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Effects of Cyclosporine A on Pancreatic Insulin Secretion

This study has been completed.
Information provided by:
University of Oslo School of Pharmacy Identifier:
First received: August 29, 2005
Last updated: October 31, 2012
Last verified: October 2012
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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00139035

Rikshospitalet, Section of Nephrology
Oslo, Norway, 0027
Sponsors and Collaborators
University of Oslo School of Pharmacy
Study Director: Anders Åsberg, MSc University of Oslo
  More Information Identifier: NCT00139035     History of Changes
Other Study ID Numbers: CsA-Dialysis 2004-004488-3 
Study First Received: August 29, 2005
Last Updated: October 31, 2012
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by University of Oslo School of Pharmacy:
glucose intolerance
microvascular function
renal transplantation

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
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 processed this record on October 27, 2016