Kidney Diseases
Conditions
Keywords
Kidney Transplantation
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
Novartis
Astellas Pharma Inc
Hospital Universitario Ramon y Cajal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Kidney transplant recipients aged 18-65 years old with a presumed immediately functioning graft
Exclusion criteria
* Non-functioning kidneys
Design outcomes
Primary
| Measure | 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 | — |
Countries
Spain
Contacts
Primary ContactJulio Pascual, MD
Outcome results
None listed