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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00296361




Registration number
NCT00296361
Ethics application status
Date submitted
23/02/2006
Date registered
27/02/2006
Date last updated
1/09/2014

Titles & IDs
Public title
To Compare the Efficacy and Safety of a Therapy of Tacrolimus With Sirolimus or MMF in Kidney Transplantation.
Scientific 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.
Secondary ID [1] 0 0
FG-506-02-40
Universal Trial Number (UTN)
Trial acronym
RESTORE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Transplantation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tacrolimus

Active Comparator: 1 -

Experimental: 2 -


Treatment: Drugs: Tacrolimus
immunosuppression
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Renal function as assessed by calculated creatinine clearance at month 6.
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Acute rejection: Incidence of and time to first acute rejection
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
- 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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2006
Sample size
Target
Accrual to date
Final
634
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Nedlands
Recruitment hospital [2] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
- Nedlands
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Linz
Country [2] 0 0
Austria
State/province [2] 0 0
Wien
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussels
Country [4] 0 0
Belgium
State/province [4] 0 0
Bruxelles
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Olomouc
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Ostrava
Country [8] 0 0
France
State/province [8] 0 0
Amiens
Country [9] 0 0
France
State/province [9] 0 0
Brest
Country [10] 0 0
France
State/province [10] 0 0
Dijon
Country [11] 0 0
France
State/province [11] 0 0
Limoges
Country [12] 0 0
France
State/province [12] 0 0
Paris
Country [13] 0 0
France
State/province [13] 0 0
Toulouse
Country [14] 0 0
Germany
State/province [14] 0 0
Aachen
Country [15] 0 0
Germany
State/province [15] 0 0
Bochum
Country [16] 0 0
Germany
State/province [16] 0 0
Freiburg
Country [17] 0 0
Germany
State/province [17] 0 0
Halle
Country [18] 0 0
Germany
State/province [18] 0 0
Hamburg
Country [19] 0 0
Germany
State/province [19] 0 0
Hann. Münden
Country [20] 0 0
Germany
State/province [20] 0 0
Hannover
Country [21] 0 0
Germany
State/province [21] 0 0
Koln
Country [22] 0 0
Germany
State/province [22] 0 0
Munster
Country [23] 0 0
Germany
State/province [23] 0 0
Regensburg
Country [24] 0 0
Germany
State/province [24] 0 0
Rostock
Country [25] 0 0
Hungary
State/province [25] 0 0
Debrecen
Country [26] 0 0
Italy
State/province [26] 0 0
Milano
Country [27] 0 0
Italy
State/province [27] 0 0
Napoli
Country [28] 0 0
Netherlands
State/province [28] 0 0
Rotterdam
Country [29] 0 0
Poland
State/province [29] 0 0
Gdansk
Country [30] 0 0
Poland
State/province [30] 0 0
Krakow
Country [31] 0 0
Poland
State/province [31] 0 0
Poznan
Country [32] 0 0
Poland
State/province [32] 0 0
Szczecin
Country [33] 0 0
Poland
State/province [33] 0 0
Warszawa
Country [34] 0 0
Poland
State/province [34] 0 0
Wroclaw
Country [35] 0 0
Romania
State/province [35] 0 0
Bucharest
Country [36] 0 0
Spain
State/province [36] 0 0
Alicante
Country [37] 0 0
Spain
State/province [37] 0 0
Badalona-Barcelona
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Spain
State/province [39] 0 0
Cadiz
Country [40] 0 0
Spain
State/province [40] 0 0
Cordoba
Country [41] 0 0
Spain
State/province [41] 0 0
Madrid
Country [42] 0 0
Spain
State/province [42] 0 0
Malaga
Country [43] 0 0
Spain
State/province [43] 0 0
Palma de Mallorca
Country [44] 0 0
Spain
State/province [44] 0 0
Santander
Country [45] 0 0
Spain
State/province [45] 0 0
Santiago de Compostela
Country [46] 0 0
Spain
State/province [46] 0 0
Valencia
Country [47] 0 0
Spain
State/province [47] 0 0
Valladolid
Country [48] 0 0
Sweden
State/province [48] 0 0
Goteborg
Country [49] 0 0
United Kingdom
State/province [49] 0 0
London
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Astellas Pharma Inc
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00296361
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Physician
Address 0 0
Astellas Pharma Europe B.V.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries