BK Virus InfectionPhase 4NCT01624948
Safety and Efficacy Study of Everolimus to Treat BK Virus Infection in Kidney Transplant Recipients
A Phase 4 study testing Everolimus and Mycophenolic acid dose reduction in people with BK Virus Infection, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study is examining the safety and efficacy of converting anti-rejection therapy from mycophenolic acid (MPA) to Zortress (everolimus) in renal transplant recipients with BK virus infection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- BK Virus Infection
- What is being tested?
- Everolimus and Mycophenolic acid dose reduction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Nov 2015
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female renal transplant recipients 18-75 years of age (primary or re-transplant)
- Recipients of cadaveric, living unrelated or living related donor kidney
- Baseline immunosuppression (IS) consisting of tacrolimus, MPA, and prednisone
- Patients with BK viruria ≥ 1 million copies/mL and/or viremia (> 500 copies/mL) found on routine BKV screening.
- Patients who have given written informed consent to participate in the study
Who cannot join
- Patients who are ABO incompatible transplants
- Patients with an abnormal liver profile such as Alanine Aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, or total bilirubin > 3x ULN at the time of randomization
- Patients with severe total hypercholesterolemia (> 350 mg/dL) or total hypertriglyceridemia (> 500 mg/dL). Patients on lipid lowering drugs with controlled hyperlipidemia are acceptable.
- Patients with a platelet count < 100,000/mm3 at randomization
- Patients with an ANC < 1,500/mm3 or WBC < 4.5mm3
- Patients with a known hypersensitivity to the study drug or to drugs of similar chemical classes.
Show all 16Show fewer
- Patients being treated with drugs (other than tacrolimus) that are potent inducers or inhibitors of cytochrome P4503A4
- Patients who have any surgical or medical condition, such as severe diarrhea, active peptic ulcer disease, or uncontrolled DM, which, in the opinion of the investigators, might significantly alter the absorption, distribution, metabolism and/or excretion of study medication.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine human chorionic gonadotrophin laboratory test
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method.
- Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.
- Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
- Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL and estradiol < 20 pg/mL] or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
- Patients with baseline urine protein excretion > 500mg/day
- Patients with Estimated Glomerular Filtration Rate (eGFR) < 40 ml/min
- Patients who have undergone desensitization
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Safety and Efficacy of Mycophenolic Acid Withdrawal With Conversion to Zortress (Everolimus) in Renal Transplant Recipients With BK Virus Infection
This study is examining the safety and efficacy of converting anti-rejection therapy from mycophenolic acid (MPA) to Zortress (everolimus) in renal transplant recipients with BK virus infection.
The study will also determine if immune monitoring tests can detect an association between BK virus infection and transplant rejection episodes, based on the specific BKV infection treatment regimen.
The investigators hypothesize that an anti-rejection regimen with Zortress (everolimus) and tacrolimus + prednisone will be superior to a standard regimen of reduced dose MPA and tacrolimus + prednisone in patients who have undergone renal transplantation and have active BKV infections.
Read the detailed description
This is a pilot study designed as a single center, randomized, open-label trial study comparing the safety and efficacy of MPA discontinuation with the addition of Zortress (everolimus) versus standard immunosuppression reduction in adult patients who have undergone a renal transplant and who have evidence of BKV infection. All kidney transplant recipients at University of California, San Francisco (UCSF) are screened for BKV in the urine and plasma at months 1, 3, 6, 9, and 12 post-transplantation. The presence of viruria > 1 million copies/mL and/or viremia prompts a 50% reduction in the MPA dose as well as monthly monitoring of BKV in the urine and plasma. Renal transplant patients found to have BK viruria > 1 million copies/mL and/or viremia > 500 copies/mL on any screening lab will be eligible for enrollment.
Before any study-related evaluations are performed, the patient must give written informed consent. Once consent is obtained, patients will be randomized in consecutive blocks of 10, such that there will be 5 patients allocated to each group for each block. Only the study coordinator will have access to the block sequences. Patients will be randomized to one of two groups: group 1 will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; group 2 will undergo a 50% dose reduction in MPA and continue with tacrolimus and prednisone.
The two groups will be as follows: All patients in group 1 will undergo discontinuation of MPA and will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL. Group 2 patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated. Tacrolimus trough levels are lower in the Zortress (everolimus) arm in order to minimize any potential nephrotoxicity with this drug combination as well as minimize the risk of over-immunosuppression.
In all patients, routine transplant monitoring labs will be performed monthly as part of standard of care including a measurement of blood urea nitrogen (BUN) and creatinine (Cr), complete blood count (CBC), tacrolimus trough levels, urine protein excretion and fasting lipids.
During the 3 month treatment period patients will be seen in clinic at baseline and months 1, 2, and 3 for follow-up. The assessment to address the primary objective will be performed at the end of the treatment period (Month 3). An interim analysis will be performed once 50% enrollment is reached.
In a sub-group of patients (30 patients total; 15 in group 1 and 15 in group 2) using our whole-blood assay measuring p70S6 kinase phosphorylation, the investigators will investigate the correlation between inhibition of p70S6 kinase phosphorylation with BKV replication. Finally, by measuring both p70S6 phosphorylation inhibition as well as expression of the nuclear factor of activated T cells (NFAT)-regulated genes Interleukin (IL)-2, interferon gamma and GM-CSF, the investigators will correlate rejection episodes in patients maintained on lower immunosuppression alone versus those on a Zortress (everolimus) -based regimen. As patients are assigned to their intervention group based on the randomization scheme they will be offered enrollment in this sub-group analysis. All patients will be sequentially enrolled in the sub-group analysis until the 30 subject goal is reached with 15 subjects per group.
- Conditions
- BK Virus Infection
- Being tested
- Everolimus, Mycophenolic acid dose reduction
- Keywords
- BK virus, Kidney Transplantation, Immunologic Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called Zortress
Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
Mycophenolic acid dose reductionDrug
Also called CellCept, Myfortic
Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone.
| Study group | Role | What they receive |
|---|---|---|
| Everolimus+Tacrolimus/Prednisone | Experimental | This arm (group 1) will undergo mycophenolic acid (MPA) discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL. Receives: Drug: Everolimus |
| Standard of care: 50% reduction of MPA | Active comparator | This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated. Receives: Drug: Mycophenolic acid dose reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of Reduction of BK Viruria and/or Clearance of BK Viremia
composite outcome of a 50% or greater reduction in BKV urine levels and/or complete clearance of BKV viremia by 3 months after randomization
Measured: 3 months post-randomization
Secondary outcomes (5)
Evaluation for the Development of BK Virus Nephropathy or Doubling of BK Viremia Levels
A doubling of BK viremia levels or the development of BKV nephropathy in subjects enrolled in the experimental study arm will prompt a conversion to standard care therapy. We will closely monitor BKV levels in the urine and blood and assess renal function monthly, as per our usual standard of care. Based on BKV results as well as renal function, as assessed by serum Cr, biopsies may be done for cause. Patients will have a final visit at month 4 to monitor for adverse events.
Measured: 3 months post-randomization
p70S6 Kinase Phosphorylation
Measured: 3 months post-randomization
Cholesterol
Measured: 3 months post-randomization
Proteinuria
Measured: 3 months post-randomization
Median Between the Calculated Mean Residual Expression of NFAT-regulated Genes
Measurement of the expression of three NFAT-regulated genes IL-2, interferon gamma, and GM-CSF, to predict a rejection episode.
The residual gene expression after Tacrolimus intake was calculated as T1.5/T0*100, where T0 is the adjusted number of transcripts at Tacrolimus pre-dose level and T1.5 is the number of transcripts 1.5 hours after drug intake. For all three genes the residual expression was averaged and presented as "MRE of NFAT-regulated genes."
Measured: 3 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2015
- Study completionNov 2015
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 (1)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 University of California, San FranciscoThe 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison Webber, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624948
- Sponsor's protocol ID
- CRAD001AUS184T
- Status last verified
- Jul 2016
- First submitted
- 15 Jun 2012
- Last updated
- 15 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wajih 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 39382091
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Mycophenolic Acid Withdrawal With Conversion to Zortress (Everolimus) in Renal Transplant Recipients With BK Virus Infection
- ClinicalTrials.gov ID
- NCT01624948
- Acronym / sponsor ID
- CRAD001AUS184T
- Conditions
- BK Virus Infection
- Keywords
- BK virus, Kidney Transplantation, Immunologic Monitoring
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 21 Jun 2012 (estimated)
- Results
- Posted 15 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is examining the safety and efficacy of converting anti-rejection therapy from mycophenolic acid (MPA) to Zortress (everolimus) in renal transplant recipients with BK virus infection.
The study will also determine if immune monitoring tests can detect an association between BK virus infection and transplant rejection episodes, based on the specific BKV infection treatment regimen.
The investigators hypothesize that an anti-rejection regimen with Zortress (everolimus) and tacrolimus + prednisone will be superior to a standard regimen of reduced dose MPA and tacrolimus + prednisone in patients who have undergone renal transplantation and have active BKV infections.
Detailed description
This is a pilot study designed as a single center, randomized, open-label trial study comparing the safety and efficacy of MPA discontinuation with the addition of Zortress (everolimus) versus standard immunosuppression reduction in adult patients who have undergone a renal transplant and who have evidence of BKV infection. All kidney transplant recipients at University of California, San Francisco (UCSF) are screened for BKV in the urine and plasma at months 1, 3, 6, 9, and 12 post-transplantation. The presence of viruria > 1 million copies/mL and/or viremia prompts a 50% reduction in the MPA dose as well as monthly monitoring of BKV in the urine and plasma. Renal transplant patients found to have BK viruria > 1 million copies/mL and/or viremia > 500 copies/mL on any screening lab will be eligible for enrollment.
Before any study-related evaluations are performed, the patient must give written informed consent. Once consent is obtained, patients will be randomized in consecutive blocks of 10, such that there will be 5 patients allocated to each group for each block. Only the study coordinator will have access to the block sequences. Patients will be randomized to one of two groups: group 1 will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; group 2 will undergo a 50% dose reduction in MPA and continue with tacrolimus and prednisone.
The two groups will be as follows: All patients in group 1 will undergo discontinuation of MPA and will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL. Group 2 patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated. Tacrolimus trough levels are lower in the Zortress (everolimus) arm in order to minimize any potential nephrotoxicity with this drug combination as well as minimize the risk of over-immunosuppression.
In all patients, routine transplant monitoring labs will be performed monthly as part of standard of care including a measurement of blood urea nitrogen (BUN) and creatinine (Cr), complete blood count (CBC), tacrolimus trough levels, urine protein excretion and fasting lipids.
During the 3 month treatment period patients will be seen in clinic at baseline and months 1, 2, and 3 for follow-up. The assessment to address the primary objective will be performed at the end of the treatment period (Month 3). An interim analysis will be performed once 50% enrollment is reached.
In a sub-group of patients (30 patients total; 15 in group 1 and 15 in group 2) using our whole-blood assay measuring p70S6 kinase phosphorylation, the investigators will investigate the correlation between inhibition of p70S6 kinase phosphorylation with BKV replication. Finally, by measuring both p70S6 phosphorylation inhibition as well as expression of the nuclear factor of activated T cells (NFAT)-regulated genes Interleukin (IL)-2, interferon gamma and GM-CSF, the investigators will correlate rejection episodes in patients maintained on lower immunosuppression alone versus those on a Zortress (everolimus) -based regimen. As patients are assigned to their intervention group based on the randomization scheme they will be offered enrollment in this sub-group analysis. All patients will be sequentially enrolled in the sub-group analysis until the 30 subject goal is reached with 15 subjects per group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Everolimus+Tacrolimus/Prednisone | Experimental | Drug: EverolimusThis arm (group 1) will undergo mycophenolic acid (MPA) discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL. |
| Standard of care: 50% reduction of MPA | Active comparator | Drug: Mycophenolic acid dose reductionThis arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female renal transplant recipients 18-75 years of age (primary or re-transplant)
- Recipients of cadaveric, living unrelated or living related donor kidney
- Baseline immunosuppression (IS) consisting of tacrolimus, MPA, and prednisone
- Patients with BK viruria ≥ 1 million copies/mL and/or viremia (> 500 copies/mL) found on routine BKV screening.
- Patients who have given written informed consent to participate in the study
Key exclusion criteria (16 listed)
- Patients who are ABO incompatible transplants
- Patients with an abnormal liver profile such as Alanine Aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, or total bilirubin > 3x ULN at the time of randomization
- Patients with severe total hypercholesterolemia (> 350 mg/dL) or total hypertriglyceridemia (> 500 mg/dL). Patients on lipid lowering drugs with controlled hyperlipidemia are acceptable.
- Patients with a platelet count < 100,000/mm3 at randomization
- Patients with an ANC < 1,500/mm3 or WBC < 4.5mm3
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 |
|---|---|---|
| EverolimusAlso: ZortressEverolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL. | Drug | Everolimus+Tacrolimus/Prednisone |
| Mycophenolic acid dose reductionAlso: CellCept, MyforticGroup 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone. | Drug | Standard of care: 50% reduction of MPA |
Primary outcome
Evidence of Reduction of BK Viruria and/or Clearance of BK Viremia
Time frame: 3 months post-randomization
composite outcome of a 50% or greater reduction in BKV urine levels and/or complete clearance of BKV viremia by 3 months after randomization
5 secondary outcomes
Evaluation for the Development of BK Virus Nephropathy or Doubling of BK Viremia Levels
Time frame: 3 months post-randomization
p70S6 Kinase Phosphorylation
Time frame: 3 months post-randomization
Cholesterol
Time frame: 3 months post-randomization
Proteinuria
Time frame: 3 months post-randomization
Median Between the Calculated Mean Residual Expression of NFAT-regulated Genes
Time frame: 3 months post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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A Trial to Evaluate the Safety, Tolerability and Efficacy of AIC263029 in Kidney Transplant Recipients With BKV Infection
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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.
Allison Webber, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Everolimus and Mycophenolic acid dose reduction in people with BK Virus Infection, run by University of California, San Francisco 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 5 inclusion and 16 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 15 Aug 2016. 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.
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 15 Aug 2016). 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?
Evidence of Reduction of BK Viruria and/or Clearance of BK Viremia (time frame: 3 months post-randomization). 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 NCT01624948, which also lists 1 linked publication.
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 15 Aug 2016.