What this study is
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.
What's being tested
- Blood samples: Main Study group
Intervention · OTHER
the collection of blood samples at specified time points.
- Data Collection
Intervention · OTHER
Donor and Recipient's clinical information including clinical history, demographic characteristics labs, and imaging.
- Urine Sample- Main Study group
Intervention · OTHER
-Post-transplant monthly urine sample collection for 6 months in 10-18% of subjects
- Urine sample- Sub-study group
Intervention · OTHER
- Post-transplant monthly urine sample collection for 6 months in all subjects
- Blood sample: Sub-study group
Intervention · OTHER
Monthly blood sample collection for 6 months
Study details
- Official title
- Immune Registry for BK (Polyomavirus Hominis 1) in Kidney Transplant Recipients
- Sponsor
- Virginia Commonwealth University
- Conditions
- BK Virus Infection · Kidney Transplant; Complications
- Enrolling
- 60 people
- Starts
- 2024-05-29
- Est. completion
- 2027-07
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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.
- In addition to the aforementioned inclusion criteria, each participant in the sub-study must also have recently been diagnosed with BK viremia or have difficult-to-treat BKV > 3 logs (BKV log does not decrease by more than 1 log copy/ml drop on second per protocol lab).
You can't join if
- Prisoners will not be included in the study
- Multi-organ transplants and pregnant women
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openVirginia Commonwealth University
Richmond, Virginia, United States
- Ambreen Azhar · Contact804-828-4104ambreen.azhar@vcuhealth.org
- Gelila Abebe · Contact804-628-4969gelila.abebe@vcuhealth.org
- Gaurav Gupta · Principal investigator
Recruiting
Study team
Sponsor
Virginia Commonwealth University
Study ID HM20028057
Principal investigator
Ambreen Azhar
Virginia Commonwealth University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.