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Immune Registry for BK in Kidney Transplant Recipients

NCT06538961 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-02-27

No results posted yet for this study

Summary

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.

Conditions

  • BK Virus Infection
  • Kidney Transplant; Complications

Interventions

OTHER

Blood samples: Main Study group

the collection of blood samples at specified time points.

OTHER

Data Collection

Donor and Recipient's clinical information including clinical history, demographic characteristics labs, and imaging.

OTHER

Urine Sample- Main Study group

-Post-transplant monthly urine sample collection for 6 months in 10-18% of subjects

OTHER

Urine sample- Sub-study group

\- Post-transplant monthly urine sample collection for 6 months in all subjects

OTHER

Blood sample: Sub-study group

Monthly blood sample collection for 6 months

Sponsors & Collaborators

  • Eurofins

    collaborator INDUSTRY

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Ambreen Azhar · Virginia Commonwealth University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-29
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06538961 on ClinicalTrials.gov