A Study to Evaluate FK778 in Kidney Transplant Patients

Kidney Transplantation Clinical Trial

Official title:

A Multicentre, Randomised, Double-Blind, Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Different Concentrations of FK778 With Tacrolimus (FK506) and Steroids Versus a Standard Regimen of Tacrolimus, MMF and Steroids in Renal Transplant Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189735
• Other study ID #: FG-778-02-60
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: April 15, 2008
• Start date: September 2003
• Est. completion date: October 2005

Study information

• Verified date: April 2008
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Belgium: Federal Agency for Medicines and Health Products, FAMHPPoland: Ministry of HealthCzech Republic: State Institute for Drug ControlUnited Kingdom: National Health ServiceSpain: Spanish Agency of MedicinesSweden: Medical Products AgencyItaly: Ministry of HealthAustria: Federal Ministry for Health and WomenSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

A dose finding study to evaluate the safety and effectiveness of FK778 in kidney transplant patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient has end stage kidney disease or needs retransplantation (loss of graft for non-immunological reasons).

• Patient has been fully informed.

Exclusion Criteria:

• Patient has an immunological high risk and/or having a previous graft survival shorter than 1 year due to immunological reasons.

• Patient has significant liver disease.

• Cold ischemia time of the donor kidney >28 hours.

• Patient having uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.

• Patient has previously received or is receiving an organ transplant other than kidney.

Study Design

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

Related Conditions & MeSH terms

• Grafting, Kidney
• Kidney Transplantation
• Renal Transplantation
• Transplantation, Kidney
• Transplantation, Renal

Intervention

Drug:
• FK778

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma Europe B.V.

Countries where clinical trial is conducted

Austria,  Belgium,  Czech Republic,  France,  Germany,  Italy,  Netherlands,  Poland,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of biopsy-proven acute rejection over the first 24 weeks.
Secondary	Efficacy:Incidence of and time to first biopsy-proven acute rejection over the first 24 weeks and after 1 year
Secondary	Incidence of and time to first corticosteroid-resistant acute rejections over the first 24 weeks and after 1 year
Secondary	Incidence of and time to first acute rejection by signs and symptoms over the first 24 weeks and after 1 year
Secondary	Severity of biopsy-proven acute rejections (Banff criteria) over the first 24 weeks and after 1 year
Secondary	Frequency of treatment failure (as defined below) over the first 24 weeks and after 1 year
Secondary	Renal function as measured by serum creatinine concentrations and calculated creatinine clearance (Cockcroft formula) over the first 24 weeks and after 1 year
Secondary	Chronic allograft dysfunction assessed by chronic allograft damage index (CADI) after 24 weeks of transplantation.
Secondary	Safety first 24 weeks: Patient survival
Secondary	Graft survival
Secondary	Incidence of adverse events
Secondary	Routine safety laboratory parameters
Secondary	Haemoglobin values at weeks two to six
Secondary	Leukocytes at weeks two to six
Secondary	Thrombocytes at weeks two to six
Secondary	Bilirubin at weeks two to six
Secondary	Incidence of CMV viraemia
Secondary	Incidence of Diarrhoea, Gastroenteritis and Gastritis
Secondary	Safety after 1 year:Incidence of adverse events
Secondary	Patient and graft survival