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Pharmacokinetic Study on the Combination of Everolimus-Tacrolimus

Primary Purpose

Kidney Diseases

Status

Unknown status

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

everolimus and tacrolimus

About this trial

This is an interventional treatment trial for Kidney Diseases focused on measuring Kidney Transplantation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Kidney transplant recipients aged 18-65 years old with a presumed immediately functioning graft Exclusion Criteria: Non-functioning kidneys

Sites / Locations

Hospital Ramón y CajalRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00325325

First Posted

May 11, 2006

Last Updated

October 25, 2006

Sponsor

Hospital Universitario Ramon y Cajal

Collaborators

Novartis, Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT00325325

Brief Title

Pharmacokinetic Study on the Combination of Everolimus-Tacrolimus

Official Title

A Pilot Study to Investigate Pharmacokinetic Characteristics of Everolimus in Patients Treated With Tacrolimus-Based Immunosuppression in De Novo Kidney Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

May 2006

Overall Recruitment Status

Unknown status

Study Start Date

January 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital Universitario Ramon y Cajal

Collaborators

Novartis, Astellas Pharma Inc

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Diseases

Keywords

Kidney Transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

everolimus and tacrolimus

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Kidney transplant recipients aged 18-65 years old with a presumed immediately functioning graft Exclusion Criteria: Non-functioning kidneys

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Julio Pascual, MD

Phone

+34 91 3368018

julpascual@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julio Pascual, MD

Organizational Affiliation

Hospital Universitario Ramon y Cajal

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Gorka G Erauzquin, MD

Organizational Affiliation

Hospital de Cruces, Bilbao

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

José M Morales, MD

Organizational Affiliation

Hospital 12 de Octubre, Madrid

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Luis Pallardó, MD

Organizational Affiliation

Hospital Dr Peset, Valencia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ricardo Lauzurica, MD

Organizational Affiliation

Hospital Germans, Trias i Puyol, Badalona

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Domingo del Castillo, MD

Organizational Affiliation

Hospital Reina Sofía, Córdoba

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Josep M Grinyó, MD

Organizational Affiliation

Hospital de Bellvitge, Barcelona

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Ramón y Cajal

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Julio Pascual, MD

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetic Study on the Combination of Everolimus-Tacrolimus

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