NCT00325325

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

October 26, 2006

Status Verified

May 1, 2006

First QC Date

May 11, 2006

Last Update Submit

October 25, 2006

Conditions

Kidney Diseases

Keywords

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • 12-hour PK profiles of everolimus and tacrolimus on day 14 post-transplantation with everolimus 1.5 mg versus 3 mg per day

Interventions

everolimus and tacrolimusDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Kidney transplant recipients aged 18-65 years old with a presumed immediately functioning graft

You may not qualify if:

  • Non-functioning kidneys

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

MeSH Terms

Conditions

Kidney Diseases

Interventions

EverolimusTacrolimus

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Julio Pascual, MD

    Hospital Universitario Ramon y Cajal

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julio Pascual, MD

CONTACT

+34 91 3368018julpascual@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 11, 2006

First Posted

May 12, 2006

Study Start

January 1, 2006

Study Completion

June 1, 2007

Last Updated

October 26, 2006

Record last verified: 2006-05

Locations

ES(1)