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Pharmacokinetic Study on the Combination of Everolimus-Tacrolimus

NCT00325325 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2006-10-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

everolimus and tacrolimus

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Hospital Universitario Ramon y Cajal

    lead OTHER

Principal Investigators

  • Julio Pascual, MD · Hospital Universitario Ramon y Cajal

  • Gorka G Erauzquin, MD · Hospital de Cruces, Bilbao

  • José M Morales, MD · Hospital 12 de Octubre, Madrid

  • Luis Pallardó, MD · Hospital Dr Peset, Valencia

  • Ricardo Lauzurica, MD · Hospital Germans, Trias i Puyol, Badalona

  • Domingo del Castillo, MD · Hospital Reina Sofía, Córdoba

  • Josep M Grinyó, MD · Hospital de Bellvitge, Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Completion
2007-06-30

Countries

  • Spain

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00325325 on ClinicalTrials.gov