Effects of Cyclosporine A on Pancreatic Insulin Secretion

University of Oslo School of Pharmacy

Status and phase

Completed

Phase 4

Conditions

Chronic Renal Failure

Treatments

Drug: cyclosporine A

Study type

Interventional

Funder types

Other

Identifiers

NCT00139035

CsA-Dialysis 2004-004488-3

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.