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Effects of Cyclosporine A on Pancreatic Insulin Secretion

This study has been completed.
Sponsor:
Information provided by:
University of Oslo School of Pharmacy
ClinicalTrials.gov Identifier:
NCT00139035
First received: August 29, 2005
Last updated: October 31, 2012
Last verified: October 2012
History of Changes
  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
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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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
insulin
microvascular function
genotyping
 CYP3A5
pharmacokinetics
renal transplantation

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

ClinicalTrials.gov processed this record on May 23, 2013