BK ViremiaPhase 4NCT01034176
BK Treatment Study
A Phase 4 study testing levofloxacin in people with BK Viremia, run by Brigham and Women's Hospital at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BK Viremia
- What is being tested?
- levofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 8 sitesUnited States
- Study dates
- Feb 2009to Oct 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Living and cadaveric kidney transplant recipients over the age of 18 years with BK viremia
Who cannot join
- 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
Show all 9Show fewer
- Patients with recurrent hypoglycemic episodes
- Patients with history of myasthenia gravis
- Patients taking Thioridazine
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Lahey Clinic Medical Center
Burlington, Massachusetts, 01805
Fletcher Allen Health Care/University of Vermont
Burlington, Vermont, 05401
University of Wisconsin Hospital
Madison, Wisconsin, 53792
Montefiore Medical Center
The Bronx, New York, 10467
UMASS Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: Effect of Fluoroquinolones on BK Viremia in the Renal Transplant Recipient, A Multi-Center 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.
- Conditions
- BK Viremia
- Being tested
- levofloxacin, placebo
- Keywords
- BK viremia, kidney transplantation, BK viremia in kidney transplant recipients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levofloxacinDrug
Also called Levaquin
500 mg tablet, daily, 30 days
placeboDrug
no dose, tablet, daily, 30 days
| Study group | Role | What they receive |
|---|---|---|
| Levofloxacin | Active comparator | Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days Receives: Drug: levofloxacin |
| placebo | Placebo comparator | placebo identical to levofloxacin drug daily for 30 days Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in BK Virus Copies at 3 Months
Percent change in BK virus copies/mL from Baseline to 3 months
Measured: Baseline and 3 months
Secondary outcomes (1)
Number of Patients With >50% Reduction in BK Virus Copies
Number of patients with >50% reduction in BK viral load at 6 months
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BK ViremiaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil K. Chandraker, MD, Brigham and Women's Hospital
- Investigators
- Anil Chandraker, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034176
- Sponsor's protocol ID
- 2009p000020
- Status last verified
- Mar 2017
- First submitted
- 16 Dec 2009
- Last updated
- 24 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Leung AY, Chan MT, Yuen KY, Cheng VC, Chan KH, Wong CL, Liang R, Lie AK, Kwong YL. Ciprofloxacin decreased polyoma BK virus load in patients who underwent allogeneic hematopoietic stem cell transplantation. Clin Infect Dis. 2005 Feb 15;40(4):528-37. doi: 10.1086/427291. Epub 2005 Jan 21.
PubMed 15712075Randhawa PS. Anti-BK virus activity of ciprofloxacin and related antibiotics. Clin Infect Dis. 2005 Nov 1;41(9):1366-7; author reply 1367. doi: 10.1086/497080. No abstract available.
PubMed 16206122Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.
PubMed 39382091Lee BT, Gabardi S, Grafals M, Hofmann RM, Akalin E, Aljanabi A, Mandelbrot DA, Adey DB, Heher E, Fan PY, Conte S, Dyer-Ward C, Chandraker A. Efficacy of levofloxacin in the treatment of BK viremia: a multicenter, double-blinded, randomized, placebo-controlled trial. Clin J Am Soc Nephrol. 2014 Mar;9(3):583-9. doi: 10.2215/CJN.04230413. Epub 2014 Jan 30.
PubMed 24482066
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fluoroquinolones on BK Viremia in the Renal Transplant Recipient, A Multi-Center Study
- ClinicalTrials.gov ID
- NCT01034176
- Acronym / sponsor ID
- 2009p000020
- Conditions
- BK Viremia
- Keywords
- BK viremia, kidney transplantation, BK viremia in kidney transplant recipients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 17 Dec 2009 (estimated)
- Results
- Posted 6 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levofloxacin | Active comparator | Drug: levofloxacinLevofloxacin 500 mg every day (dose adjusted for renal function) for 30 days |
| placebo | Placebo comparator | Drug: placeboplacebo identical to levofloxacin drug daily for 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Living and cadaveric kidney transplant recipients over the age of 18 years with BK viremia
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levofloxacinAlso: Levaquin500 mg tablet, daily, 30 days | Drug | Levofloxacin |
| placebono dose, tablet, daily, 30 days | Drug | placebo |
Primary outcome
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
1 secondary outcome
Number of Patients With >50% Reduction in BK Virus Copies
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15712075Leung AY, Chan MT, Yuen KY, Cheng VC, Chan KH, Wong CL, Liang R, Lie AK, Kwong YL. Ciprofloxacin decreased polyoma BK virus load in patients who underwent allogeneic hematopoietic stem cell transplantation. Clin Infect Dis. 2005 Feb 15;40(4):528-37. doi: 10.1086/427291. Epub 2005 Jan 21.
- Background: PubMed 16206122Randhawa PS. Anti-BK virus activity of ciprofloxacin and related antibiotics. Clin Infect Dis. 2005 Nov 1;41(9):1366-7; author reply 1367. doi: 10.1086/497080. No abstract available.
- Derived from this study: PubMed 39382091Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.
- Derived from this study: PubMed 24482066Lee BT, Gabardi S, Grafals M, Hofmann RM, Akalin E, Aljanabi A, Mandelbrot DA, Adey DB, Heher E, Fan PY, Conte S, Dyer-Ward C, Chandraker A. Efficacy of levofloxacin in the treatment of BK viremia: a multicenter, double-blinded, randomized, placebo-controlled trial. Clin J Am Soc Nephrol. 2014 Mar;9(3):583-9. doi: 10.2215/CJN.04230413. Epub 2014 Jan 30.
Related trials for BK Viremia
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BK Virus Infection, BKV Infection
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
RecruitingPhase 3
A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients
BK Viremia, Kidney Transplant Infection
RecruitingObservational study
Study of the Serotype and Genotype of BK Virus in Kidney Transplant Recipients and Their Donors to Identify Individuals at Risk of Nephropathy
Nephropathy, Opportunistic Viral Infection
Enrolling by invitationObservational study
Prevalence of BK Viremia in Simultaneous Liver-Kidney Transplant
Polyomavirus Infections, BK Viremia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anil Chandraker, MD principal investigator
Brigham and Women's Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levofloxacin in people with BK Viremia, run by Brigham and Women's Hospital at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in BK Virus Copies at 3 Months (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01034176, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.