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OpenTrials
Completed

NCT Number: NCT00139035

Effects of Cyclosporine A on Pancreatic Insulin Secretion

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cyclosporine A

Drug

Primary outcomes

  1. Insulin secretion

Secondary outcomes

  1. Peripheral insulin sensitivity

  2. Endothelial function

  3. Pharmacokinetics

Sponsors and collaborators

Lead sponsor

University of Oslo School of Pharmacy

Other

Registry information

Important dates

Study start
2005
Primary completion
2006
First posted
Aug 30, 2005
Registry last updated
Nov 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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