NCT03916497

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2019

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

April 30, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

September 4, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

March 18, 2019

Last Update Submit

September 3, 2020

Conditions

Quantiferon-CMVCytomegalovirus InfectionsKidney Transplant InfectionHemodialysis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Quantification of patient cellular immunity.

    Single measurement at Day 0 of patient inclusion

  • Evaluation of kidney transplant recipient exposure to immunosuppressive therapy.

    Single collection at Day 0 of patient inclusion

  • Estimation of renal function.

    Single measurement at Day 0 of patient inclusion

  • Assessment of CMV donor humoral immunity in kidney transplant recipients.

    Single collection at Day 0 of patient inclusion

Study Arms (3)

Group 1 : kidney transplant recipients (KTR)

Diagnostic Test: Quantiferon CMV

Group 2 : hemodialysis patients

Diagnostic Test: Quantiferon CMV

Group 3 : Control patients

Diagnostic Test: Quantiferon CMV

Interventions

Quantiferon CMVDIAGNOSTIC_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

Group 1 : kidney transplant recipients (KTR)Group 2 : hemodialysis patientsGroup 3 : Control patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • For all patients :
  • to be seropositive for CMV
  • to not be opposed to the study
  • For kidney transplant recipients :
  • to have received a kidney graft for over 1 year
  • to have received an induction therapy at transplantation time by anti-lymphocytes antibodies and steroids
  • to be currently receiving immunosuppressive therapy by calcineurins inhibitors (tacrolimus or cyclosporine), mycophenolic acid with or without steroids
  • to not suffer from another cause of immunosuppression
  • For hemodialysis patients :
  • to be treated by hemodialysis for end stage renal disease
  • without prior solid organ transplant history
  • to not suffer from another cause of immunosuppression
  • For control patients :
  • with normal kidney function (estimated GFR \> 90 ml/min)
  • to not suffer from another cause of immunosuppression

You may not qualify if:

  • patient under guardianship or deprived of his liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Grenoble Alpes

Grenoble, 38043, France

Location

Related Publications (6)

  • 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.

    PMID: 15636618BACKGROUND

  • 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.

    PMID: 22179399BACKGROUND

  • 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.

    PMID: 19422346BACKGROUND

  • 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.

    PMID: 23196955BACKGROUND

  • 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.

    PMID: 23311355BACKGROUND

  • 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.

    PMID: 17462006BACKGROUND

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Lionel Rostaing

    Centre Hospitalier Universitaire Grenoble-Alpes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2019

First Posted

April 16, 2019

Study Start

April 30, 2019

Primary Completion

July 30, 2019

Study Completion

July 30, 2019

Last Updated

September 4, 2020

Record last verified: 2020-09

Locations

FR(1)