BK Treatment Study

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen by Anil Chandraker, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Brigham and Women's Hospital

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Anil Chandraker, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

Inclusion Criteria

Living and cadaveric kidney transplant recipients over the age of 18 years with BK viremia

Treatment Details

Interventions

• Levofloxacin (Fluoroquinolone Antibiotic)
• Placebo (Other)

Participant Groups

Group I: Levofloxacin Active Control 1 Intervention

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

Group II: placebo Placebo Group 1 Intervention

placebo identical to levofloxacin drug daily for 30 days

Levofloxacin is already approved in Canada, Japan for the following indications:

Approved in Canada as Levofloxacin for:

• Community-acquired pneumonia
• Urinary tract infections
• Skin and skin structure infections
• Chronic bacterial prostatitis
• Acute pyelonephritis

Approved in Japan as Levofloxacin for:

• Respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Dr. William Curry

Brigham and Women's Hospital

Chief Medical Officer

MD from Columbia University College of Physicians and Surgeons

Dr. Scott Schissel

Brigham and Women's Hospital

Chief Executive Officer since 2021

MD from Columbia University College of Physicians and Surgeons