A Study to Evaluate FK778 in Kidney Transplant Patients - Full Text View

Sponsors and Collaborators:	Astellas Pharma Inc Astellas Pharma Europe BV
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00189735

Purpose

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

Condition	Intervention	Phase
Kidney Transplantation Renal Transplantation Transplantation, Renal Transplantation, Kidney Grafting, Kidney	Drug: FK778	Phase II

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: FK 778

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Secondary Outcome Measures:

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

Enrollment:	364
Study Start Date:	September 2003
Study Completion Date:	October 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Eligibility

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189735

Sponsors and Collaborators

Astellas Pharma Inc

Astellas Pharma Europe BV

Investigators

Principal Investigator:

H. H. Neumayer

Universitätsklinik Charité

More Information

No publications provided

Study ID Numbers:	FG-778-02-60
Study First Received:	September 12, 2005
Last Updated:	April 15, 2008
ClinicalTrials.gov Identifier:	NCT00189735 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; France: Afssaps - French Health Products Safety Agency; Belgium: Directorate general for the protection of Public health: Medicines; Poland: Ministry of Health; Czech Republic: State Institute for Drug Control; United Kingdom: National Health Service; France: Afssaps - French Health Products Safety Agency; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Italy: Ministry of Health; Austria: Federal Ministry for Health and Women; Switzerland: Swissmedic

Keywords provided by Astellas Pharma Inc:

Treatment Efficacy
Treatment Effectiveness
Anti-rejection therapy

Immunosuppression
Antirejection
Malononitrilamide

Study placed in the following topic categories:

Tacrolimus

ClinicalTrials.gov processed this record on May 07, 2009