NCT00321113

Brief Summary

The purpose of this study is to explore the safety and efficacy of two different immunosuppressive regimens (sequential tacrolimus/mycophenolate mofetil \[MMF\] plus steroids versus tacrolimus plus MMF, following induction with daclizumab) in recipients of marginal donor kidneys.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2004

Typical duration for phase_3

Geographic Reach
1 country

14 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

September 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

3.5 years

First QC Date

May 1, 2006

Last Update Submit

February 22, 2017

Conditions

KIDNEY TRANSPLANTATION

Keywords

MARGINAL KIDNEYTACROLIMUSIMMUNOSUPPRESSIONELDERLY RECEPIENTS

Outcome Measures

Primary Outcomes (1)

  • Calculated creatinine clearance

    6 months

Secondary Outcomes (1)

  • Acute Rejection, patient survival, graft survival

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR

oral

Drug: tacrolimusDrug: mycophenolate mofetil

2

EXPERIMENTAL

oral

Drug: tacrolimusDrug: mycophenolate mofetilDrug: steroids

Interventions

tacrolimusDRUG

immunosuppression

Also known as: Prograf, FK506
12
mycophenolate mofetilDRUG

oral

Also known as: MMF
12
steroidsDRUG

oral

2

Eligibility Criteria

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

You may qualify if:

  • Male or female patients minimum 60 years of age undergoing a cadaveric kidney transplant
  • Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation.
  • Donors older than 60 years
  • Female patients of child bearing age agree to practice effective birth control during the study.
  • Patient has been fully informed and has given written informed consent

You may not qualify if:

  • Patient has significant, uncontrolled, concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer
  • Patient has previously received or is receiving an organ transplant other than kidney or a kidney retransplant
  • Any pathology or medical condition that can interfere with this protocol study proposal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Bologna, 40138, Italy

Location

Unknown Facility

Cagliari, 09134, Italy

Location

Unknown Facility

Milan, 30100, Italy

Location

Unknown Facility

Modena, 41100, Italy

Location

Unknown Facility

Padua, 35128, Italy

Location

Unknown Facility

Palermo, 90127, Italy

Location

Unknown Facility

Roma, 00144, Italy

Location

Unknown Facility

Roma, 00161, Italy

Location

Unknown Facility

Roma, 00168, Italy

Location

Unknown Facility

Sassari, 35128, Italy

Location

Unknown Facility

Siena, 53100, Italy

Location

Unknown Facility

Treviso, Italy

Location

Unknown Facility

Udine, Italy

Location

Unknown Facility

Vicenza, 36100, Italy

Location

Related Links

MeSH Terms

Interventions

TacrolimusMycophenolic AcidSteroids

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Medical Director

    Astellas Pharma Europe B.V.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 1, 2006

First Posted

May 3, 2006

Study Start

September 1, 2004

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

IT(14)