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

Cytomegalovirus Disease Clinical Trial

Official title:

Definition of Cut Off for PCR - Quantitative and Antigenemia in the Diagnosis of Cytomegalovirus (CMV) Disease in Serum-positive Kidney Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01573039
• Other study ID #: CAPPesq 0045/11
• Status: Completed
• Phase: N/A
• First received: April 4, 2012
• Last updated: April 3, 2014
• Start date: November 2011
• Est. completion date: July 2013

Study information

• Verified date: January 2013
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cytomegalovirus Disease
• Cytomegalovirus Infections

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish a cutoff for viremia, antigenemia detected by PCR and quantitative-to event for CMV disease.		Day 0,7,14,21,28,35,42,56,63, 70,77,84,91,98, 105,112,120	Yes