NCT00296309

Brief Summary

Primary objective of this study is to compare the renal function as well as the incidence of renal dysfunction, the incidence of death, graft loss and acute rejection. Secondary Objective is to compare the efficacy and safety profiles of the two regimens in elderly renal transplanted patients.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
267

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2004

Geographic Reach
7 countries

33 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, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

September 1, 2014

Status Verified

August 1, 2014

Enrollment Period

1.8 years

First QC Date

February 23, 2006

Last Update Submit

August 28, 2014

Conditions

Kidney Transplantation

Keywords

TacrolimusKidney TransplantationImmunosuppressionAdultTreatment Outcomes

Outcome Measures

Primary Outcomes (1)

  • Renal function measured by creatinine clearance

    6 months

Secondary Outcomes (1)

  • Acute rejection

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Tacrolimus

2

EXPERIMENTAL
Drug: Tacrolimus

Interventions

TacrolimusDRUG

Immunosuppression

12

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with minimum 60 years of age and end stage kidney disease who are suitable candidates for primary renal transplantation or retransplantation are eligible for the study. Patients receiving a kidney transplant, from a cadaveric or living donor (not HLA identical) with compatible ABO blood type can be included.

You may not qualify if:

  • Patient has an immunological high risk
  • Cold ischemia time greater than 30 hours.
  • Patient has significant liver disease
  • Patient is allergic or intolerant to study medication
  • Patient or donor is known to be HIV positive.
  • Patient with malignancy or history of malignancy
  • Patient has significant, uncontrolled concomitant infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Unknown Facility

Brussels, 1200, Belgium

Location

Unknown Facility

Leuven, 3000, Belgium

Location

Unknown Facility

Bordeaux, 33076, France

Location

Unknown Facility

Clermont-Ferrand, 63003, France

Location

Unknown Facility

Créteil, 94010, France

Location

Unknown Facility

Le Kremlin-Bicêtre, 94275, France

Location

Unknown Facility

Montpellier, 34295, France

Location

Unknown Facility

Nice, 06002, France

Location

Unknown Facility

Suresnes, 92151, France

Location

Unknown Facility

Toulouse, 31059, France

Location

Unknown Facility

Tours, 37044, France

Location

Unknown Facility

Vandœuvre-lès-Nancy, 54511, France

Location

Unknown Facility

Berlin, 10117, Germany

Location

Unknown Facility

Cologne, 50931, Germany

Location

Unknown Facility

Cologne, 51109, Germany

Location

Unknown Facility

Essen, 45122, Germany

Location

Unknown Facility

Freiberg, 79106, Germany

Location

Unknown Facility

Halle, 06120, Germany

Location

Unknown Facility

Hanover, 30625, Germany

Location

Unknown Facility

Jena, 07747, Germany

Location

Unknown Facility

Leipzig, 04103, Germany

Location

Unknown Facility

Lübeck, 23562, Germany

Location

Unknown Facility

München, 81675, Germany

Location

Unknown Facility

Münster, 48149, Germany

Location

Unknown Facility

Rostock, 18057, Germany

Location

Unknown Facility

Utrecht, 3508, Netherlands

Location

Unknown Facility

Madrid, 28007, Spain

Location

Unknown Facility

Madrid, 28041, Spain

Location

Unknown Facility

Santander, 39008, Spain

Location

Unknown Facility

Zurich, 8091, Switzerland

Location

Unknown Facility

Belfast, BT9 7AB, United Kingdom

Location

Unknown Facility

Cambridge, CB2 2QQ, United Kingdom

Location

Unknown Facility

Nottingham, NG5 1PB, United Kingdom

Location

Related Links

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Medical Physician

    Astellas Pharma Europe B.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2006

First Posted

February 27, 2006

Study Start

October 1, 2004

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

September 1, 2014

Record last verified: 2014-08

Locations

GB(3)NL(1)BE(2)ES(3)CH(1)DE(13)FR(10)