NCT01092806

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

7 months

First QC Date

March 23, 2010

Last Update Submit

December 2, 2014

Conditions

Post Transplant Diabetes Mellitus

Keywords

tacrolimuspharmacokineticsformulationsonce dailytwice dailyrenal transplant recipientsKidney transplantation

Outcome Measures

Primary Outcomes (1)

  • The primary objective is to compare insulin secretion (Secr2.phase) between the two different formulations of Tac.

    Insulin secretion is investigated by hyperglycemic clamp

    1 month

Secondary Outcomes (2)

  • Secondary objectives are to compare the effect of the two formulations on Secr1.phase,

    1 month

  • insulin sensitivity

    1 month

Study Arms (2)

Prograf

ACTIVE COMPARATOR

Patients are treated until steady-state conditions with Prograf and then investigated with clamp

Drug: Tacrolimus

Advagraf

EXPERIMENTAL

The patients are treated with Advagraf until steady-state conditions and then investigated with clamp

Drug: Tacrolimus

Interventions

TacrolimusDRUG

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.

Also known as: Prograf (BID formulation), Advagraf (QD formulation)
AdvagrafPrograf

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Renal transplant recipients on stable Tac based immunosuppressive therapy.
  • years of age or older.
  • Stable prednisolone dose of 5 mg/day or less.
  • S-creatinine below 150 umol/L.
  • Signed informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo univeristy hospital, Rikshospitalet

Oslo, 0027, Norway

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Karsten Midtvedt, MD, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study leader

Study Record Dates

First Submitted

March 23, 2010

First Posted

March 25, 2010

Study Start

October 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

NO(1)