Cyclosporine A in Chronic Renal Failure - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Chronic Renal Failure

Intervention / Treatment

Drug: cyclosporine A

Detailed Description

Our primary aim is to investigate if cyclosporine A may reduce insulin secretion by 20% or more. In order to get cyclosporine A naïve patients we will perform this investigation in dialysis patients on the waiting list for a renal transplantation. In addition we will investigate if also the peripheral insulin sensitivity and endothelia function is affected by cyclosporine A treatment in these patients. Since these patients will be treated with cyclosporine A we will also measure cyclosporine pharmacokinetics at the time of investigation and repeat this investigation at the time of the first week following transplantation in order to evaluate if a pretransplant cyclosporine dose can be of value in predefining the dose to be used at the time of transplantation.

Study Type

Interventional

Enrollment

16

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Renal failure patients on dialysis which is planned to receive a renal transplant

Exclusion Criteria:

Age below 18 years or above 75 years
Pregnancy
Breast feeding mothers
Diabetes mellitus /WHO criteria)
Dialysis treatment less than 2 months
Serious coronary heart disease
Unstable angina pectoris
Recent acute infarction (less than 3 months)
Non-compensated heart failure
Simultaneous treatment with glucocorticosteroids (e.g. prednisolone, dexamethasone), diltiazem, verapamil, erythromycin, clarithromycin, telithromycin, rifampicin, fluconazole, itraconazole, ketoconazole, voriconazole, indinavir, nelfinavir, ritonavir, nefazodone, bosentan, carbamazepine, St. John's worth, grapefruit.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Insulin secretion

Secondary Outcome Measures

Outcome Measure
Pharmacokinetics
Endothelial function
Peripheral insulin sensitivity

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

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

April 1, 2005

Primary Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria