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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00321113
First received: May 1, 2006
Last updated: April 7, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation
Drug: tacrolimus
Drug: mycophenolate mofetil
Drug: steroids
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Calculated creatinine clearance [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute Rejection, patient survival, graft survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 142
Study Start Date: September 2004
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: tacrolimus
immunosuppression
Other Names:
  • Prograf
  • FK506
Drug: mycophenolate mofetil
oral
Other Name: MMF
Experimental: 2 Drug: tacrolimus
immunosuppression
Other Names:
  • Prograf
  • FK506
Drug: mycophenolate mofetil
oral
Other Name: MMF
Drug: steroids
oral

Detailed 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)

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00321113

Locations
Italy
Bologna, Italy, 40138
Cagliari, Italy, 09134
Milano, Italy, 30100
Modena, Italy, 41100
Padova, Italy, 35128
Palermo, Italy, 90127
Roma, Italy, 00161
Roma, Italy, 00168
Roma, Italy, 00144
Sassari, Italy, 35128
Siena, Italy, 53100
Treviso, Italy
Udine, Italy
Vicenza, Italy, 36100
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Europe BV
  More Information

Additional Information:
No publications provided

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT00321113     History of Changes
Other Study ID Numbers: FG-506-02-IT-01
Study First Received: May 1, 2006
Last Updated: April 7, 2009
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Astellas Pharma Inc:
IMMUNOSUPPRESSION
TACROLIMUS
ELDERLY RECEPIENTS
MARGINAL KIDNEY

Additional relevant MeSH terms:
Mycophenolate mofetil
Tacrolimus
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014