Insulin Secretion and Advagraf

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

One of the main side-effects of tacrolimus in solid organ transplanted patients is post transplant diabetes mellitus (PTDM). It is not known if different pharmacokinetic properties influence the risk of developing PTDM. It is possible that it either is high peak concentrations of high overall systemic exponation that is responsible for the effect on insulin secretion. With the new slow-release formulation of tacrolimus (Advagraf) a different pharmacokinetic profile is introduced to patients and it is of interest to investigate if this affects insulin secretion and insulin sensitivity of patients.

Hypothesis: The pharmacokinetic profile of tacrolimus affects the insulin secretion in renal transplant recipients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oslo School of Pharmacy
• Collaborator: Oslo University Hospital
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• Renal transplant recipients on stable Tac based immunosuppressive therapy.

• 18 years of age or older.

• Stable prednisolone dose of 5 mg/day or less.

• S-creatinine below 150 umol/L.

• Signed informed consent.

Exclusion Criteria:

• Acute rejection episodes within the last 2 weeks prior to inclusion.

• Changes in Tac dosing within the last 2 weeks prior to inclusion.

• Diabetes mellitus (WHO criteria).

• Pregnant or nursing mothers or women of childbearing potential without acceptable contraception strategy.

• Concomitant treatment with: diltiazem, verapamil, fenytoin, carbamazepine, fluconazole, ketoconazole, voriconazole, erythromycin, clarithromycin.

• Patients treated with investigational drugs.