Insulin Secretion and Advagraf (ADVA-09)

This study has been completed.
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by:
University of Oslo School of Pharmacy
ClinicalTrials.gov Identifier:
NCT01092806
First received: March 23, 2010
Last updated: October 21, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Post Transplant Diabetes Mellitus
Drug: Tacrolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects on Insulin Secretion and Sensitivity of Two Different Formulations Tacrolimus - Prograf® and Advagraf®

Resource links provided by NLM:


Further study details as provided by University of Oslo School of Pharmacy:

Primary Outcome Measures:
  • The primary objective is to compare insulin secretion (Secr2.phase) between the two different formulations of Tac. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Insulin secretion is investigated by hyperglycemic clamp


Secondary Outcome Measures:
  • Secondary objectives are to compare the effect of the two formulations on Secr1.phase, [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    First phase insulin secretion is investigated by hyperglycemic clamp

  • insulin sensitivity [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Investigated by hyperglycemic clamp


Estimated Enrollment: 20
Study Start Date: October 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prograf
Patients are treated until steady-state conditions with Prograf and then investigated with clamp
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.
Other Names:
  • Prograf (BID formulation)
  • Advagraf (QD formulation)
Experimental: Advagraf
The patients are treated with Advagraf until steady-state conditions and then investigated with clamp
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.
Other Names:
  • Prograf (BID formulation)
  • Advagraf (QD formulation)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01092806

Locations
Norway
Oslo univeristy hospital, Rikshospitalet
Oslo, Norway, 0027
Sponsors and Collaborators
University of Oslo School of Pharmacy
Oslo University Hospital
Investigators
Principal Investigator: Karsten Midtvedt, MD, PhD Oslo University Hospital Rikshospitalet
  More Information

No publications provided

Responsible Party: Anders Åsberg, Professor, School of Pharmacy, University of Oslo
ClinicalTrials.gov Identifier: NCT01092806     History of Changes
Other Study ID Numbers: ADVA-09
Study First Received: March 23, 2010
Last Updated: October 21, 2010
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by University of Oslo School of Pharmacy:
tacrolimus
pharmacokinetics
formulations
once daily
twice daily
renal transplant recipients
Kidney transplantation

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014