Effects of Cyclosporine A on Pancreatic Insulin Secretion

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Brief Summary

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Our primary aim is to investigate if cyclosporine A reduces insulin secretion.

Detailed Description

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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.

Conditions

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Chronic Renal Failure

Keywords

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glucose intolerance insulin microvascular function genotyping CYP3A5 pharmacokinetics renal transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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cyclosporine A

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Anders Åsberg, MSc

Role: STUDY_DIRECTOR

University of Oslo

Locations

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Rikshospitalet, Section of Nephrology

Oslo, Oslo County, Norway

Site Status

Countries

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Norway

Other Identifiers

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CsA-Dialysis 2004-004488-3

Identifier Type: -

Identifier Source: org_study_id