KIDNEY TRANSPLANTATIONPhase 3TIGRENCT00321113
Comparison of Two Tacrolimus Based Immunosuppressive Regimens in Recipients Receiving Marginal Donor Kidneys
A Phase 3 study testing tacrolimus, mycophenolate mofetil and steroids in people with KIDNEY TRANSPLANTATION, run by Astellas Pharma Inc at 14 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- KIDNEY TRANSPLANTATION
- What is being tested?
- tacrolimus, mycophenolate mofetil and steroids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 14 sitesItaly
- Study dates
- Sep 2004to Mar 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Italy14 sites
Study site
Bologna, 40138
Study site
Cagliari, 09134
Study site
Milan, 30100
Study site
Modena, 41100
Study site
Padova, 35128
Study site
Palermo, 90127
Study site
Roma, 00144
Study site
Roma, 00161
Study site
Roma, 00168
Study site
Sassari, 35128
Study site
Siena, 53100
Study site
Treviso
Study site
Udine
Study site
Vicenza, 36100
About this study
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
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.
Read the 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)
- Conditions
- KIDNEY TRANSPLANTATION
- Being tested
- tacrolimus, mycophenolate mofetil, steroids
- Keywords
- MARGINAL KIDNEY, TACROLIMUS, IMMUNOSUPPRESSION, ELDERLY RECEPIENTS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimusDrug
Also called Prograf, FK506
immunosuppression
Also called MMF
oral
steroidsDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | oral Receives: Drug: tacrolimus; Drug: mycophenolate mofetil |
| 2 | Experimental | oral Receives: Drug: tacrolimus; Drug: mycophenolate mofetil; Drug: steroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculated creatinine clearance
Measured: 6 months
Secondary outcomes (1)
Acute Rejection, patient survival, graft survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startSep 2004
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KIDNEY TRANSPLANTATIONStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00321113
- Sponsor's protocol ID
- FG-506-02-IT-01
- Acronym
- TIGRE
- Status last verified
- Feb 2017
- First submitted
- 1 May 2006
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00321113
- Acronym / sponsor ID
- TIGRE / FG-506-02-IT-01
- Conditions
- KIDNEY TRANSPLANTATION
- Keywords
- MARGINAL KIDNEY, TACROLIMUS, IMMUNOSUPPRESSION, ELDERLY RECEPIENTS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 3 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: tacrolimus, Drug: mycophenolate mofetiloral |
| 2 | Experimental | Drug: tacrolimus, Drug: mycophenolate mofetil, Drug: steroidsoral |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tacrolimusAlso: Prograf, FK506immunosuppression | Drug | 1, 2 |
| mycophenolate mofetilAlso: MMForal | Drug | 1, 2 |
| steroidsoral | Drug | 2 |
Primary outcome
Calculated creatinine clearance
Time frame: 6 months
1 secondary outcome
Acute Rejection, patient survival, graft survival
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Europe B.V.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tacrolimus, mycophenolate mofetil and steroids in people with KIDNEY TRANSPLANTATION, run by Astellas Pharma Inc at 14 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculated creatinine clearance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017.