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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00296361
Recruitment Status : Completed
First Posted : February 27, 2006
Last Update Posted : September 1, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: Tacrolimus Phase 3

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  (Clinical Trial)
Actual Enrollment : 634 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Study Start Date : October 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Drug: Tacrolimus
Other Name: Prograf, FK506
Experimental: 2 Drug: Tacrolimus
Other Name: Prograf, FK506

Primary Outcome Measures :
  1. Renal function as assessed by calculated creatinine clearance at month 6. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Acute rejection: Incidence of and time to first acute rejection [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00296361

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Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Medical Physician Astellas Pharma Europe B.V.

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00296361     History of Changes
Other Study ID Numbers: FG-506-02-40
First Posted: February 27, 2006    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014

Keywords provided by Astellas Pharma Inc:
Kidney Transplantation
Treatment Outcomes

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents