Cyclosporine and Cyclosporins and Cyclosporine A in Heart Transplantation and Renal Transplantation - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: Cyclosporine A

Detailed Description

The primary objective is to investigate intralymphocyte concentrations of CsA in renal and heart transplant recipients to elucidate the association between the intracellular concentration and efficacy (rejection episodes and histology) in transplanted patients on CsA based immunosuppressive therapy.

Secondary objectives are to investigate associations between intralymphocyte concentrations and whole-blood concentrations of CsA, renal tissue concentrations and nephrotoxicity, heart tissue concentrations and cardiotoxicity with CsA based immunosuppressive therapy in transplanted patients. In addition, this study aims to validate the use of quinine as a probe for determination of CYP3A4 activity in transplanted patients as well as proteomic-based urine analyses as a screening tool for acute rejection episodes in transplanted patients.

Study Type

Interventional

Enrollment

30

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Norway
- - Oslo, Norway, 0027
    - Rikshospitalet, Section of Nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Renal or heart transplant recipients scheduled to receive CsA as part of their immunosuppressive therapy at the time of transplantation.
18 years of age or older.
Signed informed consent.

Exclusion Criteria:

Known contraindications for renal or heart biopsies, respectively, at the time of inclusion.
Concomitant treatment with: diltiazem, verapamil, phenytoin, carbamazepine, fluconazole, ketoconazole, erythromycin, clarithromycin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
rejection
pharmacokinetics

Secondary Outcome Measures

Outcome Measure
toxicity
genotypes
metabolites

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo School of Pharmacy

Investigators

Study Director: Anders Åsberg, MSc, University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Loftheim H, Midtvedt K, Hartmann A, Reisaeter AV, Falck P, Holdaas H, Jenssen T, Reubsaet L, Asberg A. Urinary proteomic shotgun approach for identification of potential acute rejection biomarkers in renal transplant recipients. Transplant Res. 2012 Aug 31;1(1):9. doi: 10.1186/2047-1440-1-9.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria