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Effects of Cyclosporine A on Pancreatic Insulin Secretion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00139035
First Posted: August 30, 2005
Last Update Posted: November 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Oslo School of Pharmacy
  Purpose
Our primary aim is to investigate if cyclosporine A reduces insulin secretion.

Condition Intervention Phase
Chronic Renal Failure Drug: cyclosporine A Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Cyclosporine A on Pancreatic Insulin Secretion

Resource links provided by NLM:


Further study details as provided by University of Oslo School of Pharmacy:

Primary Outcome Measures:
  • Insulin secretion

Secondary Outcome Measures:
  • Peripheral insulin sensitivity
  • Endothelial function
  • Pharmacokinetics

Estimated Enrollment: 16
Study Start Date: April 2005
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
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.
  Eligibility

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139035


Locations
Norway
Rikshospitalet, Section of Nephrology
Oslo, Norway, 0027
Sponsors and Collaborators
University of Oslo School of Pharmacy
Investigators
Study Director: Anders Åsberg, MSc University of Oslo
  More Information

ClinicalTrials.gov Identifier: NCT00139035     History of Changes
Other Study ID Numbers: CsA-Dialysis 2004-004488-3
First Submitted: August 29, 2005
First Posted: August 30, 2005
Last Update Posted: November 2, 2012
Last Verified: October 2012

Keywords provided by University of Oslo School of Pharmacy:
glucose intolerance
insulin
microvascular function
genotyping
CYP3A5
pharmacokinetics
renal transplantation

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Insulin
Cyclosporins
Cyclosporine
Hypoglycemic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors