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Insulin Secretion and Advagraf

NCT01092806 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-12-03

No results posted yet for this study

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.

Conditions

  • Post Transplant Diabetes Mellitus

Interventions

DRUG

Tacrolimus

Two different formulations of the drug is compared. The dose is adjusted according to whole blood concentrations in accordance with center protocol. Switch between the two formulations are done by a 1:1 conversion of daily dose.

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • University of Oslo School of Pharmacy

    lead OTHER

Principal Investigators

  • Karsten Midtvedt, MD, PhD · Oslo University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01092806 on ClinicalTrials.gov