Comparison of Two Tacrolimus Based Immunosuppressive Regimens in Recipients Receiving Marginal Donor Kidneys

KIDNEY TRANSPLANTATION Clinical Trial

— TIGRE  

Official title:

An Open, Multicentre, Randomised, 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 Antibody

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00321113
• Other study ID #: FG-506-02-IT-01
• 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
• 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

Related Conditions & MeSH terms

• KIDNEY TRANSPLANTATION

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

External Links

•   Link to results on Astellas Clinical Study Results website