BK Virus Post-Kidney Transplant: New Practice Versus Traditional Approach

Withdrawn

• Conditions: BK Virus Nephropathy; BK Virus Infection
• Interventions: Other: Standard Protocol - BK viremia or BK virus nephropathy; Other: New Protocol - BK viremia or BK virus nephropathy

• Registration Number: NCT02758288
• Lead Sponsor: Loma Linda University

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-05-02
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-01
• Last Update Posted: 2020-10-05
• Primary Completion: 2021-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard Protocol to treat BK viremia or BKVAN	Standard Protocol - BK viremia or BK virus nephropathy	Adult kidney recipients who are determined to have BK viremia with a BK PCR viral load over 500 copy post-transplant treated with a traditional standard of care protocol, retrospective data collection approach
New Protocol to treat BK viremia or BKVAN	New Protocol - BK viremia or BK virus nephropathy	Adult kidney recipients who are determined to have BK viremia with a BK PCR viral load over 500 copy post-transplant treated with a new treatment protocol, prospective data collection approach

Primary Outcome Measures

Name	Time	Method
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.	12 months

Secondary Outcome Measures

Name	Time	Method
Rate of BK nephropathy in both treatment groups confirmed by kidney biopsy	24 months
Rate of graft loss in both group as determined by elevated creatinine level and kidney biopsy	24 months
Estimated glomerular filtration rate (eGFR) at start of the study (0) , 3, 6, 12 and 24 months between two groups	3, 6, 12, 24 months
Rate of acute cellular or humoral rejection in both treatment groups confirmed by kidney biopsy	24 months

Trial Locations

Locations (1)

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States