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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00321113
Other study ID # FG-506-02-IT-01
Secondary ID
Status Completed
Phase Phase 3
First received May 1, 2006
Last updated February 22, 2017
Start date September 2004
Est. completion date March 2008

Study information

Verified date February 2017
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

An open, multicentre, randomized, parallel group study to compare in marginal old-for-old renal transplant patients the safety and efficacy of two treatments: sequential mycophenolate mofetil/delayed tacrolimus plus steroids vs tacrolimus plus mycophenolate mofetil, in patients requiring induction with anti-IL2 monoclonal antibody.

Elderly (≥50 years) low risk patients (PRA grade ≤50%, in the previous 6 months) receiving an allograft transplantation of marginal kidney(s) from elderly (>65 years) donors (old-for-old allocation) will be randomized to one of the following treatment arms:

Arm1: Sequential mycophenolate mofetil/tacrolimus/steroids

Arm2: Tacrolimus/mycophenolate mofetil/steroid one single dose (perioperatively)


Recruitment information / eligibility

Status Completed
Enrollment 142
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Other exclusion criteria apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
tacrolimus
immunosuppression
mycophenolate mofetil
oral
steroids
oral

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Calculated creatinine clearance 6 months
Secondary Acute Rejection, patient survival, graft survival 6 months
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