RECRUITING

Immune Registry for BK in Kidney Transplant Recipients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Kidney transplantation (KT) is the best treatment modality available to date for patients with advanced kidney disease and the success of KT is dependent on maintaining a selective intricate balance between the risk of rejection and infections in KT recipients. BK virus is an important clinical infection affecting the post-transplant outcomes in KT recipients. BK nephropathy can affect 8-15% of patients after KT causing acute kidney injury, increased risk of rejection and fibrosis leading to additional hospital stays, increasing overall health care cost burden, and in some cases graft loss. The exact pathogenesis and treatment options for BK nephropathy are not clearly understood. It is debatable whether BK nephropathy is a full fledge donor-derived infection or reactivation of the recipient's latent infection. Irrespective of etiology, the common consensus is that treatment of BK virus infection depends on the selective restoration of host immune responses and balancing the risk of rejection vs worsening of infection.

Official Title

Immune Registry for BK (Polyomavirus Hominis 1) in Kidney Transplant Recipients

Quick Facts

Study Start:2024-05-29
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06538961

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult (\>18 years old) male and female, deceased donor KT recipients
  2. * Will include single organ transplants.
  3. * Each participant must also have recently been diagnosed with BK viremia.
  4. * In addition to the aforementioned inclusion criteria, each participant in the substudy must also have recently been diagnosed with BK viremia
  1. * Prisoners will not be included in the study
  2. * Multi-organ transplants and pregnant women

Contacts and Locations

Study Contact

Ambreen Azhar
CONTACT
804-828-4104
ambreen.azhar@vcuhealth.org
Gelila Abebe
CONTACT
(804) 628-4969
gelila.abebe@vcuhealth.org

Principal Investigator

Ambreen Azhar
PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University

Study Locations (Sites)

Virginia Commonwealth University
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

  • Ambreen Azhar, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-29
Study Completion Date2026-05

Study Record Updates

Study Start Date2024-05-29
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

  • Immune Registry

Additional Relevant MeSH Terms

  • BK Virus Infection
  • Kidney Transplant; Complications