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

Kidney Transplantation Clinical Trial

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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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296361
• Other study ID #: FG-506-02-40
• Status: Completed
• Phase: Phase 3
• First received: February 23, 2006
• Last updated: August 28, 2014
• Start date: October 2004
• Est. completion date: July 2006

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 634
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Tacrolimus
immunosuppression

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Czech Republic,  France,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  Romania,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function as assessed by calculated creatinine clearance at month 6.		6 months	No
Secondary	Acute rejection: Incidence of and time to first acute rejection		6 months	No

External Links

•   Link to FDA Website
•   Link to Results on JAPIC - enter 140561 in the JapicCTI-RNo. field