To Compare the Efficacy and Safety of a Therapy of Tacrolimus With Sirolimus or MMF in Kidney Transplantation. (RESTORE)

August 28, 2014 updated by: Astellas Pharma Inc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

634

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Nedlands, Australia
      • Perth, Australia
  • Austria
      • Linz, Austria, 4020
      • Linz, Austria, 4015
      • Wien, Austria, 1090
  • Belgium
      • Brussels, Belgium, 1090
      • Bruxelles, Belgium, 1200
      • Leuven, Belgium, 3000
  • Czech Republic
      • Olomouc, Czech Republic, 775 00
      • Ostrava, Czech Republic, 70852
  • France
      • Amiens, France, 80480
      • Brest, France, 29200
      • Dijon, France, 21079
      • Limoges, France, 87042
      • Paris, France, 75018
      • Paris, France, 75970
      • Paris, France, 75475
      • Toulouse, France, 31059
  • Germany
      • Aachen, Germany, 52074
      • Bochum, Germany, 44892
      • Freiburg, Germany, 79106
      • Halle, Germany, 06120
      • Hamburg, Germany, 20246
      • Hann. Münden, Germany, 34346
      • Hannover, Germany, 30625
      • Koln, Germany, 50931
      • Koln, Germany, 51109
      • Munster, Germany, 48149
      • Regensburg, Germany, 93042
      • Rostock, Germany, 18057
  • Hungary
      • Debrecen, Hungary, 4012
  • Italy
      • Milano, Italy, 20132
      • Napoli, Italy, 80131
  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
  • Poland
      • Gdansk, Poland, 80-211
      • Krakow, Poland, 31-501
      • Poznan, Poland, 60-479
      • Szczecin, Poland, 71-455
      • Warszawa, Poland, 02-507
      • Wroclaw, Poland, 50-417
  • Romania
      • Bucharest, Romania, 022328
  • Spain
      • Alicante, Spain, 03010
      • Badalona-Barcelona, Spain, 08916
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08035
      • Cadiz, Spain, 11009
      • Cordoba, Spain, 14004
      • Madrid, Spain, 28046
      • Madrid, Spain, 28007
      • Malaga, Spain, 29010
      • Palma de Mallorca, Spain, 07014
      • Santander, Spain, 39008
      • Santiago de Compostela, Spain, 15706
      • Valencia, Spain, 46017
      • Valencia, Spain, 46009
      • Valladolid, Spain, 47011
  • Sweden
      • Goteborg, Sweden, 41345
  • United Kingdom
      • London, United Kingdom, E1 1BB
      • Nottingham, United Kingdom, NG5 1PB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Drug: Tacrolimus
immunosuppression
Other Names:
  • Prograf, FK506
Active Comparator: 1
Drug: Tacrolimus
immunosuppression
Other Names:
  • Prograf, FK506

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Renal function as assessed by calculated creatinine clearance at month 6.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Acute rejection: Incidence of and time to first acute rejection
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Investigators

  • Study Director: Medical Physician, Astellas Pharma Europe B.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

February 23, 2006

First Submitted That Met QC Criteria

February 23, 2006

First Posted (Estimate)

February 27, 2006

Study Record Updates

Last Update Posted (Estimate)

September 1, 2014

Last Update Submitted That Met QC Criteria

August 28, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FG-506-02-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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