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This study was designed to compare 3 immunosuppression regimens: sirolimus and tacrolimus versus everolimus and tacrolimus versus mycophenolate and tacrolimus.
The primary outcome is the incidence of cytomegalovirus infection / disease, a relevant medical need in the absence of pharmacological prophylaxis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sirolimus +tacrolimus | Experimental | Patients will receive initial dose of 0,05 mg/kg BID oftacrolimus to reach blood trough concentration between 3-5 ng/mL. Initial dose of sirolimus of 3mg once a day to reach blood trough concentration between 4-8 ng/mL. |
|
| everolimus +tacrolimus | Experimental | Patients will receive initial dose of 0,05 mg/kg BID de tacrolimus to reach blood trough concentration between 3-5 ng/mL. Initial dose of 1.5 mg BID of everolimus to reach blood trough concentration between 4-8 ng/mL. |
|
| mycophenolate +tacrolimus | Active Comparator | Patients will receive initial dose of 0,1 mg/kg BID de tacrolimusto reach blood trough concentration between Fixed dose of mycophenolate (mycophenolate mofetil, 1 g BID or sodium mycophenolate, 720 mg BID). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus | Drug | sirolimus combined to reduced dose of tacrolimus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Cytomegalovirus Infection or Disease | Incidence of CMV infection/disease in three study groups (SRL, EVR anda MPS). | 12 months follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital do Rim | São Paulo | São Paulo | 04038002 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37525373 | Derived | Toniato de Rezende Freschi J, Cristelli MP, Viana LA, Ficher KN, Nakamura MR, Proenca H, Dreige YC, de Marco R, de Lima MG, Foresto RD, Aguiar WF, Medina-Pestana J, Tedesco-Silva H. A Head-to-head Comparison of De Novo Sirolimus or Everolimus Plus Reduced-dose Tacrolimus in Kidney Transplant Recipients: A Prospective and Randomized Trial. Transplantation. 2024 Jan 1;108(1):261-275. doi: 10.1097/TP.0000000000004749. Epub 2023 Aug 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sirolimus +Tacrolimus | Patients will receive initial dose of 0,05 mg/kg BID oftacrolimus to reach blood trough concentration between 3-5 ng/mL. Initial dose of sirolimus of 3mg once a day to reach blood trough concentration between 4-8 ng/mL. Sirolimus: sirolimus combined to reduced dose of tacrolimus |
| FG001 | Everolimus +Tacrolimus | Patients will receive initial dose of 0,05 mg/kg BID de tacrolimus to reach blood trough concentration between 3-5 ng/mL. Initial dose of 1.5 mg BID of everolimus to reach blood trough concentration between 4-8 ng/mL. Everolimus: everolimus combined to reduced dose of tacrolimus |
| FG002 | Mycophenolate +Tacrolimus | Patients will receive initial dose of 0,1 mg/kg BID de tacrolimusto reach blood trough concentration between Fixed dose of mycophenolate (mycophenolate mofetil, 1 g BID or sodium mycophenolate, 720 mg BID). Mycophenolic acid: Control arm: mycophenolate combined to regular tacrolimus |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sirolimus +Tacrolimus | Patients will receive initial dose of 0,05 mg/kg BID oftacrolimus to reach blood trough concentration between 3-5 ng/mL. Initial dose of sirolimus of 3mg once a day to reach blood trough concentration between 4-8 ng/mL. Sirolimus: sirolimus combined to reduced dose of tacrolimus |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Incidence of Cytomegalovirus Infection or Disease | Incidence of CMV infection/disease in three study groups (SRL, EVR anda MPS). | Posted | Count of Participants | Participants | 12 months follow up |
|
12 months
Number of episodes of serious adverse events in each study group.
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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 | Sirolimus +Tacrolimus | Patients will receive initial dose of 0,05 mg/kg BID oftacrolimus to reach blood trough concentration between 3-5 ng/mL. Initial dose of sirolimus of 3mg once a day to reach blood trough concentration between 4-8 ng/mL. Sirolimus: sirolimus combined to reduced dose of tacrolimus |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CMV infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Helio Tedesco Silva Junior | Hospital do Rim - Fundação Oswaldo Ramos | 55 11 50878113 | heliotedesco@medfarm.com.br |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 3, 2020 | Nov 4, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D000068338 | Everolimus |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 |
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| Everolimus | Drug | everolimus combined to reduced dose of tacrolimus |
|
|
| Mycophenolic acid | Drug | Control arm: mycophenolate combined to regular tacrolimus |
|
|
| Everolimus +Tacrolimus |
Patients will receive initial dose of 0,05 mg/kg BID de tacrolimus to reach blood trough concentration between 3-5 ng/mL. Initial dose of 1.5 mg BID of everolimus to reach blood trough concentration between 4-8 ng/mL. Everolimus: everolimus combined to reduced dose of tacrolimus |
| BG002 | Mycophenolate +Tacrolimus | Patients will receive initial dose of 0,1 mg/kg BID de tacrolimusto reach blood trough concentration between Fixed dose of mycophenolate (mycophenolate mofetil, 1 g BID or sodium mycophenolate, 720 mg BID). Mycophenolic acid: Control arm: mycophenolate combined to regular tacrolimus |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Mycophenolate +Tacrolimus | Patients will receive initial dose of 0,1 mg/kg BID de tacrolimusto reach blood trough concentration between Fixed dose of mycophenolate (mycophenolate mofetil, 1 g BID or sodium mycophenolate, 720 mg BID). Mycophenolic acid: Control arm: mycophenolate combined to regular tacrolimus |
|
|
| 2 |
| 86 |
| 43 |
| 86 |
| 0 |
| 86 |
| EG001 | Everolimus +Tacrolimus | Patients will receive initial dose of 0,05 mg/kg BID de tacrolimus to reach blood trough concentration between 3-5 ng/mL. Initial dose of 1.5 mg BID of everolimus to reach blood trough concentration between 4-8 ng/mL. Everolimus: everolimus combined to reduced dose of tacrolimus | 1 | 90 | 47 | 90 | 0 | 90 |
| EG002 | Mycophenolate +Tacrolimus | Patients will receive initial dose of 0,1 mg/kg BID de tacrolimusto reach blood trough concentration between Fixed dose of mycophenolate (mycophenolate mofetil, 1 g BID or sodium mycophenolate, 720 mg BID). Mycophenolic acid: Control arm: mycophenolate combined to regular tacrolimus | 3 | 90 | 71 | 90 | 0 | 90 |
| Dehiscence of the aponeurosis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Acute graft dysfunction | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Renal artery stenosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Acute gastroenterocolitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pyelonephritis | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Acute graft rejection | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sepsis of pulmonary focus | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Infection of the operative wound | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sars-Cov-2 infection | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Other | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
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| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |