BK Viremia
Conditions
Keywords
BK viremia, kidney transplantation, BK viremia in kidney transplant recipients
Brief 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.
Interventions
DRUGlevofloxacin
500 mg tablet, daily, 30 days
DRUGplacebo
no dose, tablet, daily, 30 days
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in BK Virus Copies at 3 Months | Baseline and 3 months | Percent change in BK virus copies/mL from Baseline to 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With >50% Reduction in BK Virus Copies | Baseline and 6 months | Number of patients with \>50% reduction in BK viral load at 6 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Levofloxacin Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days
levofloxacin: 500 mg tablet, daily, 30 days | 20 |
| Placebo placebo identical to levofloxacin drug daily for 30 days
placebo: no dose, tablet, daily, 30 days | 19 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Levofloxacin | Placebo | Total |
|---|---|---|---|
| Age, Continuous Age at time of consent | 56.22 years | 54.9 years | 55.36 years |
| Region of Enrollment United States | 20 participants | 19 participants | 39 participants |
| Sex: Female, Male Female | 2 Participants | 7 Participants | 9 Participants |
| Sex: Female, Male Male | 18 Participants | 12 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 1 / 19 |
| other Total, other adverse events | 2 / 20 | 0 / 19 |
| serious Total, serious adverse events | 1 / 20 | 1 / 19 |
Outcome results
Primary
Percent Change From Baseline in BK Virus Copies at 3 Months
Percent change in BK virus copies/mL from Baseline to 3 months
Time frame: Baseline and 3 months
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Levofloxacin | Percent Change From Baseline in BK Virus Copies at 3 Months | 70.3 Percent change of BK virus copies | Standard Deviation 42.5 |
| Placebo | Percent Change From Baseline in BK Virus Copies at 3 Months | 69.1 Percent change of BK virus copies | Standard Deviation 39.5 |
Secondary
Number of Patients With >50% Reduction in BK Virus Copies
Number of patients with \>50% reduction in BK viral load at 6 months
Time frame: Baseline and 6 months
Population: number of patients with \>50% reduction in BK viral load at 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levofloxacin | Number of Patients With >50% Reduction in BK Virus Copies | 15 participants |
| Placebo | Number of Patients With >50% Reduction in BK Virus Copies | 13 participants |