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

October 1, 2020 updated by: Amir Abdipour, MD, Loma Linda University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult kidney recipients who are determined to have BK viremia post-transplant

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
New Protocol to treat BK viremia or BKVAN
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
Other: New Protocol - BK viremia or BK virus nephropathy
Data collected prospectively that will follow new clinical practice guidelines that were developed by Loma Linda Nephrology group with collaboration with Transplant surgeons to improve care of patients complicated with BK viremia or BK virus nephropathy.
Standard Protocol to treat BK viremia or BKVAN
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
Other: Standard Protocol - BK viremia or BK virus nephropathy
Data collected retrospectively that followed standard clinical practice guidelines that were developed by Loma Linda Nephrology group with collaboration with Transplant surgeons to improve care of patients complicated with BK viremia or BK virus nephropathy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Amir Abdipour, MD, Loma Linda University Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

March 2, 2016

First Submitted That Met QC Criteria

April 28, 2016

First Posted (Estimate)

May 2, 2016

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

October 1, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5150278

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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