secondary prophylaxis with valganciclovir will be established based on the results of γδ T cells immunomonitoring. In this group, γδ T cell expansion will not be detected, so secondary prophylaxis will be initiated in continue during 3 months maximum. The occurrence of γδ T cells expansion during or at the end of secondary prophylaxis will define the group 2A. | Drug | Group 2A_Proph treatment and γδ T cells expansion |
| Group 2B_Proph treatment and no γδ T cell expansionAfter the curative treatment of CMV infection until a negative CMV ADNemia, secondary prophylaxis with valganciclovir will be established based on the results of γδ T cells immunomonitoring. In this group, γδ T cell expansion will not be detected, so secondary prophylaxis will be initiated in continue during 3 months maximum. Patients who still not had γδ T cells expansion during or at the end of secondary prophylaxis will compose the group 2B. | Drug | Group 2B_Proph treatment and no γδ T cells expansion |
Primary outcome
Assessment of virological relapse occurence
Time frame: 12 months after inclusion visit
The primary outcome of this study will be to evaluate the occurrence of virological relapse, assessed by monitoring CMV ADNemia.
9 secondary outcomes
Cumulative incidence of clinical recurrence
Time frame: 12 months after inclusion visit
γδ T cells expansion dynamic
Time frame: 12 months after the inclusion visit
Cumulative incidence of clinical recurrence at discontinuation of prophylaxis.
Time frame: 12 months after the inclusion visit
Cumulative incidence of virological recurrence at discontinuation of prophylaxis.
Time frame: 12 months after inclusion visit
secondary prophylaxis duration
Time frame: 12 months after inclusion visit
Prophylaxis treatment savings evaluation
Time frame: 12 months after inclusion visit
Proportion of antiviral resistant infections
Time frame: 12 months after inclusion visit
GFR average
Time frame: 12 months after inclusion visit
Compliance rate
Time frame: 12 months after inclusion visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
Related trials for Kidney Transplant Infection
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
RecruitingPhase 2
A Trial to Evaluate the Safety, Tolerability and Efficacy of AIC263029 in Kidney Transplant Recipients With BKV Infection
BK Virus Infection, BKV Infection
RecruitingPhase 3
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
Not yet recruitingPhase 3
Prediction and Prevention of Bloodstream Infections After Kidney Transplantation
Kidney Transplant Infection, Bloodstream Infection
RecruitingPhase 1/2
Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
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.
Edouard LHOMME, Dr study chair
USMR
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Group 1_No proph treatment, Group 2A_Proph treatment and γδ T cell expansion and Group 2B_Proph treatment and no γδ T cell expansion in people with Kidney Transplant Infection, run by University Hospital, Bordeaux at 2 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of virological relapse occurence (time frame: 12 months after inclusion visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2026.