Disorder Related to Renal TransplantationPhase 4BKVIRUSNCT01289301
Studying the Effect of Changing Immunosuppression in Case of Polyoma BK Virus Infection of the Renal Transplant
A Phase 4 study testing mTOR inhibitor (everolimus) and cyclosporine or tacrolimus in people with Disorder Related to Renal Transplantation and Immunosuppression Related Infectious Disease, run by Hannover Medical School at 4 sites in Germany.
Trial summary
Polyomavirus BK nephropathy is a serious complication after renal transplantation leading to graft loss in 40% of cases. Since no virustatic drug exists, the investigators want to study the best way to manage viral invasion by changing the immunosuppressive treatment comparing two treatment schemes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorder Related to Renal Transplantation, Immunosuppression Related Infectious Disease, Virus Diseases
- What is being tested?
- mTOR inhibitor (everolimus) and cyclosporine or tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 4 sitesGermany
- Study dates
- Oct 2011to Oct 2018
- Phase
- Phase 4
- 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
Who may be able to join
- preceding renal transplantation
- functioning graft with a permanent creatinine clearance of more than 25mL/min
- biopsy-confirmed polyoma BK virus nephropathy
- age over 18 years old
Who cannot join
- allergy or non-tolerance of the study medication everolimus
- pregnancy
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
University of Erlangen/ Nürnberg, Transplant Outpatient Clinic
Erlangen, Bavaria, D-91054
Karl Hilgers, Prof. Dr., +49 9131 8536267, karl.hilgers@uk-erlangen.de
University of Essen, Transplant Outpatient Clinic
Essen, Ruhrgebiet, D-45122
Oliver Witzke, Prof. Dr., +49 201 7231868, nephrologie@uk-essen.de
University Hospital Freiburg, Transplant Outpatient Clinic
Freiburg im Breisgau, Baden-Wurttemberg, D-79104
Gerd Walz, Prof. Dr., 0761 2703250, gerd.walz@uniklinik-freiburg.de
Hannover Medical School, Transplant Outpatient Clinic
Hanover, Lower Saxony, D-30625
Anke Schwarz, Prof. Dr., +49 511 5322329, schwarz.anke@mh-hannover.de
Silvia Linnenweber, Dr., +49 511 5323000, linnenweber.silvia@mh-hannover.de
About this study
Official title: Polyomavirus BK Nephropathy After Renal Transplantation: Randomized Clinical Trial to Demonstrate That Switching to mTOR Inhibitor is More Effective Than a Reduction of Immunosuppressive Therapy
Polyomavirus BK nephropathy is a serious complication after renal transplantation leading to graft loss in 40% of cases. Since no virustatic drug exists, the investigators want to study the best way to manage viral invasion by changing the immunosuppressive treatment comparing two treatment schemes. The investigators hypothesis is that switching to an mTOR-based scheme is superior to a general decrease of a calcineurin inhibitor (CNI)-based scheme. The study will be performed as a prospective, randomized, parallel group comparison.
Read the detailed description
The study group (n=62) will be switched from CNI to everolimus while the control group (n=62) will get a general reduction of the CNI-based immunosuppression. Follow-up and duration of intervention per patient will be 24 months, duration of the trial 72 months including 4 years of recruitment.
- Conditions
- Disorder Related to Renal Transplantation, Immunosuppression Related Infectious Disease, Virus Diseases
- Being tested
- mTOR inhibitor (everolimus), cyclosporine or tacrolimus
- Keywords
- renal transplantation, polyoma BK virus infection, everolimus, calcineurin inhibitor, mTOR inhibitor
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mTOR inhibitor (everolimus)Drug
Also called switch immunosuppression to everolimus
calcineurin-inhibitor based immunosuppression will be switched to immunosuppression based on m-TOR inhibitor (everolimus trough level 3-7ng/mL)
cyclosporine or tacrolimusDrug
Also called keeping immunosuppression with calcineurin inhibitor, cyclosporine, tacrolimus
calcineurin inhibitor (cyclosporine or tacrolimus) will be continued (trough level 60-90ng/mL resp 3-7ng/mL)
| Study group | Role | What they receive |
|---|---|---|
| mTOR-receiving arm | Experimental | switching from calcineurin-inhibitor-based immunosuppression to mTOR-based immunosuppression Receives: Drug: mTOR inhibitor (everolimus) |
| calcineurin-inhibitor keeping arm | Active comparator | continuing calcineurin-inhibitor based immunosuppression Receives: Drug: cyclosporine or tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
death or graft loss
after experimental intervention (switch to mTOR inhibitor in group 1) and control intervention (general reduction of immunosuppression) observation of graft function
Measured: 2 years of observation
Secondary outcomes (5)
decrease of polyomavirus serum PCR
regular measurement of polyomavirus serum PCR (every 4 weeks to 3 months)
Measured: 2 years
decrease of creatinine
regular measurment of graft function (every 4 weeks to 3 months)
Measured: 2 years observation
progression of chronic changes in renal histology
renal rebiopsy and comparison of chronic changes in renal biopsy with the diagnostic renal biopsy
Measured: renal biopsy 3 months after intervention
number of rejections following intervention
biopsy-verified rejections (graft biopsies on indication) may be a consequence of changement of immunosuppression and a side effect of it, rejections will be counted
Measured: 2 years after intervention
increase of BKV-specific T-cells
increase of BKV-specific T-cells are a sign of overcoming viral infection and will be counted regularly (every 3 to 6 months)
Measured: 2 years observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2017 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder Related to Renal TransplantationStudies of the same condition, open and under way.
- 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
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Investigators
- Anke Schwarz, Prof. Dr., Principal investigator, Hannover Medical School, NephrologyHermann Haller, Prof. Dr., Principal investigator, Hannover Medical School, NephrologySilvia Linnenweber, Dr., Study chair, Hannover Medical School, NephrologyArmin Koch, Prof. Dr., Study director, Hannover Medical School, BiometryAlbert Heim, PD Dr., Study director, Hannover Medical School, VirologyVerena Broecker, Dr., Study chair, Hannover Medical School, Pathology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289301
- Sponsor's protocol ID
- Polyoma IFB 29
- Acronym
- BKVIRUS
- Status last verified
- Oct 2010
- First submitted
- 2 Feb 2011
- Last updated
- 3 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyomavirus BK Nephropathy After Renal Transplantation: Randomized Clinical Trial to Demonstrate That Switching to mTOR Inhibitor is More Effective Than a Reduction of Immunosuppressive Therapy
- ClinicalTrials.gov ID
- NCT01289301
- Acronym / sponsor ID
- BKVIRUS / Polyoma IFB 29
- Conditions
- Disorder Related to Renal Transplantation, Immunosuppression Related Infectious Disease, Virus Diseases
- Keywords
- renal transplantation, polyoma BK virus infection, everolimus, calcineurin inhibitor, mTOR inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 3 Feb 2011 (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.
Polyomavirus BK nephropathy is a serious complication after renal transplantation leading to graft loss in 40% of cases. Since no virustatic drug exists, the investigators want to study the best way to manage viral invasion by changing the immunosuppressive treatment comparing two treatment schemes. The investigators hypothesis is that switching to an mTOR-based scheme is superior to a general decrease of a calcineurin inhibitor (CNI)-based scheme. The study will be performed as a prospective, randomized, parallel group comparison.
Detailed description
The study group (n=62) will be switched from CNI to everolimus while the control group (n=62) will get a general reduction of the CNI-based immunosuppression. Follow-up and duration of intervention per patient will be 24 months, duration of the trial 72 months including 4 years of recruitment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mTOR-receiving arm | Experimental | Drug: mTOR inhibitor (everolimus)switching from calcineurin-inhibitor-based immunosuppression to mTOR-based immunosuppression |
| calcineurin-inhibitor keeping arm | Active comparator | Drug: cyclosporine or tacrolimuscontinuing calcineurin-inhibitor based immunosuppression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- preceding renal transplantation
- functioning graft with a permanent creatinine clearance of more than 25mL/min
- biopsy-confirmed polyoma BK virus nephropathy
- age over 18 years old
Key exclusion criteria (2 listed)
- allergy or non-tolerance of the study medication everolimus
- pregnancy
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 |
|---|---|---|
| mTOR inhibitor (everolimus)Also: switch immunosuppression to everolimuscalcineurin-inhibitor based immunosuppression will be switched to immunosuppression based on m-TOR inhibitor (everolimus trough level 3-7ng/mL) | Drug | mTOR-receiving arm |
| cyclosporine or tacrolimusAlso: keeping immunosuppression with calcineurin inhibitor, cyclosporine, tacrolimuscalcineurin inhibitor (cyclosporine or tacrolimus) will be continued (trough level 60-90ng/mL resp 3-7ng/mL) | Drug | calcineurin-inhibitor keeping arm |
Primary outcome
death or graft loss
Time frame: 2 years of observation
after experimental intervention (switch to mTOR inhibitor in group 1) and control intervention (general reduction of immunosuppression) observation of graft function
5 secondary outcomes
decrease of polyomavirus serum PCR
Time frame: 2 years
decrease of creatinine
Time frame: 2 years observation
progression of chronic changes in renal histology
Time frame: renal biopsy 3 months after intervention
number of rejections following intervention
Time frame: 2 years after intervention
increase of BKV-specific T-cells
Time frame: 2 years observation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2011.
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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.
Anke Schwarz, Prof. Dr. principal investigator
Hannover Medical School, Nephrology
Hermann Haller, Prof. Dr. principal investigator
Hannover Medical School, Nephrology
Silvia Linnenweber, Dr. study chair
Hannover Medical School, Nephrology
4 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 mTOR inhibitor (everolimus) and cyclosporine or tacrolimus in people with Disorder Related to Renal Transplantation and Immunosuppression Related Infectious Disease, run by Hannover Medical School at 4 sites in Germany.
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 2 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: status not confirmed, as of the sponsor's last update on 3 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anke Schwarz, Prof. Dr. (+49 511 532 2329, schwarz.anke@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death or graft loss (time frame: 2 years of observation). 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 3 Feb 2011.