Renal Transplant InfectionPhase 2NCT03762473
Conversion to Envarsus Post Kidney Transplant Protects Against BK Infection
A Phase 2 study testing Study Group in people with Renal Transplant Infection, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to assess if the use of Envarsus in place of Tacrolimus-immediate release (IR) in rapid metabolizers post kidney transplant will reduce incidence of BK infection. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Renal Transplant Infection
- What is being tested?
- Study Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2019to 16 Mar 2022
- Phase
- Phase 2
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years of age at the time of study entry
- Recipient of a deceased or living donor kidney transplantation
- Maintenance immunosuppression consisting of tacrolimus/ mycophenolate mofetil (MMF)/mycophenolic acid (MPA) (≥1000 mg/720 mg daily) ± prednisone (≤10 mg/day)
- Patient is less than or at 8 weeks post transplant with a negative serum BK Virus screen at 3-4 weeks post transplant
- Patient has a tacrolimus drug dose/concentration of > 1 with therapeutic tacrolimus levels.
- Women of childbearing potential defined as all women physiologically capable of becoming pregnant, must have reviewed Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) and have a negative pregnancy test upon study entry.
- Female (and male) subjects with reproductive potential must agree to use a highly effective method of birth control for the duration of the study. Please note that according to the US product information for MMF/MPA, two reliable forms of contraception must be used simultaneously unless female sterilization, male sterilization, post-menopausal status or total abstinence is the chosen method.
Who cannot join
- Inability or unwillingness of a patient to give written informed consent or comply with study protocol
- History of graft loss from acute rejection within 1 year after any previous kidney transplant
- History of previous liver, heart, pancreas, or lung transplant
- History of cellular rejection of current allograft prior to enrollment.
- Serum BK virus ≥500 copies/ml by polymerase chain reaction (PCR) at the time of study entry
- Female subjects who are pregnant or breast feeding
Show all 10Show fewer
- Participation in any other studies with investigational drugs or regimens in the preceding year from the time of study entry
- Any condition or prior treatment which, in the opinion of the investigator, precludes study participation
- Patients requiring the use of azathioprine or a class of drugs that inhibit the mammalian target of rapamycin (mTOR inhibitors)
- Patients with active peptic ulcer disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Conversion From Tacrolimus to Envarsus in Rapid Metabolizers Post Kidney Transplant Protects Against BK Infection
The purpose of this study is to assess if the use of Envarsus in place of Tacrolimus-immediate release (IR) in rapid metabolizers post kidney transplant will reduce incidence of BK infection. Efficacy evaluations will include measurement of urine and serum BK values at specified time points and review of any biopsy for BK virus nephropathy. Incidence of rejection, graft failure, and graft dysfunction will also be measured at specified time points.
Read the detailed description
This will be a single center prospective case control study. The investigators expect 40% of patients will develop BK viruria, 20% BK viremia, 5% BK viral nephropathy (BKVN). Patients will be managed using standard of care for the investigator's center (thymoglobulin induction, tacrolimus/mycophenolate/prednisone). Target tacrolimus level is 8-12 ng/mL for the first 6 months post transplant and 6-9 ng/mL thereafter. BK urine/serum is monitored at 1, 3, 6, 9, 2 months post transplant. A population of 100 patients is calculated to show significant difference for p value < 0.05.
Population:
Study Group: Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at post-transplant month 1, who have a tacrolimus concentration/dose of < 1 and a steady state therapeutic level will be eligible. Patients who consent will be converted to Envarsus at 20% reduction in tacrolimus dose.
Control Group: Post transplant patients (kidney transplant alone performed between 10-2016 and time of enrollment) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at post-transplant month 1 and tacrolimus concentration/dose of < 1 at post-transplant month 1, and BK data available for months 2, 3, 6, 9,12 post transplant.
- Conditions
- Renal Transplant Infection
- Being tested
- Study Group, Control Group
- Keywords
- Envarsus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study GroupDrug
Also called tacrolimus extended-release tablets
Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.
Control GroupDrug
Also called Tacrolimus
Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of < 1 at month 1, and BK data available and month 2,3, 6,9,12.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of < 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose. Receives: Drug: Study Group |
| Control Group | Active comparator | Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of < 1 at month 1, and BK data available and month 2,3, 6,9,12. Receives: Drug: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Will Experience Less BK Infection Episodes Based on Viruria Results.
The evidence of BK virus infection will be measured by viruria >500 copies.
Measured: From baseline to 30 days
Participants Will Experience Less BK Infection Episodes Based on Viremia Results.
The evidence of BK virus infection will be measured by viremia >500 copies.
Measured: From baseline to 30 days
Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.
The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).
Measured: From baseline to 30 days
Participants Will Experience Less BK Infection Episodes Based on Viruria Results.
The evidence of BK virus infection will be measured by viruria >500 copies.
Measured: From baseline to 120 days
Participants Will Experience Less BK Infection Episodes Based on Viremia Results.
The evidence of BK virus infection will be measured by viremia >500 copies.
Measured: From baseline to 120 days
Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.
The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).
Measured: From baseline to 120 days
Participants Will Experience Less BK Infection Episodes Based on Viruria Results.
The evidence of BK virus infection will be measured by viruria >500 copies.
Measured: From baseline to 210 days
Participants Will Experience Less BK Infection Episodes Based on Viremia Results.
The evidence of BK virus infection will be measured by viremia >500 copies.
Measured: From baseline to 210 days
Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.
The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).
Measured: From baseline to 210 days
Number of Participants With Viruria >500 Copies
Participants will experience less BK infection episodes based on viruria reported with >500 copies.
Measured: at 300 days
Participants Will Experience Less BK Infection Episodes Based on Viremia Results.
The evidence of BK virus infection will be measured by viremia >500 copies.
Measured: at 300 days
Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.
The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).
Measured: at 300 days
Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.
Safety will be assessed for all Grade 3 or higher infection
Measured: From baseline to 30 days
Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.
Safety will be assessed for all Grade 3 or higher infection
Measured: From baseline to 120 days
Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.
Safety will be assessed for all Grade 3 or higher infection
Measured: From baseline to 210 days
Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.
Safety will be assessed for all Grade 3 or higher infection
Measured: at 300 days
Secondary outcomes (4)
Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.
This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated glomerular filtration rate (GFR) and proteinuria
Measured: From baseline to 30 days
Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.
This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated GFR and proteinuria
Measured: From baseline to 120 days
Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.
This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated GFR and proteinuria
Measured: From baseline to 210 days
Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.
This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated GFR and proteinuria
Measured: at 300 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start9 May 2019
- Primary completion16 Mar 2022
- Study completion16 Mar 2022
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.
- Other trials for Renal Transplant InfectionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Graham C. Towns, University of Alabama at Birmingham
- Investigators
- Graham C Towns, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762473
- Sponsor's protocol ID
- IRB-300001068
- Status last verified
- Jul 2023
- First submitted
- 27 Aug 2018
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversion From Tacrolimus to Envarsus in Rapid Metabolizers Post Kidney Transplant Protects Against BK Infection
- ClinicalTrials.gov ID
- NCT03762473
- Acronym / sponsor ID
- IRB-300001068
- Conditions
- Renal Transplant Infection
- Keywords
- Envarsus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 9 May 2019 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Posted 27 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess if the use of Envarsus in place of Tacrolimus-immediate release (IR) in rapid metabolizers post kidney transplant will reduce incidence of BK infection. Efficacy evaluations will include measurement of urine and serum BK values at specified time points and review of any biopsy for BK virus nephropathy. Incidence of rejection, graft failure, and graft dysfunction will also be measured at specified time points.
Detailed description
This will be a single center prospective case control study. The investigators expect 40% of patients will develop BK viruria, 20% BK viremia, 5% BK viral nephropathy (BKVN). Patients will be managed using standard of care for the investigator's center (thymoglobulin induction, tacrolimus/mycophenolate/prednisone). Target tacrolimus level is 8-12 ng/mL for the first 6 months post transplant and 6-9 ng/mL thereafter. BK urine/serum is monitored at 1, 3, 6, 9, 2 months post transplant. A population of 100 patients is calculated to show significant difference for p value < 0.05.
Population:
Study Group: Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at post-transplant month 1, who have a tacrolimus concentration/dose of < 1 and a steady state therapeutic level will be eligible. Patients who consent will be converted to Envarsus at 20% reduction in tacrolimus dose.
Control Group: Post transplant patients (kidney transplant alone performed between 10-2016 and time of enrollment) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at post-transplant month 1 and tacrolimus concentration/dose of < 1 at post-transplant month 1, and BK data available for months 2, 3, 6, 9,12 post transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Drug: Study GroupPost transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of < 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose. |
| Control Group | Active comparator | Drug: Control GroupPost transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of < 1 at month 1, and BK data available and month 2,3, 6,9,12. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years of age at the time of study entry
- Recipient of a deceased or living donor kidney transplantation
- Maintenance immunosuppression consisting of tacrolimus/ mycophenolate mofetil (MMF)/mycophenolic acid (MPA) (≥1000 mg/720 mg daily) ± prednisone (≤10 mg/day)
- Patient is less than or at 8 weeks post transplant with a negative serum BK Virus screen at 3-4 weeks post transplant
- Patient has a tacrolimus drug dose/concentration of > 1 with therapeutic tacrolimus levels.
Key exclusion criteria (10 listed)
- Inability or unwillingness of a patient to give written informed consent or comply with study protocol
- History of graft loss from acute rejection within 1 year after any previous kidney transplant
- History of previous liver, heart, pancreas, or lung transplant
- History of cellular rejection of current allograft prior to enrollment.
- Serum BK virus ≥500 copies/ml by polymerase chain reaction (PCR) at the time of study entry
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 |
|---|---|---|
| Study GroupAlso: tacrolimus extended-release tabletsPatients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels. | Drug | Study Group |
| Control GroupAlso: TacrolimusPost transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of < 1 at month 1, and BK data available and month 2,3, 6,9,12. | Drug | Control Group |
Primary outcome
Participants Will Experience Less BK Infection Episodes Based on Viruria Results.
Time frame: From baseline to 30 days
The evidence of BK virus infection will be measured by viruria >500 copies.
Participants Will Experience Less BK Infection Episodes Based on Viremia Results.
Time frame: From baseline to 30 days
The evidence of BK virus infection will be measured by viremia >500 copies.
Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.
Time frame: From baseline to 30 days
The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).
Participants Will Experience Less BK Infection Episodes Based on Viruria Results.
Time frame: From baseline to 120 days
The evidence of BK virus infection will be measured by viruria >500 copies.
Participants Will Experience Less BK Infection Episodes Based on Viremia Results.
Time frame: From baseline to 120 days
The evidence of BK virus infection will be measured by viremia >500 copies.
Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.
Time frame: From baseline to 120 days
The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).
Participants Will Experience Less BK Infection Episodes Based on Viruria Results.
Time frame: From baseline to 210 days
The evidence of BK virus infection will be measured by viruria >500 copies.
Participants Will Experience Less BK Infection Episodes Based on Viremia Results.
Time frame: From baseline to 210 days
The evidence of BK virus infection will be measured by viremia >500 copies.
Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.
Time frame: From baseline to 210 days
The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).
Number of Participants With Viruria >500 Copies
Time frame: at 300 days
Participants will experience less BK infection episodes based on viruria reported with >500 copies.
Participants Will Experience Less BK Infection Episodes Based on Viremia Results.
Time frame: at 300 days
The evidence of BK virus infection will be measured by viremia >500 copies.
Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.
Time frame: at 300 days
The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).
Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.
Time frame: From baseline to 30 days
Safety will be assessed for all Grade 3 or higher infection
Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.
Time frame: From baseline to 120 days
Safety will be assessed for all Grade 3 or higher infection
Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.
Time frame: From baseline to 210 days
Safety will be assessed for all Grade 3 or higher infection
Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.
Time frame: at 300 days
Safety will be assessed for all Grade 3 or higher infection
4 secondary outcomes
Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.
Time frame: From baseline to 30 days
Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.
Time frame: From baseline to 120 days
Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.
Time frame: From baseline to 210 days
Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.
Time frame: at 300 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Graham C Towns, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Study Group in people with Renal Transplant Infection, run by University of Alabama at Birmingham 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 7 inclusion and 10 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 27 Jul 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 27 Jul 2023). 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?
Participants Will Experience Less BK Infection Episodes Based on Viruria Results. (time frame: From baseline to 30 days). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2023.