NCT01332201

Brief Summary

Comparison of tacrolimus blood levels in adults who have received a transplant and are taking either Prograf or Advagraf anti-rejection therapy immediately following surgery. This is followed by checking of safety and effectiveness for one year.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2011

Geographic Reach
6 countries

8 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

June 16, 2015

Status Verified

June 1, 2015

Enrollment Period

2.3 years

First QC Date

April 7, 2011

Last Update Submit

June 12, 2015

Conditions

Heart TransplantationLung TransplantationPancreas (Including SPK) Transplantation

Keywords

AdvagrafHeartLungPancreasTransplantImmunosuppressionPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • determine steady state systemic exposure (AUC 0-24h)

    Day 1, Day 3, Day 7 and Day 42

Secondary Outcomes (6)

  • determine Cmax (maximum concentration)

    Day 1, Day 3, Day 7 and Day 42

  • determine tmax (time to attain Cmax)

    Day 1, Day 3, Day 7 and Day 42

  • determine C24 (concentration prior to next morning dose)

    Day 1, Day 3, Day 7 and Day 42

  • describe rejection episodes

    up to 58 weeks

  • describe subject survival

    up to 58 weeks

  • +1 more secondary outcomes

Study Arms (2)

Advagraf

EXPERIMENTAL
Drug: Advagraf

Prograf

ACTIVE COMPARATOR
Drug: Prograf

Interventions

AdvagrafDRUG

oral

Also known as: FK506E, MR4, tacrolimus modified release
Advagraf
PrografDRUG

oral

Also known as: tacrolimus, FK506
Prograf

Eligibility Criteria

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

You may qualify if:

  • must receive first oral dose of tacrolimus one day (lung, pancreas or Simultaneous Pancreas Kidney (SPK) recipients) or three days (heart recipients) after transplantation (skin closure)
  • negative pregnancy test prior to enrolment (females)
  • agree to practice effective birth control during the study
  • treated since transplantation with Antithymocyte globulin/ Mycophenolate Mofetil/steroids (ATG/MMF/steroids), gastric motility resumed and renal function adequate (\<230 µmol/l (\<2.6 ml/dl)) on Day 1

You may not qualify if:

  • receiving a multi-organ transplant (with the exception of SPK) or previously received an organ transplant (including re-transplantation)
  • pulmonary vascular resistance ≥4 Wood units despite medication
  • required an emergency ventricular assist device within one week prior to transplantation
  • significant renal impairment
  • significant liver disease
  • malignancies or a history of malignancy within the last 5 years
  • significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastrointestinal disorder that may affect the absorption of tacrolimus, or active peptic ulcer
  • requires systemic immunosuppressive medication for any other indication than transplantation
  • diagnosis of cystic fibrosis
  • pregnant or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Vienna, Austria

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Milan, Italy

Location

Unknown Facility

Padua, Italy

Location

Unknown Facility

Taipei, Taiwan

Location

Unknown Facility

London, United Kingdom

Location

Unknown Facility

Manchester, United Kingdom

Location

Related Links

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Use Central Contact

    Astellas Pharma Europe Ltd.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2011

First Posted

April 11, 2011

Study Start

July 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

June 16, 2015

Record last verified: 2015-06

Locations

BE(1)FR(1)AU(1)TW(1)GB(2)IT(2)