A Study to Evaluate FK778 in Kidney Transplant Patients

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00189735

Collaborator

Astellas Pharma Europe B.V. (Industry)

364

Enrollment

Locations

Duration (Months)

9.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation Renal Transplantation Transplantation, Renal Transplantation, Kidney Grafting, Kidney	Drug: FK778	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

364 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2003

Actual Primary Completion Date :

Oct 1, 2005

Actual Study Completion Date :

Oct 1, 2005

Outcome Measures

Primary Outcome Measures

Incidence of biopsy-proven acute rejection over the first 24 weeks. []

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	Country	Postal Code
1	Innsbruck	Austria	6020
2	Brussels	Belgium	1070
3	Brussels	Belgium	1200
4	Leuven	Belgium	3000
5	Praha 4	Czech Republic	14021
6	Brest	France	29 200
7	Creteil Cedex	France	94010
8	Grenoble Cedex 9	France
9	Le Kremlin Bicetre Cedex	France	94275
10	Montpellier Cedex 05	France	34295
11	Rennes Cedex	France	35003
12	Saint-Etienne Cedex 02	France	42055
13	Toulouse	France	31 403
14	Berlin	Germany	10117
15	Berlin	Germany	13353
16	Essen	Germany	45122
17	Frankfurt	Germany	60590
18	Halle/Saale	Germany	06112
19	Munchen	Germany	81675
20	Regensburg	Germany	93053
21	Padova	Italy	35128
22	Roma	Italy	00168
23	Torino	Italy	10126
24	Maastricht	Netherlands	6202
25	Bydgoszcz	Poland	85-094
26	Szczecin	Poland	70-111
27	Barcelona	Spain	08025
28	Barcelona	Spain	08036
29	Barcelona	Spain	08907
30	Cordoba	Spain	14004
31	Madrid	Spain	28034
32	Madrid	Spain	28041
33	Santander	Spain	39008
34	Valencia	Spain	46009
35	Uppsala	Sweden	75185
36	Zurich	Switzerland	8091
37	Manchester	United Kingdom	M13 9WL