Natural History of Cytomegalovirus (CMV) Infection and Disease Among Renal Transplant Recipients

NCT01833416 | Completed

• 1 other identifier: 2013027692
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Although the accumulated knowledge regarding Cytomegalovirus (CMV) infection increased substantially over the past years, several issues still deserve further investigation. The epidemiology of this disease has been changing, perhaps influenced by new immunosuppressive strategies currently used and growing and widespread use of prophylaxis. The knowledge of the CMV viral load kinetics, using a polymerase chain reaction (PCR-based assay), among renal transplant recipients not receiving any prophylactic therapy will allow the determination of risk factors for and the impact of earlier intervention on CMV infection and disease. The goal is to ultimately improve the clinical outcomes for renal transplant recipients.

Conditions

Infection in Solid Organ Transplant Recipients

Keywords

CMV infection; CMV disease; Natural history; Kidney transplant

Outcome Measures

Primary Outcomes (1)

• Incidence of cytomegalovirus(CMV)infection and disease among renal transplant recipients receiving preemptive therapy.

  There is still a debate regarding the superiority strategy with valganciclovir over the preemptive approach. Furthermore, this costly therapy or any other CMV prophylaxis is currently not reimbursed by our unified public health system. Therefore our strategy has been to use preemptive therapy.

  3 months

Secondary Outcomes (5)

• Change from baseline clinical and epidemiological aspects of CMV infection in this kidney transplant population.

  3 months

• Incidence of the CMV viral load kinetics using a PCR-based assay among renal transplant recipients.

  3 months

• The ideal time to start preemptive anti-CMV therapy.

  3 months

• Baseline factors that can predict those patients at risk for developing a CMV viral load parameter that correlates with development of a detectable CMV antigen.

  3 months

• Risk factors associated with prolonged treatment and recurrence of CMV infection or disease.

  3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All male and female de novo kidney transplant recipients

You may qualify if:

• Informed consent.
• Male/female patients at least 18 years old who will be followed at our outpatient clinic for at least one year.
• Recipients of first or repeat kidney transplants from living or deceased donors.

You may not qualify if:

• Recipients of any combined transplant (kidney/pancreas, kidney liver).
• Unlikely to comply with the requirements of the study.

Sponsors & Collaborators

• Helio Tedesco Silva Junior: lead

Study Sites (1)

Hospital do Rim e Hipertensao

São Paulo, São Paulo, 04038002, Brazil

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Helio T Silva-Junior, MD

  Hospital do Rim e Hipertensao

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: April 16, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 23, 2015

Record last verified: 2015-03

Locations

BR (1)