BK Virus InfectionNCT02758288
BK Virus Post-Kidney Transplant: New Practice Versus Traditional Approach
An observational study of BK Virus Infection and BK Virus Nephropathy, run by Loma Linda University at 1 site in United States.
Trial summary
The investigator's aim in this study is to evaluate the impact of a new standard of care protocol for the treatment of BK viremia and nephropathy (BKVAN), which includes switching from Tacrolimus to equivalent dose of Cyclosporine in patients who have been diagnosed with BK viremia or BKVAN based on their viral load… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BK Virus Infection, BK Virus Nephropathy
- What is being tested?
- New Protocol - BK viremia or BK virus nephropathy and Standard Protocol - BK viremia or BK virus nephropathy
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Adult kidney recipients who are determined to have BK viremia post-transplant
Who may be able to join
- Age ≥ 18 years
- Recipient of kidney or combined kidney and pancreas
- BK viremia confirmed with blood PCR test with viral load over 500
- BK virus nephropathy confirmed by kidney biopsy
Who cannot join
- Recipient of combined organ transplant except kidney and pancreases
- Patient age < 18 years
- If patient does not consent for kidney biopsy
- Currently on treatment for acute rejection
- Patients with HIV, Hep C or Hep B infection
- Patients who are on other immunosuppression beside our standard regimen which includes Prograf, cellcept / Myfortic and prednisone
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center
Loma Linda, California, 92354
About this study
Official title: BK Viremia and BK Virus Nephropathy Post Kidney Transplant Comparison of New Practices With Traditional Approach: A Combined Retrospective Chart Review and Prospective Observational Study
The investigator's aim in this study is to evaluate the impact of a new standard of care protocol for the treatment of BK viremia and nephropathy (BKVAN), which includes switching from Tacrolimus to equivalent dose of Cyclosporine in patients who have been diagnosed with BK viremia or BKVAN based on their viral load, overall graft function (estimated glomerular filtration rate), acute rejection, and rate of graft loss due to rejection or BKVAN.
Read the detailed description
This study will be a combined retrospective chart review and prospective observational study. This will be a single center project that will take place at Loma Linda University Transplant Institute. All adult kidney recipients who are determined to have BK viremia with a BK PCR viral load over 500 copy post-transplant and meet the inclusion criteria but no exclusion criteria will be enrolled and observed per study protocol.
All kidney transplant recipients are routinely assessed for BK virus nephropathy and viremia post transplant as part of their standard care. Patients with BK viremia or BK virus nephropathy will have adjustments in their immunosuppressive medication based on current guidelines and recommendations which include reduction in immunosuppression, treatment with medications with antiviral activity (Cidofovir, Ciprofloxacin, Leflunomide, IVIG) or switching from a Tacrolimus (Prograf)-based regimen to a Cyclosporine-based regimen. Retrospectively, the investigator will collect data on patients who have been diagnosed with BK viremia or BK virus nephropathy and have had such a management in past 66 months (from 1/1/2010 till 06/30/2015). Prospectively, the investigator will enroll and collect data on patients who will be treated for BK viremia or BK virus nephropathy.
As standard of care, all kidney transplant recipients will be seen routinely on weekly-biweekly basis in post-transplant clinic for up to 3 months then every 3 months for up to a year and yearly thereafter. All kidney transplant recipients will be monitored for BK viremia by having blood PCR tested on a monthly basis at 1, 2, 3, 6, and 12 months after transplant. Also, all patients post-kidney transplant will be tested for BK viremia if there is an acute rise in their creatinine.
- Conditions
- BK Virus Infection, BK Virus Nephropathy
- Being tested
- New Protocol - BK viremia or BK virus nephropathy, Standard Protocol - BK viremia or BK virus nephropathy
- Keywords
- Kidney transplant, BK Viremia, BK Nephropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Protocol - BK viremia or BK virus nephropathyOther
Data collected prospectively that will follow new clinical practice guidelines that were developed by Loma Linda Nephrology group with collaboration with Transplant surgeons to improve care of patients complicated with BK viremia or BK virus nephropathy.
Standard Protocol - BK viremia or BK virus nephropathyOther
Data collected retrospectively that followed standard clinical practice guidelines that were developed by Loma Linda Nephrology group with collaboration with Transplant surgeons to improve care of patients complicated with BK viremia or BK virus nephropathy.
| Study group | Role | What they receive |
|---|---|---|
| New Protocol to treat BK viremia or BKVAN | Adult kidney recipients who are determined to have BK viremia with a BK PCR viral load over 500 copy post-transplant treated with a new treatment protocol, prospective data collection approach Receives: Other: New Protocol - BK viremia or BK virus nephropathy | |
| Standard Protocol to treat BK viremia or BKVAN | Adult kidney recipients who are determined to have BK viremia with a BK PCR viral load over 500 copy post-transplant treated with a traditional standard of care protocol, retrospective data collection approach Receives: Other: Standard Protocol - BK viremia or BK virus nephropathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney function to compare effectiveness of a new care protocol for the treatment of BK viremia (BK PCR viral load over 500 copy) and BKVAN (confirmed by kidney biopsy) with a similar cohort treated with traditional methods.
Measured: 12 months
Secondary outcomes (4)
Rate of BK nephropathy in both treatment groups confirmed by kidney biopsy
Measured: 24 months
Rate of acute cellular or humoral rejection in both treatment groups confirmed by kidney biopsy
Measured: 24 months
Rate of graft loss in both group as determined by elevated creatinine level and kidney biopsy
Measured: 24 months
Estimated glomerular filtration rate (eGFR) at start of the study (0) , 3, 6, 12 and 24 months between two groups
Measured: 3, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startSep 2015
- Primary completionJul 2021 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for BK Virus InfectionStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Abdipour, MD, Loma Linda University
- Investigators
- Amir Abdipour, MD, Principal investigator, Loma Linda University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758288
- Sponsor's protocol ID
- 5150278
- Status last verified
- Oct 2020
- First submitted
- 2 Mar 2016
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Tonelli M, Wiebe N, Knoll G, Bello A, Browne S, Jadhav D, Klarenbach S, Gill J. Systematic review: kidney transplantation compared with dialysis in clinically relevant outcomes. Am J Transplant. 2011 Oct;11(10):2093-109. doi: 10.1111/j.1600-6143.2011.03686.x. Epub 2011 Aug 30.
PubMed 21883901Port FK, Wolfe RA, Mauger EA, Berling DP, Jiang K. Comparison of survival probabilities for dialysis patients vs cadaveric renal transplant recipients. JAMA. 1993 Sep 15;270(11):1339-43.
PubMed 8360969Schnuelle P, Lorenz D, Trede M, Van Der Woude FJ. Impact of renal cadaveric transplantation on survival in end-stage renal failure: evidence for reduced mortality risk compared with hemodialysis during long-term follow-up. J Am Soc Nephrol. 1998 Nov;9(11):2135-41. doi: 10.1681/ASN.V9112135.
PubMed 9808102Padgett BL, Walker DL. Prevalence of antibodies in human sera against JC virus, an isolate from a case of progressive multifocal leukoencephalopathy. J Infect Dis. 1973 Apr;127(4):467-70. doi: 10.1093/infdis/127.4.467. No abstract available.
PubMed 4571704Bressollette-Bodin C, Coste-Burel M, Hourmant M, Sebille V, Andre-Garnier E, Imbert-Marcille BM. A prospective longitudinal study of BK virus infection in 104 renal transplant recipients. Am J Transplant. 2005 Aug;5(8):1926-33. doi: 10.1111/j.1600-6143.2005.00934.x.
PubMed 15996241Ginevri F, Azzi A, Hirsch HH, Basso S, Fontana I, Cioni M, Bodaghi S, Salotti V, Rinieri A, Botti G, Perfumo F, Locatelli F, Comoli P. Prospective monitoring of polyomavirus BK replication and impact of pre-emptive intervention in pediatric kidney recipients. Am J Transplant. 2007 Dec;7(12):2727-35. doi: 10.1111/j.1600-6143.2007.01984.x. Epub 2007 Oct 1.
PubMed 17908275Brennan DC, Agha I, Bohl DL, Schnitzler MA, Hardinger KL, Lockwood M, Torrence S, Schuessler R, Roby T, Gaudreault-Keener M, Storch GA. Incidence of BK with tacrolimus versus cyclosporine and impact of preemptive immunosuppression reduction. Am J Transplant. 2005 Mar;5(3):582-94. doi: 10.1111/j.1600-6143.2005.00742.x.
PubMed 15707414Kadambi PV, Josephson MA, Williams J, Corey L, Jerome KR, Meehan SM, Limaye AP. Treatment of refractory BK virus-associated nephropathy with cidofovir. Am J Transplant. 2003 Feb;3(2):186-91. doi: 10.1034/j.1600-6143.2003.30202.x.
PubMed 12614296Moscarelli L, Caroti L, Antognoli G, Zanazzi M, Di Maria L, Carta P, Minetti E. Everolimus leads to a lower risk of BKV viremia than mycophenolic acid in de novo renal transplantation patients: a single-center experience. Clin Transplant. 2013 Jul-Aug;27(4):546-54. doi: 10.1111/ctr.12151. Epub 2013 Jun 13.
PubMed 23758330Araya CE, Garin EH, Neiberger RE, Dharnidharka VR. Leflunomide therapy for BK virus allograft nephropathy in pediatric and young adult kidney transplant recipients. Pediatr Transplant. 2010 Feb;14(1):145-50. doi: 10.1111/j.1399-3046.2009.01183.x. Epub 2009 Mar 31.
PubMed 19344337Williams JW, Javaid B, Kadambi PV, Gillen D, Harland R, Thistlewaite JR, Garfinkel M, Foster P, Atwood W, Millis JM, Meehan SM, Josephson MA. Leflunomide for polyomavirus type BK nephropathy. N Engl J Med. 2005 Mar 17;352(11):1157-8. doi: 10.1056/NEJM200503173521125. No abstract available.
PubMed 15784677Leung 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 16206122Hirsch HH, Vincenti F, Friman S, Tuncer M, Citterio F, Wiecek A, Scheuermann EH, Klinger M, Russ G, Pescovitz MD, Prestele H. Polyomavirus BK replication in de novo kidney transplant patients receiving tacrolimus or cyclosporine: a prospective, randomized, multicenter study. Am J Transplant. 2013 Jan;13(1):136-45. doi: 10.1111/j.1600-6143.2012.04320.x. Epub 2012 Nov 8.
PubMed 23137180Renner FC, Dietrich H, Bulut N, Celik D, Freitag E, Gaertner N, Karoui S, Mark J, Raatz C, Weimer R, Feustel A. The risk of polyomavirus-associated graft nephropathy is increased by a combined suppression of CD8 and CD4 cell-dependent immune effects. Transplant Proc. 2013 May;45(4):1608-10. doi: 10.1016/j.transproceed.2013.01.026.
PubMed 23726630
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BK Viremia and BK Virus Nephropathy Post Kidney Transplant Comparison of New Practices With Traditional Approach: A Combined Retrospective Chart Review and Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02758288
- Acronym / sponsor ID
- 5150278
- Conditions
- BK Virus Infection, BK Virus Nephropathy
- Keywords
- Kidney transplant, BK Viremia, BK Nephropathy
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 2 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigator's aim in this study is to evaluate the impact of a new standard of care protocol for the treatment of BK viremia and nephropathy (BKVAN), which includes switching from Tacrolimus to equivalent dose of Cyclosporine in patients who have been diagnosed with BK viremia or BKVAN based on their viral load, overall graft function (estimated glomerular filtration rate), acute rejection, and rate of graft loss due to rejection or BKVAN.
Detailed description
This study will be a combined retrospective chart review and prospective observational study. This will be a single center project that will take place at Loma Linda University Transplant Institute. All adult kidney recipients who are determined to have BK viremia with a BK PCR viral load over 500 copy post-transplant and meet the inclusion criteria but no exclusion criteria will be enrolled and observed per study protocol.
All kidney transplant recipients are routinely assessed for BK virus nephropathy and viremia post transplant as part of their standard care. Patients with BK viremia or BK virus nephropathy will have adjustments in their immunosuppressive medication based on current guidelines and recommendations which include reduction in immunosuppression, treatment with medications with antiviral activity (Cidofovir, Ciprofloxacin, Leflunomide, IVIG) or switching from a Tacrolimus (Prograf)-based regimen to a Cyclosporine-based regimen. Retrospectively, the investigator will collect data on patients who have been diagnosed with BK viremia or BK virus nephropathy and have had such a management in past 66 months (from 1/1/2010 till 06/30/2015). Prospectively, the investigator will enroll and collect data on patients who will be treated for BK viremia or BK virus nephropathy.
As standard of care, all kidney transplant recipients will be seen routinely on weekly-biweekly basis in post-transplant clinic for up to 3 months then every 3 months for up to a year and yearly thereafter. All kidney transplant recipients will be monitored for BK viremia by having blood PCR tested on a monthly basis at 1, 2, 3, 6, and 12 months after transplant. Also, all patients post-kidney transplant will be tested for BK viremia if there is an acute rise in their creatinine.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Protocol to treat BK viremia or BKVAN | – | Other: New Protocol - BK viremia or BK virus nephropathyAdult kidney recipients who are determined to have BK viremia with a BK PCR viral load over 500 copy post-transplant treated with a new treatment protocol, prospective data collection approach |
| Standard Protocol to treat BK viremia or BKVAN | – | Other: Standard Protocol - BK viremia or BK virus nephropathyAdult kidney recipients who are determined to have BK viremia with a BK PCR viral load over 500 copy post-transplant treated with a traditional standard of care protocol, retrospective data collection approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult kidney recipients who are determined to have BK viremia post-transplant
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Recipient of kidney or combined kidney and pancreas
Key exclusion criteria (6 listed)
- Recipient of combined organ transplant except kidney and pancreases
- Patient age < 18 years
- If patient does not consent for kidney biopsy
- Currently on treatment for acute rejection
- Patients with HIV, Hep C or Hep B infection
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 |
|---|---|---|
| New Protocol - BK viremia or BK virus nephropathyData collected prospectively that will follow new clinical practice guidelines that were developed by Loma Linda Nephrology group with collaboration with Transplant surgeons to improve care of patients complicated with BK viremia or BK virus nephropathy. | Other | New Protocol to treat BK viremia or BKVAN |
| Standard Protocol - BK viremia or BK virus nephropathyData collected retrospectively that followed standard clinical practice guidelines that were developed by Loma Linda Nephrology group with collaboration with Transplant surgeons to improve care of patients complicated with BK viremia or BK virus nephropathy. | Other | Standard Protocol to treat BK viremia or BKVAN |
Primary outcome
Kidney function to compare effectiveness of a new care protocol for the treatment of BK viremia (BK PCR viral load over 500 copy) and BKVAN (confirmed by kidney biopsy) with a similar cohort treated with traditional methods.
Time frame: 12 months
4 secondary outcomes
Rate of BK nephropathy in both treatment groups confirmed by kidney biopsy
Time frame: 24 months
Rate of acute cellular or humoral rejection in both treatment groups confirmed by kidney biopsy
Time frame: 24 months
Rate of graft loss in both group as determined by elevated creatinine level and kidney biopsy
Time frame: 24 months
Estimated glomerular filtration rate (eGFR) at start of the study (0) , 3, 6, 12 and 24 months between two groups
Time frame: 3, 6, 12, 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Background: PubMed 21883901Tonelli M, Wiebe N, Knoll G, Bello A, Browne S, Jadhav D, Klarenbach S, Gill J. Systematic review: kidney transplantation compared with dialysis in clinically relevant outcomes. Am J Transplant. 2011 Oct;11(10):2093-109. doi: 10.1111/j.1600-6143.2011.03686.x. Epub 2011 Aug 30.
- Background: PubMed 8360969Port FK, Wolfe RA, Mauger EA, Berling DP, Jiang K. Comparison of survival probabilities for dialysis patients vs cadaveric renal transplant recipients. JAMA. 1993 Sep 15;270(11):1339-43.
- Background: PubMed 9808102Schnuelle P, Lorenz D, Trede M, Van Der Woude FJ. Impact of renal cadaveric transplantation on survival in end-stage renal failure: evidence for reduced mortality risk compared with hemodialysis during long-term follow-up. J Am Soc Nephrol. 1998 Nov;9(11):2135-41. doi: 10.1681/ASN.V9112135.
- Background: PubMed 4571704Padgett BL, Walker DL. Prevalence of antibodies in human sera against JC virus, an isolate from a case of progressive multifocal leukoencephalopathy. J Infect Dis. 1973 Apr;127(4):467-70. doi: 10.1093/infdis/127.4.467. No abstract available.
- Background: PubMed 15996241Bressollette-Bodin C, Coste-Burel M, Hourmant M, Sebille V, Andre-Garnier E, Imbert-Marcille BM. A prospective longitudinal study of BK virus infection in 104 renal transplant recipients. Am J Transplant. 2005 Aug;5(8):1926-33. doi: 10.1111/j.1600-6143.2005.00934.x.
- Background: PubMed 17908275Ginevri F, Azzi A, Hirsch HH, Basso S, Fontana I, Cioni M, Bodaghi S, Salotti V, Rinieri A, Botti G, Perfumo F, Locatelli F, Comoli P. Prospective monitoring of polyomavirus BK replication and impact of pre-emptive intervention in pediatric kidney recipients. Am J Transplant. 2007 Dec;7(12):2727-35. doi: 10.1111/j.1600-6143.2007.01984.x. Epub 2007 Oct 1.
- Background: PubMed 15707414Brennan DC, Agha I, Bohl DL, Schnitzler MA, Hardinger KL, Lockwood M, Torrence S, Schuessler R, Roby T, Gaudreault-Keener M, Storch GA. Incidence of BK with tacrolimus versus cyclosporine and impact of preemptive immunosuppression reduction. Am J Transplant. 2005 Mar;5(3):582-94. doi: 10.1111/j.1600-6143.2005.00742.x.
- Background: PubMed 12614296Kadambi PV, Josephson MA, Williams J, Corey L, Jerome KR, Meehan SM, Limaye AP. Treatment of refractory BK virus-associated nephropathy with cidofovir. Am J Transplant. 2003 Feb;3(2):186-91. doi: 10.1034/j.1600-6143.2003.30202.x.
- Background: PubMed 23758330Moscarelli L, Caroti L, Antognoli G, Zanazzi M, Di Maria L, Carta P, Minetti E. Everolimus leads to a lower risk of BKV viremia than mycophenolic acid in de novo renal transplantation patients: a single-center experience. Clin Transplant. 2013 Jul-Aug;27(4):546-54. doi: 10.1111/ctr.12151. Epub 2013 Jun 13.
- Background: PubMed 19344337Araya CE, Garin EH, Neiberger RE, Dharnidharka VR. Leflunomide therapy for BK virus allograft nephropathy in pediatric and young adult kidney transplant recipients. Pediatr Transplant. 2010 Feb;14(1):145-50. doi: 10.1111/j.1399-3046.2009.01183.x. Epub 2009 Mar 31.
- Background: PubMed 15784677Williams JW, Javaid B, Kadambi PV, Gillen D, Harland R, Thistlewaite JR, Garfinkel M, Foster P, Atwood W, Millis JM, Meehan SM, Josephson MA. Leflunomide for polyomavirus type BK nephropathy. N Engl J Med. 2005 Mar 17;352(11):1157-8. doi: 10.1056/NEJM200503173521125. No abstract available.
- 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.
- Individual participant dataSharing planned: No
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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.
Amir Abdipour, MD principal investigator
Loma Linda University Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BK Virus Infection and BK Virus Nephropathy, run by Loma Linda University at 1 site 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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Kidney function to compare effectiveness of a new care protocol for the treatment of BK viremia (BK PCR viral load over 500 copy) and BKVAN (confirmed by kidney biopsy) with a similar cohort treated with traditional methods. (time frame: 12 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 NCT02758288, which also lists 47 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 5 Oct 2020; AzTrials last refreshed its copy on 6 Nov 2026.