Clinical trial NCT02758288: BK Virus Post-Kidney Transplant: New Practice Versus Traditional Approach
Official title: BK Viremia and BK Virus Nephropathy Post Kidney Transplant Comparison of New Practices With Traditional Approach: A Combined Retrospective Chart Review and Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: BK Virus Infection
BK Virus Nephropathy
Keywords: Kidney transplant
BK Viremia
BK Nephropathy
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2016-05-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult kidney recipients who are determined to have BK viremia post-transplant

Brief summary: The investigator's aim in this study is to evaluate the impact of a new standard of care protocol for the treatment of BK viremia and nephropathy (BKVAN), which includes switching from Tacrolimus to equivalent dose of Cyclosporine in patients who have been diagnosed with BK viremia or BKVAN based on their viral load, overall graft function (estimated glomerular filtration rate), acute rejection, and rate of graft loss due to rejection or BKVAN.

Detailed description: This study will be a combined retrospective chart review and prospective observational study. This will be a single center project that will take place at Loma Linda University Transplant Institute. All adult kidney recipients who are determined to have BK viremia with a BK PCR viral load over 500 copy post-transplant and meet the inclusion criteria but no exclusion criteria will be enrolled and observed per study protocol.

All kidney transplant recipients are routinely assessed for BK virus nephropathy and viremia post transplant as part of their standard care. Patients with BK viremia or BK virus nephropathy will have adjustments in their immunosuppressive medication based on current guidelines and recommendations which include reduction in immunosuppression, treatment with medications with antiviral activity (Cidofovir, Ciprofloxacin, Leflunomide, IVIG) or switching from a Tacrolimus (Prograf)-based regimen to a Cyclosporine-based regimen. Retrospectively, the investigator will collect data on patients who have been diagnosed with BK viremia or BK virus nephropathy and have had such a management in past 66 months (from 1/1/2010 till 06/30/2015). Prospectively, the investigator will enroll and collect data on patients who will be treated for BK viremia or BK virus nephropathy.

As standard of care, all kidney transplant recipients will be seen routinely on weekly-biweekly basis in post-transplant clinic for up to 3 months then every 3 months for up to a year and yearly thereafter. All kidney transplant recipients will be monitored for BK viremia by having blood PCR tested on a monthly basis at 1, 2, 3, 6, and 12 months after transplant. Also, all patients post-kidney transplant will be tested for BK viremia if there is an acute rise in their creatinine.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Recipient of kidney or combined kidney and pancreas

  * BK viremia confirmed with blood PCR test with viral load over 500
  * BK virus nephropathy confirmed by kidney biopsy

Exclusion Criteria:

* Recipient of combined organ transplant except kidney and pancreases
* Patient age \< 18 years
* If patient does not consent for kidney biopsy
* Currently on treatment for acute rejection
* Patients with HIV, Hep C or Hep B infection
* Patients who are on other immunosuppression beside our standard regimen which includes Prograf, cellcept / Myfortic and prednisone

Primary outcomes:
measure: Kidney function to compare effectiveness of a new care protocol for the treatment of BK viremia (BK PCR viral load over 500 copy) and BKVAN (confirmed by kidney biopsy) with a similar cohort treated with traditional methods.
timeFrame: 12 months
Secondary outcomes:
measure: Rate of BK nephropathy in both treatment groups confirmed by kidney biopsy
timeFrame: 24 months
measure: Rate of acute cellular or humoral rejection in both treatment groups confirmed by kidney biopsy
timeFrame: 24 months
measure: Rate of graft loss in both group as determined by elevated creatinine level and kidney biopsy
timeFrame: 24 months
measure: Estimated glomerular filtration rate (eGFR) at start of the study (0) , 3, 6, 12 and 24 months between two groups
timeFrame: 3, 6, 12, 24 months
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
affiliation: Loma Linda University Health
name: Amir Abdipour, MD
role: PRINCIPAL_INVESTIGATOR
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