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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mTOR-receiving arm | Experimental | switching from calcineurin-inhibitor-based immunosuppression to mTOR-based immunosuppression |
|
| calcineurin-inhibitor keeping arm | Active Comparator | continuing calcineurin-inhibitor based immunosuppression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mTOR inhibitor (everolimus) | Drug | calcineurin-inhibitor based immunosuppression will be switched to immunosuppression based on m-TOR inhibitor (everolimus trough level 3-7ng/mL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years of observation |
| Measure | Description | Time Frame |
|---|---|---|
| decrease of polyomavirus serum PCR | regular measurement of polyomavirus serum PCR (every 4 weeks to 3 months) | 2 years |
| decrease of creatinine | regular measurment of graft function (every 4 weeks to 3 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anke Schwarz, Prof. Dr. | Contact | +49 511 532 2329 | schwarz.anke@mh-hannover.de | |
| Hermann Haller, Prof. Dr. | Contact | +49 511 5326319 | haller.hermann@mh-hannover.de |
| Name | Affiliation | Role |
|---|---|---|
| Anke Schwarz, Prof. Dr. | Hannover Medical School, Nephrology | Principal Investigator |
| Hermann Haller, Prof. Dr. | Hannover Medical School, Nephrology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Freiburg, Transplant Outpatient Clinic | Freiburg im Breisgau | Baden-Wurttemberg | D-79104 | Germany |
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|
| cyclosporine or tacrolimus | Drug | calcineurin inhibitor (cyclosporine or tacrolimus) will be continued (trough level 60-90ng/mL resp 3-7ng/mL) |
|
|
| 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 | 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 | 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) | 2 years observation |
| Silvia Linnenweber, Dr. |
| Hannover Medical School, Nephrology |
| Study Chair |
| Armin Koch, Prof. Dr. | Hannover Medical School, Biometry | Study Director |
| Albert Heim, PD Dr. | Hannover Medical School, Virology | Study Director |
| Verena Broecker, Dr. | Hannover Medical School, Pathology | Study Chair |
| University of Erlangen/ Nürnberg, Transplant Outpatient Clinic | Erlangen | Bavaria | D-91054 | Germany |
|
| Hannover Medical School, Transplant Outpatient Clinic | Hanover | Lower Saxony | D-30625 | Germany |
|
| University of Essen, Transplant Outpatient Clinic | Essen | Ruhrgebiet | D-45122 | Germany |
|
| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D000068338 | Everolimus |
| D016572 | Cyclosporine |
| D016559 | Tacrolimus |
| D065095 | Calcineurin Inhibitors |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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