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OpenTrials
Completed

NCT Number: NCT01034176

BK Treatment Study

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.

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Key information

Conditions

BK Viremia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levofloxacin

Drug

500 mg tablet, daily, 30 days

Other names: Levaquin

Placebo

Drug

no dose, tablet, daily, 30 days

Primary outcomes

  1. Percent Change From Baseline in BK Virus Copies at 3 Months

    Time frame: Baseline and 3 months

    Percent change in BK virus copies/mL from Baseline to 3 months

Secondary outcomes

  1. Number of Patients With >50% Reduction in BK Virus Copies

    Time frame: Baseline and 6 months

    Number of patients with >50% reduction in BK viral load at 6 months

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Effect of Fluoroquinolones on BK Viremia in the Renal Transplant Recipient, A Multi-Center Study

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 17, 2009
Registry last updated
Apr 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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