WithdrawnNot Applicable

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

United States0Started 2015-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Trial details

NCT IDNCT02758288

SponsorLoma Linda University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-07

View on ClinicalTrials.gov More BK Virus Infection trials