BK Treatment Study

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: BK Viremia

Treatments: Drug: levofloxacin; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01034176

2009p000020

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

43 participants in 2 patient groups, including a placebo group

Levofloxacin

Active Comparator group

Description:

Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days

Treatment:

Drug: levofloxacin

placebo

Placebo Comparator group

Description:

placebo identical to levofloxacin drug daily for 30 days

Treatment:

Drug: placebo