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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
| Astellas Pharma Inc | INDUSTRY |
The purpose of this study is to address the pharmacokinetic (PK) profiles of everolimus and tacrolimus in combination in de novo kidney transplant recipients, comparing 1.5 and 3 mg per day of everolimus in fixed doses. For comparison purposes, pharmacokinetic profiles will be performed at first dose (abbreviated), 4th day, 14th day, and 42nd day post-transplantation.
To address the pharmacokinetic profiles of everolimus and tacrolimus in combination in de novo kidney transplant recipients, comparing 1.5 and 3 mg per day of everolimus in fixed doses. For comparison purposes, pharmacokinetic profiles will be performed at first dose (abbreviated), 4th day, 14th day, and 42nd day post-transplantation. Patients will receive triple therapy steroids, tacrolimus and everolimus. Tacrolimus will be administered at a dose of 0.15 mg/kg/day to achieve 10-15 ng/ml 14 days, and 5-10 thereafter. During the first 6 weeks (the PK study period) everolimus will be assigned to fixed dose of 0.75 or 1.5 mg bid. After day 42, everolimus will be adjusted for 3-8 ng/ml and tacrolimus minimized to optimize graft function. Efficacy and safety parameters at 6 months post-transplantation will be secondary endpoints.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| everolimus and tacrolimus | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 12-hour PK profiles of everolimus and tacrolimus on day 14 post-transplantation with everolimus 1.5 mg versus 3 mg per day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julio Pascual, MD | Contact | +34 91 3368018 | julpascual@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Julio Pascual, MD | Hospital Universitario Ramon y Cajal | Study Chair |
| Gorka G Erauzquin, MD | Hospital de Cruces, Bilbao | Principal Investigator |
| José M Morales, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Ramón y Cajal | Recruiting | Madrid | 28034 | Spain |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Hospital 12 de Octubre, Madrid |
| Principal Investigator |
| Luis Pallardó, MD | Hospital Dr Peset, Valencia | Principal Investigator |
| Ricardo Lauzurica, MD | Hospital Germans, Trias i Puyol, Badalona | Principal Investigator |
| Domingo del Castillo, MD | Hospital Reina Sofía, Córdoba | Principal Investigator |
| Josep M Grinyó, MD | Hospital de Bellvitge, Barcelona | Principal Investigator |
| D052801 | Male Urogenital Diseases |