Kidney TransplantationPhase 3SENIORNCT00296309
Comparing Efficacy & Safety of Tacrolimus & MMF With/Without Induction in the Elderly Following Kidney Transplantation.
A Phase 3 study testing Tacrolimus in people with Kidney Transplantation, run by Astellas Pharma Inc at 33 sites in 7 countries.
Trial summary
Primary objective of this study is to compare the renal function as well as the incidence of renal dysfunction, the incidence of death, graft loss and acute rejection. Secondary Objective is to compare the efficacy and safety profiles of the two regimens in elderly renal transplanted patients. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 33 sitesin 7 countries
- Study dates
- Oct 2004to Aug 2006
- 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
- Patients with minimum 60 years of age and end stage kidney disease who are suitable candidates for primary renal transplantation or retransplantation are eligible for the study. Patients receiving a kidney transplant, from a cadaveric or living donor (not HLA identical) with compatible ABO blood type can be included.
Who cannot join
- Patient has an immunological high risk
- Cold ischemia time greater than 30 hours.
- Patient has significant liver disease
- Patient is allergic or intolerant to study medication
- Patient or donor is known to be HIV positive.
- Patient with malignancy or history of malignancy
- Patient has significant, uncontrolled concomitant infections
Trial locations and contacts
33 sites in 7 countries.
33 sites in 7 countries
Germany13 sites
Study site
Berlin, 10117
Study site
Cologne, 50931
Study site
Cologne, 51109
Study site
Essen, 45122
Study site
Freiberg, 79106
Study site
Halle, 06120
Study site
Hanover, 30625
Study site
Jena, 07747
Study site
Leipzig, 04103
Study site
Lübeck, 23562
Study site
München, 81675
Study site
Münster, 48149
Study site
Rostock, 18057
France10 sites
Study site
Bordeaux, 33076
Study site
Clermont-Ferrand, 63003
Study site
Créteil, 94010
Study site
Le Kremlin-Bicêtre, 94275
Study site
Montpellier, 34295
Study site
Nice, 06002
Study site
Suresnes, 92151
Study site
Toulouse, 31059
Study site
Tours, 37044
Study site
Vandœuvre-lès-Nancy, 54511
Spain3 sites
Study site
Madrid, 28007
Study site
Madrid, 28041
Study site
Santander, 39008
United Kingdom3 sites
Study site
Belfast, BT9 7AB
Study site
Cambridge, CB2 2QQ
Study site
Nottingham, NG5 1PB
About this study
Official title: A Multicentre, Randomised, Open Clinical Study to Compare the Efficacy and Safety of a Combination of Tacrolimus and Mycophenolate Mofetil Based Regimen With or Without Induction in Elderly Recipients Undergoing Kidney Transplantation
Primary objective of this study is to compare the renal function as well as the incidence of renal dysfunction, the incidence of death, graft loss and acute rejection. Secondary Objective is to compare the efficacy and safety profiles of the two regimens in elderly renal transplanted patients.
Read the detailed description
The use of tacrolimus-based primary immunosuppression in elderly renal transplant recipients is efficacious and safe, particularly in combination with MMF, and seems to be associated with lower mortality and graft loss rates than classic cyclosporin protocols. Nevertheless, the efficacy and safety of tacrolimus in monotherapy, double or triple therapy with MMF, as well as the induction therapy with the new anti-IL2 receptor antibodies have not been adequately used in controlled trials in the elderly renal transplant patient. There is only scarce information on age-associated immune responsiveness and only a few aged-adapted immunosuppressive regimens have been described.
- Conditions
- Kidney Transplantation
- Being tested
- Tacrolimus
- Keywords
- Tacrolimus, Kidney Transplantation, Immunosuppression, Adult, Treatment Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Immunosuppression
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Tacrolimus |
| 2 | Experimental | Not described Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function measured by creatinine clearance
Measured: 6 months
Secondary outcomes (1)
Acute rejection
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 posted27 Feb 2006 (estimated)
- Study startOct 2004
- Primary completionAug 2006
- Study completionAug 2006
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Europe B.V.
- Responsible party
- Sponsor
- Investigators
- Medical Physician, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296309
- Sponsor's protocol ID
- FG-506-02-42
- Acronym
- SENIOR
- Status last verified
- Aug 2014
- First submitted
- 23 Feb 2006
- Last updated
- 1 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Open Clinical Study to Compare the Efficacy and Safety of a Combination of Tacrolimus and Mycophenolate Mofetil Based Regimen With or Without Induction in Elderly Recipients Undergoing Kidney Transplantation
- ClinicalTrials.gov ID
- NCT00296309
- Acronym / sponsor ID
- SENIOR / FG-506-02-42
- Conditions
- Kidney Transplantation
- Keywords
- Tacrolimus, Kidney Transplantation, Immunosuppression, Adult, Treatment Outcomes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Europe B.V.
- Study start
- Oct 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 27 Feb 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.
Primary objective of this study is to compare the renal function as well as the incidence of renal dysfunction, the incidence of death, graft loss and acute rejection. Secondary Objective is to compare the efficacy and safety profiles of the two regimens in elderly renal transplanted patients.
Detailed description
The use of tacrolimus-based primary immunosuppression in elderly renal transplant recipients is efficacious and safe, particularly in combination with MMF, and seems to be associated with lower mortality and graft loss rates than classic cyclosporin protocols. Nevertheless, the efficacy and safety of tacrolimus in monotherapy, double or triple therapy with MMF, as well as the induction therapy with the new anti-IL2 receptor antibodies have not been adequately used in controlled trials in the elderly renal transplant patient. There is only scarce information on age-associated immune responsiveness and only a few aged-adapted immunosuppressive regimens have been described.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Tacrolimus |
| 2 | Experimental | Drug: Tacrolimus |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with minimum 60 years of age and end stage kidney disease who are suitable candidates for primary renal transplantation or retransplantation are eligible for the study. Patients receiving a kidney transplant, from a cadaveric or living donor (not HLA identical) with compatible ABO blood type can be included.
Key exclusion criteria (7 listed)
- Patient has an immunological high risk
- Cold ischemia time greater than 30 hours.
- Patient has significant liver disease
- Patient is allergic or intolerant to study medication
- Patient or donor is known to be HIV positive.
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 |
|---|---|---|
| TacrolimusImmunosuppression | Drug | 1, 2 |
Primary outcome
Renal function measured by creatinine clearance
Time frame: 6 months
1 secondary outcome
Acute rejection
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 1 Sep 2014.
- Link to FDA WebsiteLink provided by the sponsor.
Related trials for Kidney Transplantation
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Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
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Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
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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 Physician study director
Astellas Pharma Europe B.V.
33 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tacrolimus in people with Kidney Transplantation, run by Astellas Pharma Inc at 33 sites in 7 countries.
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 1 inclusion and 7 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 1 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Germany, France, Spain, United Kingdom, Belgium and 2 more countries. 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?
Renal function measured by 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 1 Sep 2014.