Immune Registry for BK in Kidney Transplant Recipients

NCT06538961 | Recruiting

• 1 other identifier: HM20028057
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Immune Registry; BK in Kidney Transplant Recipients

Outcome Measures

Primary Outcomes (1)

• Assessing the effect of kidney transplant immunosuppression therapy on the immune response against BK virus

  Assessing the effect of kidney transplant induction and maintenance triple immunosuppression on humoral and cellular responses against BK virus compared at pre- and post-KT through clinical chart review, abnormal value or result from a clinical or laboratory evaluation, by assessing humoral and cellular responses against BK virus through BK specific T cell response, immunoglobulin G targeting BK levels, urine gene expression test to detect for BK virus and rejection.

  24 months

Secondary Outcomes (1)

• To identify the frequency risk of BK viremia

  24 month

Study Arms (2)

Main study

Single organ deceased donor kidney transplant recipients. Main study group subjects are enrolled at the time of transplant.

Other: Blood samples: Main Study group; Other: Data Collection; Other: Urine Sample- Main Study group

Sub-study

Single organ deceased donor Kidney Transplant Recipient who are newly diagnosed with BK Viremia or those with difficult-to-treat BKV \> 3 logs (BKV log does not decrease by more than 1 log copy/ml drop on second per protocol lab). The sub-study group are enrolled once they are diagnosed with BK viremia post-transplant.

Other: Data Collection; Other: Urine sample- Sub-study group; Other: Blood sample: Sub-study group

Interventions

Blood samples: Main Study group OTHER

the collection of blood samples at specified time points.

Main study

Data Collection OTHER

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

Main study; Sub-study

Urine sample- Sub-study group OTHER

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

Sub-study

Blood sample: Sub-study group OTHER

Monthly blood sample collection for 6 months

Sub-study

Urine Sample- Main Study group OTHER

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

Main study

Eligibility Criteria

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

Study Population

The study will include adults 18 and older who have undergone single organ deceased donor Kidney Transplant.

You may qualify if:

• Adult (\>18 years old) male and female, deceased donor KT recipients
• Will include single organ transplants.
• Each participant must also have recently been diagnosed with BK viremia.

You may not qualify if:

• Prisoners will not be included in the study
• Multi-organ transplants and pregnant women

Sponsors & Collaborators

• Eurofins: collaborator
• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. Biospecimens(blood) will be drawn for research purpose. 2. Urine specimen collection Main study cohort: * specimen to assess BK-specific T cell immune responses will be collected at the time of transplant, 1 month, 2 month 3 month and 6 month post-transplant. * specimen to assess BK antibody responses will be collected at the time transplant, 3 month and 6 month post-transplant. * Uromap (urine gene expression test to detect for BK virus and rejection) will be performed on monthly basis for 6 months post-transplant in 10-18% of subjects. Sub-Study cohort: * specimen to assess BK-specific T cell immune responses and BK antibody responses will be collected on monthly basis for 6 month. * Uromap (urine gene expression test to detect for BK virus and rejection) will be performed on monthly basis for 6 months.

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ambreen Azhar

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ambreen Azhar

CONTACT

804-828-4104; ambreen.azhar@vcuhealth.org

Gelila Abebe

CONTACT

(804) 628-4969; gelila.abebe@vcuhealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: August 6, 2024
• Study Start: May 29, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)