BK Treatment Study

Mass General Brigham logo

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

Trial contacts and locations

8

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems