BK Virus Infection (Viremia) Natural History in Renal Transplant Recipients

This study has been terminated.
(This study is being withdrawn from Clinicaltrials.gov because it is not an ACT.)
Sponsor:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01782209
First received: January 30, 2013
Last updated: May 19, 2014
Last verified: January 2014
  Purpose

The objectives of this study is to establish the natural history of BK virus viremia and other possible opportunistic viral pathogens in renal transplants receipients.


Condition
BK Virus (BKV) Viremia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Natural History of Infection Caused by BK Virus (and Other Opportunistic Viral Pathogens) in Renal Transplant Recipients

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Incidence of BKV viremia in the study population of screened renal or renal-pancreas transplant subjects [ Time Frame: within 4 weeks and up to 24 months after renal transplant ] [ Designated as safety issue: No ]
    We will measure the number of subjects screened who developes BK viremia within 4 weeks and up to 24 months after renal transplant


Secondary Outcome Measures:
  • Time to onset of BK viremia [ Time Frame: Within 4 weeks and up to 24 months after renal transplant ] [ Designated as safety issue: No ]
    We will measure the number of days until BK viremia is diagnosed

  • Duration of BK viremia after diagnosis in renal transplant population [ Time Frame: Within 4 week up to 24 months after renal transplant ] [ Designated as safety issue: No ]
    We will measure the length of time from onset to resolution of BK viremia after renal transplant

  • Incidence of BKVN in study population [ Time Frame: Within 4 weeks up to 24 months after renal transplant in study population ] [ Designated as safety issue: No ]
    We will measure the occurance of increased serum creatinine and record data from pathologic examination of renal allograft

  • Quantitative measurment of BV viremia over time [ Time Frame: Within 4 weeks up to 24 months after renal transplant ] [ Designated as safety issue: No ]
    We will measure the number of BK viral DNA found in plasma laboratory specimens over time after diagnosis of BK viremia in renal transplant study population.

  • Association of BK viremia with immunosupressive therapy (drug, doses, blood concentrations) [ Time Frame: Within 4 weeks and up to 24 months after renal transplant ] [ Designated as safety issue: No ]
    We will measure the diagnosis of BK viremia in relations to the immunosuppressant drug, dose, and blood levels over time until resolution of BK viremia

  • Association of BK viremia with donor/recipient HLA matching [ Time Frame: Within 4 weeks and up to 24 months after transplant ] [ Designated as safety issue: No ]
    We will measure the incidence of BK viremia diagnosis relative to renal transplant study population donor/recipient HLA matching.

  • Association of BK viremis with recipient demographic features [ Time Frame: Within 4 weeks and up to 24 months after renal transplant ] [ Designated as safety issue: No ]
    We will measure the incidence of BK viremia diagnosis relative to renal transplant study population demographic features (gender, age, ethnicity/race).


Biospecimen Retention:   Samples With DNA

Whole blood samples will be processed for serum and then evaluated for BK virus DNA


Estimated Enrollment: 450
Study Start Date: June 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Detailed Description:

This is a Natural History study in renal or renal-pancreas transplant recipients. In an effort to capture patients early in the course of an evolving BK virus infection and avoid patients who have already developed evidence of BKV-induced nephropathy (BKVN), this protocol will emphasize the initiation of screening in the early post-transplant period. Patients who have undergone renal or renal/pancreas transplantation within 4 weeks, but not more than 90 day previously, will be asked to participate and then consented to be enrolled in a Natural History-Surveillance period for up to approximately 24 months. Participants enrolled in this study will provide valuable natural history data regarding BKV viremia, and potentially other viral pathogen, in the post-renal transplant period. Participants will provide blood samples to undergo measurement for plasma BKV DNA by PCR approximately every 6 weeks, to be resulted in real time at the UAB Diagnostic Virology Laboratory at UAB.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Male and female renal or renal-pancreas transplant recipients ages 18 and older at risk for BKV infection

Criteria

Inclusion Criteria:

Renal or renal-pancreas transplant patients who are within 4 weeks and not more than 90 days post-transplant with or without qualifying BKV viremia Age greater than or equal to 18 years; Provides written informed consent.

Exclusion Criteria:

Evidence of proven or suspected BKVN by clinical or pathologic diagnostic criteria Loss of renal graft function Initiation of chronic dialysis

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782209

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, California
California Pacific Medical Center
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado at Denver and HSC
Denver, Colorado, United States, 80045
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University, Barnes Jewish Hospital
St. Louis, Missouri, United States
United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: John W Gnann, MD University of Birmingham at Alabama
  More Information

No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01782209     History of Changes
Other Study ID Numbers: DMID 11-0071
Study First Received: January 30, 2013
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
BK virus viremia
renal transplant
other viral pathogens

Additional relevant MeSH terms:
Virus Diseases
Viremia
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014