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Transplant recipients have a high risk to develop skin malignancies. This effect depends on the one hand on the immunosuppressive drugs themselves (i.e., azathioprine) and relates on the other hand on the dosage (i.e., calcineurin-inhibitors). Based on the encouraging results of previous, retrospective studies on patients treated with Sirolimus (SRL), these patients should be switched to an immunosuppressive regime including SRL, decreasing the dosage of calcineurin-inhibitors or converting from former immunosuppression. A conversion to a SRL-based therapy is effective in immunosuppression and safe regarding graft and patient survival.
This study was designed to assess whether a switch to a SRL-immunosuppressive therapy decreases the incidence/reoccurrence of skin neoplasm.
Patients who meet all inclusion criteria will be included into the study and randomised. If converted to SRL, patients will take SRL according to the investigator's instructions and medication label, once daily preferably 4 hours after calcineurin-inhibitor medication or in case without calcineurin-inhibitor co-medication in the morning. The dose of SRL will be correlated to the former immunosuppressive therapy according to the study's conversion protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Sirolimus | Experimental | Patients will receive Sirolimus in addition to their previous immunosuppressive therapy. |
|
| 2 Standard | Active Comparator | Patients will stay on their previous immunosuppressive regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus | Drug | Treatment arm Dosage: 4-8 micrograms/litre; Route of administration: oral use; Frequency: one tablet per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Events of Reoccurrence of Skin Cancer | Progression of actinic keratosis I and II to III or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors (namely SCC, basal cell carcinoma, keratoacanthoma, Bowen's disease, precancerous keratoses, actinic keratoses III) | 24 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Petra Reinke, Prof. Dr. | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Erlangen, Hautklinik | Erlangen | Bavaria | 91052 | Germany | ||
| Universitätsklinikum Erlangen, Medizinische Klinik IV |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Sirolimus | Patients will receive Sirolimus in addition to their previous immunosuppressive therapy. Sirolimus: Treatment arm Dosage: adapted to serum level: 4-8 micrograms/litre; Route of administration: oral use; Frequency: once per day (Tablets) |
| FG001 | 2 Standard |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Azathioprine | Drug | control arm Dosage form: Coated tablet; dosage: 1-4 milligrams/kilogram; Frequency: daily; Duration: 24 month |
|
|
| Mycophenolate | Drug | Control arm Dosage form: Tablet; dosage: 2 gram; Frequency: daily; Duration: 24 month |
|
|
| Ciclosporin | Drug | Control arm Dosage form: Capsule; Dosage: 50-80 micrograms/litre; Frequency: daily; Duration: 24 month |
|
|
| Tacrolimus | Drug | Control arm Dosage form: Capsule; dosage: 3-5 micrograms/litre; Frequency: daily; Duration: 24 month |
|
|
| Erlangen |
| Bavaria |
| 91054 |
| Germany |
| Klinikum der LMU München, Medizinische Poliklinik Innenstadt | München | Bavaria | 80336 | Germany |
| Klinikum der LMU München, Klinik und Poliklinik für Dermatologie | München | Bavaria | 80337 | Germany |
| Klinikum rechts der Isar, Klinik und Poliklinik für Dermatologie und Allergologie | München | Bavaria | 80802 | Germany |
| Klinikum rechts der Isar, II. Medizinische Klinik und Poliklinik | München | Bavaria | 81675 | Germany |
| Universität Regensburg, Dermatologie | Regensburg | Bavaria | 93053 | Germany |
| Universität Regensburg, Nephrologie Innere Medizin II | Regensburg | Bavaria | 93053 | Germany |
| Kliniken der Stadt Köln, Medizinische Klinik I | Cologne | North Rhine-Westphalia | 51109 | Germany |
| Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten | Münster | North Rhine-Westphalia | 48149 | Germany |
| Universitätsklinikum Münster, Med. Klinik und Poliklinik D | Münster | North Rhine-Westphalia | 48149 | Germany |
| HELIOS Klinikum Wuppertal, Zentrum für Dermatologie, Allergologie und Umweltmedizin | Wuppertal | North Rhine-Westphalia | 42283 | Germany |
| Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Venerologie und Allergologie | Kiel | Schleswig-Holstein | 24105 | Germany |
| Universitätsklinikum Schleswig-Holstein, Klinik für Nieren- und Hochdruckkrankheiten | Kiel | Schleswig-Holstein | 24105 | Germany |
| Charité Universitätsmedizin, Klinik für Dermatologie, Venerologie und Allergologie | Berlin | 10117 | Germany |
Patients will stay on their previous immunosuppressive regimen. Azathioprine: control arm Dosage form: Coated tablet; dosage: 1-4 milligrams/kilogram; Frequency: daily; Duration: 24 month Mycophenolate: Control arm Dosage form: Tablet; dosage: 2 gram; Frequency: daily; Duration: 24 month Ciclosporin: Control arm Dosage form: Capsule; Dosage adapted to serum level: 50-80 micrograms/litre; Frequency: daily; Duration: 24 month Tacrolimus: Control arm Dosage form: Capsule; dosage adapted to serum level: 3-5 micrograms/litre; Frequency: daily; Duration: 24 month |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Sirolimus | Patients will receive Sirolimus in addition to their previous immunosuppressive therapy. Sirolimus: Treatment arm Dosage adapted to serum level: 4-8 micrograms/litre; Route of administration: oral use; Frequency: once per day (Tablets) |
| BG001 | 2 Standard | Patients will stay on their previous immunosuppressive regimen. Azathioprine: control arm Dosage form: Coated tablet; dosage: 1-4 milligrams/kilogram; Frequency: daily; Duration: 24 month Mycophenolate: Control arm Dosage form: Tablet; dosage: 2 gram; Frequency: daily; Duration: 24 month Ciclosporin: Control arm Dosage form: Capsule; Dosage adapted to serum level: 50-80 micrograms/litre; Frequency: daily; Duration: 24 month Tacrolimus: Control arm Dosage form: Capsule; dosage adapted to serum level: 3-5 micrograms/litre; Frequency: daily; Duration: 24 month |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Events of Reoccurrence of Skin Cancer | Progression of actinic keratosis I and II to III or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors (namely SCC, basal cell carcinoma, keratoacanthoma, Bowen's disease, precancerous keratoses, actinic keratoses III) | Posted | Number | Event | 24 month |
|
|
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 Sirolimus | Patients will receive Sirolimus in addition to their previous immunosuppressive therapy. Sirolimus: Treatment arm Dosage adapted to Serum level: 4-8 micrograms/litre; Route of administration: oral use; Frequency: once per day (tablet) | 0 | 25 | 15 | 25 | 19 | 25 |
| EG001 | 2 Standard | Patients will stay on their previous immunosuppressive regimen. Azathioprine: control arm Dosage form: Coated tablet; dosage: 1-4 milligrams/kilogram; Frequency: daily; Duration: 24 month Mycophenolate: Control arm Dosage form: Tablet; dosage: 2 gram; Frequency: daily; Duration: 24 month Ciclosporin: Control arm Dosage form: Capsule; Dosage adapted to Serum level 50-80 micrograms/litre; Frequency: daily; Duration: 24 month Tacrolimus: Control arm Dosage form: Capsule; dosage adapted to Serum level 3-5 micrograms/litre; Frequency: daily; Duration: 24 month | 0 | 19 | 7 | 19 | 9 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Multiple squamous cell carcinomas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Petra Reinke | Charité Universitätsmedizin Berlin Augustenburger Platz 1 13353 Berlin | +49 30 450 653 490 | petra.reinke@charite.de |
| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D001379 | Azathioprine |
| D009173 | Mycophenolic Acid |
| D016572 | Cyclosporine |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| >=65 years |
|
| Male |
|