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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
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

April 4, 2012
April 6, 2012
April 4, 2014
November 2011
November 2012   (Final data collection date for primary outcome measure)
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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Complete list of historical versions of study NCT01573039 on ClinicalTrials.gov Archive Site
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Cut Off for the Diagnosis of Cytomegalovirus (CMV) Disease in Serum-positive Kidney Transplant Recipients
Definition of Cut Off for PCR - Quantitative and Antigenemia in the Diagnosis of Cytomegalovirus (CMV) Disease in Serum-positive Kidney Transplant Recipients
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Kidney transplant recipients
Cytomegalovirus Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
140
July 2013
November 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
14 Years to 75 Years   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01573039
CAPPesq 0045/11
Yes
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University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
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Principal Investigator: Elias David-Neto, MD University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
January 2013