BK Virus Infection Clinical Trial
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
NCT number | NCT02758288 |
Other study ID # | 5150278 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | July 2022 |
Verified date | October 2020 |
Source | Loma Linda University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 2022 |
Est. primary completion date | July 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Loma Linda University Medical Center | Loma Linda | California |
Lead Sponsor | Collaborator |
---|---|
Loma Linda University |
United States,
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* Note: There are 47 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Rate of BK nephropathy in both treatment groups confirmed by kidney biopsy | 24 months | ||
Secondary | Rate of acute cellular or humoral rejection in both treatment groups confirmed by kidney biopsy | 24 months | ||
Secondary | Rate of graft loss in both group as determined by elevated creatinine level and kidney biopsy | 24 months | ||
Secondary | 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 |
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