To Compare the Efficacy and Safety of a Therapy of Tacrolimus With Sirolimus or MMF in Kidney Transplantation.
RESTORE
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.
1 other identifier
interventional
634
13 countries
56
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2004
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 23, 2006
CompletedFirst Posted
Study publicly available on registry
February 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedSeptember 1, 2014
August 1, 2014
1.7 years
February 23, 2006
August 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Renal function as assessed by calculated creatinine clearance at month 6.
6 months
Secondary Outcomes (1)
Acute rejection: Incidence of and time to first acute rejection
6 months
Study Arms (2)
1
ACTIVE COMPARATOR2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (59)
Unknown Facility
Nedlands, Australia
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Perth, Australia
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Linz, 4015, Austria
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Linz, 4020, Austria
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Vienna, 1090, Austria
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Brussels, 1090, Belgium
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Brussels, 1200, Belgium
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Leuven, 3000, Belgium
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Olomouc, 775 00, Czechia
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Ostrava, 70852, Czechia
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Amiens, 80480, France
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Brest, 29200, France
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Dijon, 21079, France
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Limoges, 87042, France
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Paris, 75018, France
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Paris, 75475, France
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Paris, 75970, France
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Toulouse, 31059, France
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Aachen, 52074, Germany
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Bochum, 44892, Germany
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Cologne, 50931, Germany
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Cologne, 51109, Germany
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Freiburg im Breisgau, 79106, Germany
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Halle, 06120, Germany
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Hamburg, 20246, Germany
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Hannoversch Münden, 34346, Germany
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Hanover, 30625, Germany
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Münster, 48149, Germany
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Regensburg, 93042, Germany
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Rostock, 18057, Germany
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Debrecen, 4012, Hungary
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Milan, 20132, Italy
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Napoli, 80131, Italy
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Rotterdam, 3015 GD, Netherlands
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Gdansk, 80-211, Poland
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Krakow, 31-501, Poland
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Poznan, 60-479, Poland
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Szczecin, 71-455, Poland
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Warsaw, 02-507, Poland
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Wroclaw, 50-417, Poland
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Bucharest, 022328, Romania
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Alicante, 03010, Spain
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Badalona-Barcelona, 08916, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Cadiz, 11009, Spain
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Córdoba, 14004, Spain
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Madrid, 28007, Spain
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Madrid, 28046, Spain
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Málaga, 29010, Spain
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Palma de Mallorca, 07014, Spain
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Santander, 39008, Spain
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Santiago de Compostela, 15706, Spain
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Valencia, 46009, Spain
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Valencia, 46017, Spain
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Valladolid, 47011, Spain
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Gothenburg, 41345, Sweden
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London, E1 1BB, United Kingdom
Unknown Facility
Nottingham, NG5 1PB, United Kingdom
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Physician
Astellas Pharma Europe B.V.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2006
First Posted
February 27, 2006
Study Start
October 1, 2004
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
September 1, 2014
Record last verified: 2014-08