Cytomegalovirus Risk in Seropositive Kidney Transplant Recipients Stratified by Quantiferon-CMV

NCT03858907 | Unknown

• 1 other identifier: quantiferon-cmv_ktx
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the Quantiferon-CMV test ability to predict occurrence of cytomegalovirus (CMV) disease o treated infection after kidney transplantation. Patients studied are those already infected by CMV before transplantation ("seropositive"). Patients given thymoglobulin as induction therapy receive CMV prophylaxis with valganciclovir, while those given basiliximab undergo weekly monitoring for CMV viremia with preemptive treatment as needed.

Conditions

Cytomegalovirus Infections; CMV; Kidney Transplant Infection

Outcome Measures

Primary Outcomes (1)

• CMV disease/treated infection occurrence according to Quantiferon-CMV result

  To evaluate if QF-CMV (either pre or post-transplant) predicts occurrence of CMV disease or treated infection in CMV seropositive kidney recipients, stratified by type of induction therapy

  365 days

Secondary Outcomes (7)

• QF-CMV cutoff values

  365 days

• CMV risk prediction index

  365 days

• Association of CMV with clinical events

  365 days

• Association of CMV and patient and graft survivals

  365 days

• Association of CMV and total IgG levels

  365 days

Other Outcomes (1)

• Infection and acute rejection prediction with Quantiferon-Monitor

  365 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant recipients from a big tertiary hospital in Sao Paulo, Brazil

You may qualify if:

• CMV IgG seropositivity before kidney transplant
• to provide signed Informed Consent

You may not qualify if:

• death or graft failure before day 19 post-transplant
• allergy to valganciclovir ou ganciclovir

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clinicas, University of Sao Paulo School of MedicinE

São Paulo, São Paulo, 05403-900, Brazil

RECRUITING

Related Publications (7)

• Reusing JO Jr, Feitosa EB, Agena F, Pierrotti LC, Azevedo LSF, Kotton CN, David-Neto E. Cytomegalovirus prophylaxis in seropositive renal transplant recipients receiving thymoglobulin induction therapy: Outcome and risk factors for late CMV disease. Transpl Infect Dis. 2018 Oct;20(5):e12929. doi: 10.1111/tid.12929. Epub 2018 Jul 2.

  PMID: 29809309 BACKGROUND

• Kotton CN, Kumar D, Caliendo AM, Huprikar S, Chou S, Danziger-Isakov L, Humar A; The Transplantation Society International CMV Consensus Group. The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation. Transplantation. 2018 Jun;102(6):900-931. doi: 10.1097/TP.0000000000002191.

  PMID: 29596116 BACKGROUND

• David-Neto E, Triboni AH, Paula FJ, Vilas Boas LS, Machado CM, Agena F, Latif AZ, Alencar CS, Pierrotti LC, Nahas WC, Caiaffa-Filho HH, Pannuti CS. A double-blinded, prospective study to define antigenemia and quantitative real-time polymerase chain reaction cutoffs to start preemptive therapy in low-risk, seropositive, renal transplanted recipients. Transplantation. 2014 Nov 27;98(10):1077-81. doi: 10.1097/TP.0000000000000189.

  PMID: 24839894 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.

  PMID: 22179399 BACKGROUND

• Fernandez-Ruiz M, Gimenez E, Vinuesa V, Ruiz-Merlo T, Parra P, Amat P, Montejo M, Paez-Vega A, Cantisan S, Torre-Cisneros J, Fortun J, Andres A, San Juan R, Lopez-Medrano F, Navarro D, Aguado JM; Group for Study of Infection in Transplantation of the Spanish Society of Infectious Diseases and Clinical Microbiology (GESITRA-SEIMC) and the Spanish Network for Research in Infectious Diseases (REIPI). Regular monitoring of cytomegalovirus-specific cell-mediated immunity in intermediate-risk kidney transplant recipients: predictive value of the immediate post-transplant assessment. Clin Microbiol Infect. 2019 Mar;25(3):381.e1-381.e10. doi: 10.1016/j.cmi.2018.05.010. Epub 2018 May 25.

  PMID: 29803844 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.

  PMID: 23311355 BACKGROUND

• Gibson L. An Interferon-gamma Release Assay for Evaluation of Cell-mediated Immunity in Infants With Congenital Cytomegalovirus Infection. Clin Infect Dis. 2021 Aug 2;73(3):374-375. doi: 10.1093/cid/ciaa700. No abstract available.

  PMID: 32504089 DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Elias David-Neto, MD, PhD

  Instituto do Coracao

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose O Reusing Junior, MD

CONTACT

+551126618089; jotto@usp.br

Fabiana Agena, N

CONTACT

+551126618089; fabiana.agena@hc.fm.usp.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: March 1, 2019
• Study Start: August 5, 2018
• Primary Completion: August 5, 2020
• Study Completion: November 30, 2020
• Last Updated: March 1, 2019

Record last verified: 2019-02

Locations

BR (1)