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Cut Off for the Diagnosis of Cytomegalovirus (CMV) Disease in Serum-positive Kidney Transplant Recipients

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ClinicalTrials.gov Identifier: NCT01573039
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : April 4, 2014
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief Summary:
CMV disease is a challenge to the success of renal transplantation. Recently, the investigators analyzed data from 792 renal transplant recipients performed at our hospital between 1999 and 2005. After the usual exclusions, 663 patients were analyzed. This population showed that the incidence of CMV disease is stable and occurs in approximately 20-22% of all patients and invasive disease in approximately 5% every year. In seronegative patients and those receiving anti-lymphocyte (AL), CMV prophylaxis, done with ganciclovir for 90 days is our routine and in the majority of transplant centers. In seropositive patients without associated risk factors (such as the use of AL) universal prophylaxis is not done. Rather, in this group, early diagnosis, by detection of antigenemia or viremia by quantitative PCR, is performed in patients who show symptoms compatible with CMV disease. In the investigators analysis the incidence of CMV disease in seropositive patients is around 16%. These patients are usually hospitalized and treated with GCV IV for 14-21 days. This leads to an additional costs of admissions, biopsies for the diagnosis of disease invasion, etc. Besides these costs, the survival of the grafts in the long run is lower in patients with CMV disease than in those without CMV, particularly when associated with acute rejection. In recent years, monitoring of viremia (PCR / antigenemia) and preemptive treatment when it reaches substantial values, have increasingly been suggested. Patients in whom the detection of viremia in progressive values is detected would be treated as outpatients before the disease develops. To turn this hypothesis into reality, there is an urgent need to define cutoff values for CMV-PCR in the detection of developing CMV disease.

Condition or disease
Cytomegalovirus Disease

Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Definition of Cut Off for PCR - Quantitative and Antigenemia in the Diagnosis of Cytomegalovirus (CMV) Disease in Serum-positive Kidney Transplant Recipients
Study Start Date : November 2011
Primary Completion Date : November 2012
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Establish a cutoff for viremia, antigenemia detected by PCR and quantitative-to event for CMV disease. [ Time Frame: Day 0,7,14,21,28,35,42,56,63, 70,77,84,91,98, 105,112,120 ]

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Ages Eligible for Study:   14 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Kidney transplant recipients

Inclusion Criteria:

  • Patients over 14 years and younger than 75 years
  • Seropositive for CMV (IgG)
  • Kidney transplant recipients

Exclusion Criteria:

  • Patients who received anti-lymphocyte induction
  • Patients with organ transplants double

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01573039

Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo
Sao Paulo, Brazil, 05403-900
Sponsors and Collaborators
University of Sao Paulo General Hospital
Principal Investigator: Elias David-Neto, MD University of Sao Paulo General Hospital

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01573039     History of Changes
Other Study ID Numbers: CAPPesq 0045/11
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: April 4, 2014
Last Verified: January 2013

Keywords provided by University of Sao Paulo General Hospital:
Kidney transplantation
PCR quantitative

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases