NCT00384137

Brief Summary

Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based immunosuppressive regimen in stable kidney transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive regimen.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_3

Geographic Reach
6 countries

13 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

Study Start

First participant enrolled

October 1, 2006

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

July 9, 2014

Status Verified

July 1, 2014

Enrollment Period

9 months

First QC Date

October 4, 2006

Last Update Submit

July 7, 2014

Conditions

Transplantation

Keywords

TacrolimusKidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • Creatinine clearance

    12 weeks

Secondary Outcomes (1)

  • Blood pressure, HbA1c, acute rejection

    12 weeks

Study Arms (1)

1

EXPERIMENTAL
Drug: Tacrolimus

Interventions

TacrolimusDRUG

Immunosuppression

Also known as: FK506E, MR4
1

Eligibility Criteria

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

You may qualify if:

  • Kidney transplant at least 12 months prior to enrollment.
  • Prograf® dose remained unchanged for a minimum of 12 weeks prior to enrollment and tacrolimus whole blood trough level measurements were in the range of 5-15 ng/mL.

You may not qualify if:

  • Any unstable medical condition that could interfere with the study objectives in the opinion of the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Bicêtre, 94275, France

Location

Unknown Facility

Freiburg im Breisgau, 79106, Germany

Location

Unknown Facility

Regensburg, 93053, Germany

Location

Unknown Facility

Maastricht, 6229, Netherlands

Location

Unknown Facility

Rotterdam, 3015 GD, Netherlands

Location

Unknown Facility

Poznan, 60-479, Poland

Location

Unknown Facility

Szczecin, 70-111, Poland

Location

Unknown Facility

Barcelona, 08025, Spain

Location

Unknown Facility

Barcelona, 08036, Spain

Location

Unknown Facility

Barcelona, 08916, Spain

Location

Unknown Facility

Madrid, 28034, Spain

Location

Unknown Facility

Madrid, 28041, Spain

Location

Unknown Facility

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Use Central Contact

    Astellas Pharma GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 4, 2006

First Posted

October 5, 2006

Study Start

October 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

July 9, 2014

Record last verified: 2014-07

Locations

NL(2)GB(1)FR(1)ES(5)DE(2)PL(2)