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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00296361
First received: February 23, 2006
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Kidney Transplantation
Drug: Tacrolimus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Renal function as assessed by calculated creatinine clearance at month 6. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute rejection: Incidence of and time to first acute rejection [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 634
Study Start Date: October 2004
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Tacrolimus
immunosuppression
Other Name: Prograf, FK506
Experimental: 2 Drug: Tacrolimus
immunosuppression
Other Name: Prograf, FK506

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296361

  Show 59 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Physician Astellas Pharma Europe B.V.
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00296361     History of Changes
Other Study ID Numbers: FG-506-02-40
Study First Received: February 23, 2006
Last Updated: August 28, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Astellas Pharma Inc:
Tacrolimus
Kidney Transplantation
Immunosuppression
Adult
Treatment Outcomes

Additional relevant MeSH terms:
Tacrolimus
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014