MedDataX Logo

Pharmacokinetic Study on the Combination of Everolimus-Tacrolimus

NCT ID: NCT00325325

Last Updated: 2006-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Kidney Diseases

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Kidney Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

everolimus and tacrolimus

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Non-functioning kidneys
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role collaborator

Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Julio Pascual, MD

Role: STUDY_CHAIR

Hospital Universitario Ramon y Cajal

Gorka G Erauzquin, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Cruces, Bilbao

José M Morales, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital 12 de Octubre, Madrid

Luis Pallardó, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Dr Peset, Valencia

Ricardo Lauzurica, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Germans, Trias i Puyol, Badalona

Domingo del Castillo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Reina Sofía, Córdoba

Josep M Grinyó, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Bellvitge, Barcelona

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Ramón y Cajal

Madrid, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Julio Pascual, MD

Role: CONTACT

Phone: +34 91 3368018

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EVEROTAC

Identifier Type: -

Identifier Source: org_study_id