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| Sponsors and Collaborators: |
Hospital Universitario Ramon y Cajal Novartis Astellas Pharma Inc |
| Information provided by: | Hospital Universitario Ramon y Cajal |
| ClinicalTrials.gov Identifier: | NCT00325325 |
Purpose
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.
| Condition | Intervention | Phase |
|
Kidney Diseases |
Drug: everolimus and tacrolimus |
Phase II |
| MedlinePlus related topics: | Kidney Transplantation |
| ChemIDplus related topics: | Tacrolimus Everolimus Tacrolimus anhydrous |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study |
| Official Title: | A Pilot Study to Investigate Pharmacokinetic Characteristics of Everolimus in Patients Treated With Tacrolimus-Based Immunosuppression in De Novo Kidney Transplantation |
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | June 2007 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Julio Pascual, MD | +34 91 3368018 | julpascual@gmail.com |
| Spain | |||||
| Hospital Ramón y Cajal | Recruiting | ||||
| Madrid, Spain, 28034 | |||||
| Principal Investigator: Julio Pascual, MD | |||||
| Hospital Universitario Ramon y Cajal |
| Novartis |
| Astellas Pharma Inc |
| Study Chair: | Julio Pascual, MD | Hospital Ramón y Cajal |
| Principal Investigator: | Gorka G Erauzquin, MD | Hospital de Cruces, Bilbao |
| Principal Investigator: | José M Morales, MD | 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 |
More Information
| Study ID Numbers: | EVEROTAC |
| First Received: | May 11, 2006 |
| Last Updated: | October 25, 2006 |
| ClinicalTrials.gov Identifier: | NCT00325325 |
| Health Authority: | Spain: Spanish Agency of Medicines |
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