To Compare the Efficacy and Safety of a Therapy of Tacrolimus With Sirolimus or MMF in Kidney Transplantation. - Full Text View

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00296361

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 III

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Tacrolimus Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Sirolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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.

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
1: Active Comparator	Drug: Tacrolimus immunosuppression
2: Experimental	Drug: Tacrolimus immunosuppression

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

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

More Information

Link to FDA Website This link exits the ClinicalTrials.gov site

Link to results on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

Responsible Party:	Astellas Pharma Europe BV ( Disclosure Office Europe )
Study ID Numbers:	FG-506-02-40
Study First Received:	February 23, 2006
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00296361
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Astellas Pharma Inc:

Tacrolimus
Kidney Transplantation
Immunosuppression
Adult
Treatment Outcomes

Study placed in the following topic categories:

Sirolimus
Mycophenolate mofetil
Tacrolimus

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009