NCT02550639

Brief Summary

The aim of this prospective, randomized study is to assess a subject's immunological status against hCMV before kidney transplantation by an hCMV-specific interferon (INF)-γ ELISPOT technique confirming previous results and establishing their statistical validity in order to determine whether this test could be used routinely in clinical practice to assess the risk of developing hCMV infection after renal transplantation and, ultimately, identify the most effective individual antiviral therapeutic strategy against hCMV.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2014

Longer than P75 for phase_4

Geographic Reach
2 countries

5 active sites

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

Study Start

First participant enrolled

February 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 3, 2018

Status Verified

October 1, 2018

Enrollment Period

4.6 years

First QC Date

September 14, 2015

Last Update Submit

October 2, 2018

Conditions

CMV InfectionKidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • iNCIDENCE OF hCMV INFECTION

    The primary study endpoint is the incidence of hCMV infection in patients receiving Pre-emptive treatment in either group (positive or negative ELISPOT).

    12 MONTHS

Study Arms (4)

A1-prophylaxis group,positive elispot test

ACTIVE COMPARATOR

POSITIVE ELISPOT TEST, PROPHYLAXIS GROUP (CMV PROPHYLAXIS)

Other: BIOMARKER- elispot test

A2- preemptive group,positive elispot test

EXPERIMENTAL

POSITIVE ELISPOT TEST, PREEMPTIVE GROUP (NO CMV PROPHYLAXIS)

Other: BIOMARKER- elispot test

B1- prophylaxis group,negative elispot test

ACTIVE COMPARATOR

NEGATIVE ELISPOT TEST, PROPHYLAXIS GROUP (CMV PROPHYLAXIS)

Other: BIOMARKER- elispot test

B2- preemptive group,negative elispot test

EXPERIMENTAL

NEGATIVE ELISPOT TEST, PREEMPTIVE GROUP (NO CMV PROPHYLAXIS)

Other: BIOMARKER- elispot test

Interventions

BIOMARKER- elispot testOTHER

ELISPOT TEST

A1-prophylaxis group,positive elispot testA2- preemptive group,positive elispot testB1- prophylaxis group,negative elispot testB2- preemptive group,negative elispot test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult renal transplant patients fulfilling the following criteria will be included:
  • Subjects must be ≥ 18 years old, with a body weight \> 34 kg and of either sex or any race.
  • Subjects must be seropositive for hCMV and must receive a renal graft from a seropositive donor (IgG positive).
  • A pre-transplant blood sample is available from the recipient to carry out an hCMV-specific ELISPOT test.
  • Subjects must be capable of, and willing to provide written informed consent to participate in the study. Subjects unable to provide written informed consent by themselves may be consented through their legal representative.
  • Females of child bearing potential must have a pregnancy test before enrolment and be willing to use a medically acceptable birth control method during the screening period and while they receive study medication.

You may not qualify if:

  • An inconclusive hCMV ELISPOT or unavailability of recipient samples.
  • History of type I hypersensitivity reactions or idiosyncratic reactions to ganciclovir (GCV)/valganciclovir (VGCV).
  • Pregnant women.
  • Lactating women.
  • Subjects must not have any clinically significant disease which could interfere with study procedures.
  • Participation in another industry-sponsored clinical study where treatment for CMV is already specified by the study protocol.
  • Patients having received other non-renal transplants.
  • Patients with evidence of active Hepatitis C virus (HCV), Hepatitis B virus (HBV) and/or HIV viral replication.
  • Maintenance immunosuppressive therapy which includes mammalian target of rapamycin (mTOR) inhibitors.
  • Patients requiring desensitization treatment such as plasmapheresis, Campath-1, Rituximab®, Eculizumab® and/or Gammaglobulin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hôpital Erasme- Cliniques Universitaires de Bruxelles,

Brussels, Belgium

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitari de la Vall d'Hebrón

Barcelona, 08035, Spain

Location

Hospital Clinic i Provincial

Barcelona, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Spain

Location

Related Publications (3)

  • Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4.

    PMID: 39807668DERIVED

  • Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.

    PMID: 38700045DERIVED

  • Jarque M, Crespo E, Melilli E, Gutierrez A, Moreso F, Guirado L, Revuelta I, Montero N, Torras J, Riera L, Meneghini M, Taco O, Manonelles A, Paul J, Seron D, Facundo C, Cruzado JM, Gil Vernet S, Grinyo JM, Bestard O. Cellular Immunity to Predict the Risk of Cytomegalovirus Infection in Kidney Transplantation: A Prospective, Interventional, Multicenter Clinical Trial. Clin Infect Dis. 2020 Dec 3;71(9):2375-2385. doi: 10.1093/cid/ciz1209.

    PMID: 32076718DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Oriol Bestard, MD, PhD

    Hospital Universitari de Bellvitge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 14, 2015

First Posted

September 15, 2015

Study Start

February 1, 2014

Primary Completion

September 1, 2018

Study Completion

October 1, 2018

Last Updated

October 3, 2018

Record last verified: 2018-10

Locations

BE(1)ES(4)