CompletedPhase 4

BK Treatment Study

United States43 participantsStarted 2009-02

Plain-language summary

Our hypothesis is that 30 days of oral levofloxacin (FDA approved antibiotic) in patients with persistent viremia (BK virus found in blood) will impair progress to BK virus induced kidney damage by significantly decreasing or eliminating BK virus in the blood.

Who can participate

Age range18 Years

SexALL

See this in plain English?

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

Inclusion Criteria: * Living and cadaveric kidney transplant recipients over the age of 18 years with BK viremia Exclusion Criteria: * Female patients of childbearing age who are pregnant or in whom adequate contraception cannot be maintained. * Patients with active infections, history of malignancy/Posttransplant Lymphoproliferative Disease (PTLD) serologic positivity to HIV. * Patients with evidence of urinary tract obstruction causing allograft dysfunction, unless corrected by time of enrollment. * Patients with clinical or morphological evidence of recurrence of primary disease. * Patients with a history of allergic reaction to quinolone antibiotics. * Patients with history of prolong QT interval * Patients with recurrent hypoglycemic episodes * Patients with history of myasthenia gravis * Patients taking Thioridazine

What they're measuring

Percent Change From Baseline in BK Virus Copies at 3 Months

Timeframe: Baseline and 3 months

Trial details

NCT IDNCT01034176

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-06

Results submitted2014-01-21

View on ClinicalTrials.gov More BK Viremia trials