Effects of Cyclosporine A on Pancreatic Insulin Secretion

Chronic Renal Failure Clinical Trial

Official title:

Effects of Cyclosporine A on Pancreatic Insulin Secretion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00139035
• Other study ID #: CsA-Dialysis 2004-004488-3
• Status: Completed
• Phase: Phase 4
• First received: August 29, 2005
• Last updated: October 31, 2012
• Start date: April 2005

Study information

• Verified date: October 2012
• Source: University of Oslo School of Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic

Intervention

Drug:
• cyclosporine A

Locations

Country	Name	City	State
Norway	Rikshospitalet, Section of Nephrology	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo School of Pharmacy

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin secretion
Secondary	Peripheral insulin sensitivity
Secondary	Endothelial function
Secondary	Pharmacokinetics