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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A00101-56 | Other Identifier | ID RCB |
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Evaluation of anti-CMV T cellular immunity using an IGRA test (Quantiferon-CMV test) in kidney transplant recipients and hemodialysis patients, comparison to control patients.
Cytomegalovirus (CMV) infection is a common opportunistic complication after kidney transplantation (KT). It has been associated with high morbidity and mortality in kidney transplant recipients (KTR). Its actual management is only based on the humoral immunity : the main risk factor for CMV infection after KT is the association of a seropositive donor and a seronegative recipient (so-called "D+/R- mismatch").
However several studies have highlighted the essential role of cellular immunity to control CMV infection. The Quantiferon-CMV (QF-CMV) is an IGRA test (Interferon Gamma Releasing Assay) which evaluates T CD8 lymphocytes production of Interferon Gamma (IFNy) exposed to CMV antigens. Some studies have shown the possible interest of the QF-CMV in predicting CMV infection after antiviral prophylaxis discontinuation or when CMV viremia is detected.
However some limits have been underlined. First its positivity threshold hasn't been approved in KTR. Hemodialysis patients (HP) called to receive a renal allograft also suffered from altered immunity. No study has directly compared the QF-CMV value in KTR, HP and control patients.
That's why we propose evaluating the expression of basal cellular immunity against CMV (far from any active infection) in KTR and HP using the QF-CMV and comparing it to control patients population (not suffering from kidney dysfunction or immunosuppression).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 : kidney transplant recipients (KTR) |
| ||
| Group 2 : hemodialysis patients |
| ||
| Group 3 : Control patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantiferon CMV | Diagnostic Test | Evaluate and compare interferon gamma (IFNy) production by T CD8 cells exposed to CMV antigens in CMV seropositive kidney transplant recipients, hemodialysis and control patients |
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of anti-CMV T cellular immunity in kidney transplant recipients, hemodialysis patients and control patients. | Quantification of IFNy level producted by T cells exposed to CMV antigens using a Quantiferon-CMV test in kidney transplant recipients, hemodialysis patients and control patients. | Single measurement at Day 0 of patient inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of patient cellular immunity. | Quantification of lymphocytes subpopulations. | Single measurement at Day 0 of patient inclusion |
| Evaluation of kidney transplant recipient exposure to immunosuppressive therapy. |
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Inclusion Criteria :
For all patients :
For kidney transplant recipients :
For hemodialysis patients :
For control patients :
Exclusion Criteria :
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Kidney transplant recipients will be recruited among KTR followed in the Kidney transplant department of Grenoble University Hospital.
Hemodialysis patients will be recruited among hemodialysis patients on the waiting list for a kidney transplant in the Kidney transplant department of Grenoble University Hospital.
Control patients will be recruited among non-hemodialysis and non-kidney transplanted patients followed in the Grenoble University Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Lionel Rostaing | Centre Hospitalier Universitaire Grenoble-Alpes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Grenoble Alpes | Grenoble | 38043 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15636618 | Background | Radha R, Jordan S, Puliyanda D, Bunnapradist S, Petrosyan A, Amet N, Toyoda M. Cellular immune responses to cytomegalovirus in renal transplant recipients. Am J Transplant. 2005 Jan;5(1):110-7. doi: 10.1111/j.1600-6143.2003.00647.x. | |
| 22179399 | Background | Lisboa LF, Kumar D, Wilson LE, Humar A. Clinical utility of cytomegalovirus cell-mediated immunity in transplant recipients with cytomegalovirus viremia. Transplantation. 2012 Jan 27;93(2):195-200. doi: 10.1097/TP.0b013e31823c1cd4. |
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Assessment of last tacrolimus trough concentration.
| Single collection at Day 0 of patient inclusion |
| Estimation of renal function. | Evaluation of estimated glomerular filtration rate by plasmatic creatinin dosage using CKD-EPI estimate. | Single measurement at Day 0 of patient inclusion |
| Assessment of CMV donor humoral immunity in kidney transplant recipients. | Assessment of donor CMV serology. | Single collection at Day 0 of patient inclusion |
| 19422346 | Background | Kumar D, Chernenko S, Moussa G, Cobos I, Manuel O, Preiksaitis J, Venkataraman S, Humar A. Cell-mediated immunity to predict cytomegalovirus disease in high-risk solid organ transplant recipients. Am J Transplant. 2009 May;9(5):1214-22. doi: 10.1111/j.1600-6143.2009.02618.x. |
| 23196955 | Background | Manuel O, Husain S, Kumar D, Zayas C, Mawhorter S, Levi ME, Kalpoe J, Lisboa L, Ely L, Kaul DR, Schwartz BS, Morris MI, Ison MG, Yen-Lieberman B, Sebastian A, Assi M, Humar A. Assessment of cytomegalovirus-specific cell-mediated immunity for the prediction of cytomegalovirus disease in high-risk solid-organ transplant recipients: a multicenter cohort study. Clin Infect Dis. 2013 Mar;56(6):817-24. doi: 10.1093/cid/cis993. Epub 2012 Nov 29. |
| 23311355 | Background | Cantisan S, Lara R, Montejo M, Redel J, Rodriguez-Benot A, Gutierrez-Aroca J, Gonzalez-Padilla M, Bueno L, Rivero A, Solana R, Torre-Cisneros J. Pretransplant interferon-gamma secretion by CMV-specific CD8+ T cells informs the risk of CMV replication after transplantation. Am J Transplant. 2013 Mar;13(3):738-45. doi: 10.1111/ajt.12049. Epub 2013 Jan 11. |
| 17462006 | Background | Walker S, Fazou C, Crough T, Holdsworth R, Kiely P, Veale M, Bell S, Gailbraith A, McNeil K, Jones S, Khanna R. Ex vivo monitoring of human cytomegalovirus-specific CD8+ T-cell responses using QuantiFERON-CMV. Transpl Infect Dis. 2007 Jun;9(2):165-70. doi: 10.1111/j.1399-3062.2006.00199.x. |
| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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