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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02758288
Recruitment Status : Withdrawn
First Posted : May 2, 2016
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Amir Abdipour, MD, 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.

Condition or disease Intervention/treatment
BK Virus Infection BK Virus Nephropathy Other: New Protocol - BK viremia or BK virus nephropathy Other: Standard Protocol - BK viremia or BK virus nephropathy

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Other
Time Perspective: Prospective
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 Start Date : September 2015
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Rate of BK nephropathy in both treatment groups confirmed by kidney biopsy [ Time Frame: 24 months ]
  2. Rate of acute cellular or humoral rejection in both treatment groups confirmed by kidney biopsy [ Time Frame: 24 months ]
  3. Rate of graft loss in both group as determined by elevated creatinine level and kidney biopsy [ Time Frame: 24 months ]
  4. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult kidney recipients who are determined to have BK viremia post-transplant
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758288


Locations
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United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Amir Abdipour, MD Loma Linda University Health
Publications:

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Responsible Party: Amir Abdipour, MD, Assistant Professor of Medicine, Loma Linda University
ClinicalTrials.gov Identifier: NCT02758288    
Other Study ID Numbers: 5150278
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Amir Abdipour, MD, Loma Linda University:
Kidney transplant
BK Viremia
BK Nephropathy
Additional relevant MeSH terms:
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Virus Diseases
Kidney Diseases
Urologic Diseases