Trial Outcomes & Findings for BK Treatment Study (NCT NCT01034176)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

43 participants

Primary outcome timeframe

Baseline and 3 months

Results posted on

2017-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	Levofloxacin Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days levofloxacin: 500 mg tablet, daily, 30 days	Placebo placebo identical to levofloxacin drug daily for 30 days placebo: no dose, tablet, daily, 30 days
Overall Study STARTED	22	21
Overall Study COMPLETED	20	19
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Levofloxacin Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days levofloxacin: 500 mg tablet, daily, 30 days	Placebo placebo identical to levofloxacin drug daily for 30 days placebo: no dose, tablet, daily, 30 days
Overall Study Physician Decision	2	0
Overall Study Withdrawal by Subject	0	1
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

BK Treatment Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levofloxacin n=20 Participants Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days levofloxacin: 500 mg tablet, daily, 30 days	Placebo n=19 Participants placebo identical to levofloxacin drug daily for 30 days placebo: no dose, tablet, daily, 30 days	Total n=39 Participants Total of all reporting groups
Age, Continuous Age at time of consent	56.22 years n=99 Participants	54.9 years n=107 Participants	55.36 years n=206 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	7 Participants n=107 Participants	9 Participants n=206 Participants
Sex: Female, Male Male	18 Participants n=99 Participants	12 Participants n=107 Participants	30 Participants n=206 Participants
Region of Enrollment United States	20 participants n=99 Participants	19 participants n=107 Participants	39 participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months

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

Outcome measures

Outcome measures
Measure	Levofloxacin n=20 Participants Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days levofloxacin: 500 mg tablet, daily, 30 days	Placebo n=19 Participants placebo identical to levofloxacin drug daily for 30 days placebo: no dose, tablet, daily, 30 days
Percent Change From Baseline in BK Virus Copies at 3 Months	70.3 Percent change of BK virus copies Standard Deviation 42.5	69.1 Percent change of BK virus copies Standard Deviation 39.5

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: number of patients with \>50% reduction in BK viral load at 6 months

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

Outcome measures

Outcome measures
Measure	Levofloxacin n=20 Participants Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days levofloxacin: 500 mg tablet, daily, 30 days	Placebo n=19 Participants placebo identical to levofloxacin drug daily for 30 days placebo: no dose, tablet, daily, 30 days
Number of Patients With >50% Reduction in BK Virus Copies	15 participants	13 participants

Adverse Events

Levofloxacin

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Levofloxacin n=20 participants at risk Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days levofloxacin: 500 mg tablet, daily, 30 days	Placebo n=19 participants at risk placebo identical to levofloxacin drug daily for 30 days placebo: no dose, tablet, daily, 30 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm, malignant	5.0% 1/20	0.00% 0/19
Psychiatric disorders suicidal ideation	0.00% 0/20	5.3% 1/19

Other adverse events

Other adverse events
Measure	Levofloxacin n=20 participants at risk Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days levofloxacin: 500 mg tablet, daily, 30 days	Placebo n=19 participants at risk placebo identical to levofloxacin drug daily for 30 days placebo: no dose, tablet, daily, 30 days
Musculoskeletal and connective tissue disorders achilles tendon strain/injury	10.0% 2/20	0.00% 0/19

Additional Information

Dr. Anil Chandraker

Brigham and Women's Hospital

Phone: 617-525-8203

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place