A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Kidney Transplantation

Kidney Transplantation Clinical Trial

Official title:

A Multicentre, Randomised, Double Blind, Two Arm Parallel Group Study to Evaluate and Compare the Efficacy and Safety of Modified Release Tacrolimus FK506E (MR4) Versus Tacrolimus FK506 in Combination With MMF (Cellcept®) and Steroids in Patients Undergoing Kidney Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189839
• Other study ID #: FG-506E-12-03
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: July 7, 2014
• Start date: August 2004
• Est. completion date: December 2006

Study information

• Verified date: July 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustria: Federal Ministry for Health and WomenAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Federal Agency for Medicines and Health Products, FAMHPBrazil: National Committee of Ethics in ResearchCanada: Health CanadaSwitzerland: SwissmedicCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesSpain: Spanish Agency of MedicinesFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United Kingdom: National Health ServiceGreece: National Organization of MedicinesHungary: National Institute of PharmacyIreland: Irish Medicines BoardItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthMexico: National Council of Science and TechnologyNetherlands: Medicines Evaluation Board (MEB)Norway: Norwegian Medicines AgencyPoland: Ministry of HealthSweden: Medical Products AgencySouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate and to compare the efficacy and safety of a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen in patients undergoing kidney transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.

Description:

A multicentre, 1:1 randomised, double blind, double dummy, two arm parallel group phase III study comparing a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 699
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients receiving a kidney transplant from a cadaveric donor or a living non HLA identical donor between 5 and 65 years of age with compatible ABO blood type.

• Patients with end stage kidney disease who are suitable candidates for primary renal transplantation or re-transplantation (unless the graft was lost because of immunological reasons within 12 months).

Exclusion Criteria:

• Patients receiving or having previously received an organ transplant other than a kidney.

• Patients with a high immunological risk, defined as a panel reactive antibodies (PRA) grade >50% in the previous 6 months and/or with a previous graft survival of less than 12 months due to immunological reasons.

• Cold ischaemia time of the donor kidney >30 hours.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, 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

Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Czech Republic,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Mexico,  Netherlands,  Norway,  Poland,  South Africa,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to and incidence of biopsy-proven acute rejections		12 months	No
Secondary	Overall rate of acute rejections		12 months	No

External Links

•   Link to Results on JAPIC - enter 140498 in the JapicCTI-RNo. field