Kidney TransplantationPhase 3RESTORENCT00296361
To Compare the Efficacy and Safety of a Therapy of Tacrolimus With Sirolimus or MMF in Kidney Transplantation.
A Phase 3 study testing Tacrolimus in people with Kidney Transplantation, run by Astellas Pharma Inc at 59 sites in 14 countries.
Trial summary
Primary objective of this study is to compare the two therapy regimens with regard to renal function by using calculated creatinine clearance. The secondary objectives are to compare the efficacy and safety profiles of the two therapy regimens. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- 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
- 634 participants
- Where
- 59 sitesin 14 countries
- Study dates
- Oct 2004to Jul 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients between 18 and 60 years of age and having end stage kidney disease who will undergo 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 AB0 blood type can be included.
Who cannot join
- Patient has a high immunological risk
- Cold ischemia time greater than 30 hours
- Patient has significant liver disease
- Patient has severe hypercholesterolaemia
- Patient is allergic or intolerant to study medication
- Patient requires ongoing dosing with corticosteroids.
- Patient or donor is known to be HIV positive
- Patient with malignancy or history of malignancy
Trial locations and contacts
59 sites in 14 countries.
59 sites in 14 countries
Spain15 sites
Study site
Alicante, 03010
Study site
Badalona-Barcelona, 08916
Study site
Barcelona, 08035
Study site
Barcelona, 08036
Study site
Cadiz, 11009
Study site
Córdoba, 14004
Study site
Madrid, 28007
Study site
Madrid, 28046
Study site
Málaga, 29010
Study site
Palma de Mallorca, 07014
Study site
Santander, 39008
Study site
Santiago de Compostela, 15706
Study site
Valencia, 46009
Study site
Valencia, 46017
Study site
Valladolid, 47011
Germany12 sites
Study site
Aachen, 52074
Study site
Bochum, 44892
Study site
Cologne, 50931
Study site
Cologne, 51109
Study site
Freiburg im Breisgau, 79106
Study site
Halle, 06120
Study site
Hamburg, 20246
Study site
Hannoversch Münden, 34346
Study site
Hanover, 30625
Study site
Münster, 48149
Study site
Regensburg, 93042
Study site
Rostock, 18057
France8 sites
Study site
Amiens, 80480
Study site
Brest, 29200
Study site
Dijon, 21079
Study site
Limoges, 87042
Study site
Paris, 75018
Study site
Paris, 75475
Study site
Paris, 75970
Study site
Toulouse, 31059
Poland6 sites
Study site
Gdansk, 80-211
Study site
Krakow, 31-501
Study site
Poznan, 60-479
Study site
Szczecin, 71-455
Study site
Warsaw, 02-507
Study site
Wroclaw, 50-417
Austria3 sites
Study site
Linz, 4015
Study site
Linz, 4020
Study site
Vienna, 1090
Belgium3 sites
Study site
Brussels, 1090
Study site
Brussels, 1200
Study site
Leuven, 3000
United Kingdom2 sites
Study site
London, E1 1BB
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 Therapy of Tacrolimus With Sirolimus Versus Tacrolimus With Mycophenolate Mofetil in Kidney Transplantation.
Primary objective of this study is to compare the two therapy regimens with regard to renal function by using calculated creatinine clearance. The secondary objectives are to compare the efficacy and safety profiles of the two therapy regimens.
Read the detailed description
This phase III study shall provide detailed efficacy and safety information to compare this combination of sirolimus and tacrolimus with the current standard tacrolimus combination regimen (tacrolimus/MMF/steroids) which is widely used in European centres.
- 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
Also called Prograf, FK506
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 as assessed by calculated creatinine clearance at month 6.
Measured: 6 months
Secondary outcomes (1)
Acute rejection: Incidence of and time to first 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 completionJul 2006
- Study completionJul 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
- 634 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Physician, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296361
- Sponsor's protocol ID
- FG-506-02-40
- Acronym
- RESTORE
- 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 Therapy of Tacrolimus With Sirolimus Versus Tacrolimus With Mycophenolate Mofetil in Kidney Transplantation.
- ClinicalTrials.gov ID
- NCT00296361
- Acronym / sponsor ID
- RESTORE / FG-506-02-40
- Conditions
- Kidney Transplantation
- Keywords
- Tacrolimus, Kidney Transplantation, Immunosuppression, Adult, Treatment Outcomes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 634 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 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 two therapy regimens with regard to renal function by using calculated creatinine clearance. The secondary objectives are to compare the efficacy and safety profiles of the two therapy regimens.
Detailed description
This phase III study shall provide detailed efficacy and safety information to compare this combination of sirolimus and tacrolimus with the current standard tacrolimus combination regimen (tacrolimus/MMF/steroids) which is widely used in European centres.
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
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients between 18 and 60 years of age and having end stage kidney disease who will undergo 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 AB0 blood type can be included.
Key exclusion criteria (8 listed)
- Patient has a high immunological risk
- Cold ischemia time greater than 30 hours
- Patient has significant liver disease
- Patient has severe hypercholesterolaemia
- Patient is allergic or intolerant to study medication
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 |
Primary outcome
Renal function as assessed by calculated creatinine clearance at month 6.
Time frame: 6 months
1 secondary outcome
Acute rejection: Incidence of and time to first 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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RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
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
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
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.
59 sites in 14 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 59 sites in 14 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 8 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 59 sites in Spain, Germany, France, Poland, Austria and 9 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 as assessed by calculated creatinine clearance at month 6. (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.