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Effects of Cyclosporine A on Pancreatic Insulin Secretion

Primary Purpose

Chronic Renal Failure

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
cyclosporine A
Sponsored by
University of Oslo School of Pharmacy
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Renal Failure focused on measuring glucose intolerance, insulin, microvascular function, genotyping, CYP3A5, pharmacokinetics, renal transplantation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rikshospitalet, Section of Nephrology

Outcomes

Primary Outcome Measures

Insulin secretion

Secondary Outcome Measures

Peripheral insulin sensitivity
Endothelial function
Pharmacokinetics

Full Information

First Posted
August 29, 2005
Last Updated
October 31, 2012
Sponsor
University of Oslo School of Pharmacy
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1. Study Identification

Unique Protocol Identification Number
NCT00139035
Brief Title
Effects of Cyclosporine A on Pancreatic Insulin Secretion
Official Title
Effects of Cyclosporine A on Pancreatic Insulin Secretion
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Oslo School of Pharmacy

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure
Keywords
glucose intolerance, insulin, microvascular function, genotyping, CYP3A5, pharmacokinetics, renal transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cyclosporine A
Primary Outcome Measure Information:
Title
Insulin secretion
Secondary Outcome Measure Information:
Title
Peripheral insulin sensitivity
Title
Endothelial function
Title
Pharmacokinetics

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Åsberg, MSc
Organizational Affiliation
University of Oslo
Official's Role
Study Director
Facility Information:
Facility Name
Rikshospitalet, Section of Nephrology
City
Oslo
ZIP/Postal Code
0027
Country
Norway

12. IPD Sharing Statement

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Effects of Cyclosporine A on Pancreatic Insulin Secretion

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