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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01573039
First received: April 4, 2012
Last updated: April 3, 2014
Last verified: January 2013
  Purpose

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
Cytomegalovirus Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: November 2011
Study Completion Date: July 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   14 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Kidney transplant recipients

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573039

Locations
Brazil
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
Investigators
Principal Investigator: Elias David-Neto, MD University of Sao Paulo General Hospital
  More Information

No publications provided

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01573039     History of Changes
Other Study ID Numbers: CAPPesq 0045/11
Study First Received: April 4, 2012
Last Updated: April 3, 2014
Health Authority: Brazil: National Committee of Ethics in Research

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

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

ClinicalTrials.gov processed this record on April 15, 2014