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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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