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

NCT02758288 | Withdrawn

• 1 other identifier: 5150278
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

BK Virus Infection; BK Virus Nephropathy

Keywords

Kidney transplant; BK Viremia; BK Nephropathy

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (4)

• Rate of BK nephropathy in both treatment groups confirmed by kidney biopsy

  24 months

• Rate of acute cellular or humoral rejection 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

Study Arms (2)

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

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

Interventions

New Protocol - BK viremia or BK virus nephropathy OTHER

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.

New Protocol to treat BK viremia or BKVAN

Standard Protocol - BK viremia or BK virus nephropathy OTHER

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.

Standard Protocol to treat BK viremia or BKVAN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Related Publications (47)

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Study Officials

• Amir Abdipour, MD

  Loma Linda University Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: May 2, 2016
• Study Start: September 1, 2015
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2022
• Last Updated: October 5, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)