Clinical trial NCT00189735: A Study to Evaluate FK778 in Kidney Transplant Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Transplantation
Renal Transplantation
Transplantation, Renal
Transplantation, Kidney
Grafting, Kidney
Keywords: Treatment Efficacy
Treatment Effectiveness
Anti-rejection therapy
Immunosuppression
Antirejection
Malononitrilamide
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Europe B.V.
First posted: 2005-09-19
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Incidence of biopsy-proven acute rejection over the first 24 weeks.
Secondary outcomes:
measure: Efficacy:Incidence of and time to first biopsy-proven acute rejection over the first 24 weeks and after 1 year
measure: Incidence of and time to first corticosteroid-resistant acute rejections over the first 24 weeks and after 1 year
measure: Incidence of and time to first acute rejection by signs and symptoms over the first 24 weeks and after 1 year
measure: Severity of biopsy-proven acute rejections (Banff criteria) over the first 24 weeks and after 1 year
measure: Frequency of treatment failure (as defined below) over the first 24 weeks and after 1 year
measure: Renal function as measured by serum creatinine concentrations and calculated creatinine clearance (Cockcroft formula) over the first 24 weeks and after 1 year
measure: Chronic allograft dysfunction assessed by chronic allograft damage index (CADI) after 24 weeks of transplantation.
measure: Safety first 24 weeks: Patient survival
measure: Graft survival
measure: Incidence of adverse events
measure: Routine safety laboratory parameters
measure: Haemoglobin values at weeks two to six
measure: Leukocytes at weeks two to six
measure: Thrombocytes at weeks two to six
measure: Bilirubin at weeks two to six
measure: Incidence of CMV viraemia
measure: Incidence of Diarrhoea, Gastroenteritis and Gastritis
measure: Safety after 1 year:Incidence of adverse events
measure: Patient and graft survival
Other outcomes:
Locations:
city: Innsbruck
country: Austria
city: Brussels
country: Belgium
city: Brussels
country: Belgium
city: Leuven
country: Belgium
city: Praha 4
country: Czech Republic
city: Brest
country: France
city: Creteil Cedex
country: France
city: Grenoble Cedex 9
country: France
city: Le Kremlin Bicetre Cedex
country: France
city: Montpellier Cedex 05
country: France
city: Rennes Cedex
country: France
city: Saint-Etienne Cedex 02
country: France
city: Toulouse
country: France
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Essen
country: Germany
city: Frankfurt
country: Germany
city: Halle/Saale
country: Germany
city: Munchen
country: Germany
city: Regensburg
country: Germany
city: Padova
country: Italy
city: Roma
country: Italy
city: Torino
country: Italy
city: Maastricht
country: Netherlands
city: Bydgoszcz
country: Poland
city: Szczecin
country: Poland
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Cordoba
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Santander
country: Spain
city: Valencia
country: Spain
city: Uppsala
country: Sweden
city: Zurich
country: Switzerland
city: Manchester
country: United Kingdom
Study officials:
affiliation: Universitätsklinik Charité
name: H. H. Neumayer
role: PRINCIPAL_INVESTIGATOR
References: