NCT00189735

Brief Summary

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

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
364

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2003

Geographic Reach
12 countries

37 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

April 17, 2008

Status Verified

April 1, 2008

Enrollment Period

2.1 years

First QC Date

September 12, 2005

Last Update Submit

April 15, 2008

Conditions

Kidney TransplantationRenal TransplantationTransplantation, RenalTransplantation, KidneyGrafting, Kidney

Keywords

Treatment EfficacyTreatment EffectivenessAnti-rejection therapyImmunosuppressionAntirejectionMalononitrilamide

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (19)

  • 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

  • +14 more secondary outcomes

Interventions

FK778DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

Unknown Facility

Innsbruck, 6020, Austria

Location

Unknown Facility

Brussels, 1070, Belgium

Location

Unknown Facility

Brussels, 1200, Belgium

Location

Unknown Facility

Leuven, 3000, Belgium

Location

Unknown Facility

Prague, 14021, Czechia

Location

Unknown Facility

Brest, 29 200, France

Location

Unknown Facility

Créteil, 94010, France

Location

Unknown Facility

Grenoble, France

Location

Unknown Facility

Le Kremlin-Bicêtre, 94275, France

Location

Unknown Facility

Montpellier, 34295, France

Location

Unknown Facility

Rennes, 35003, France

Location

Unknown Facility

Saint-Etienne, 42055, France

Location

Unknown Facility

Toulouse, 31 403, France

Location

Unknown Facility

Berlin, 10117, Germany

Location

Unknown Facility

Berlin, 13353, Germany

Location

Unknown Facility

Essen, 45122, Germany

Location

Unknown Facility

Frankfurt, 60590, Germany

Location

Unknown Facility

Halle, 06112, Germany

Location

Unknown Facility

München, 81675, Germany

Location

Unknown Facility

Regensburg, 93053, Germany

Location

Unknown Facility

Padua, 35128, Italy

Location

Unknown Facility

Roma, 00168, Italy

Location

Unknown Facility

Torino, 10126, Italy

Location

Unknown Facility

Maastricht, 6202, Netherlands

Location

Unknown Facility

Bydgoszcz, 85-094, Poland

Location

Unknown Facility

Szczecin, 70-111, Poland

Location

Unknown Facility

Barcelona, 08025, Spain

Location

Unknown Facility

Barcelona, 08036, Spain

Location

Unknown Facility

Barcelona, 08907, Spain

Location

Unknown Facility

Córdoba, 14004, Spain

Location

Unknown Facility

Madrid, 28034, Spain

Location

Unknown Facility

Madrid, 28041, Spain

Location

Unknown Facility

Santander, 39008, Spain

Location

Unknown Facility

Valencia, 46009, Spain

Location

Unknown Facility

Uppsala, 75185, Sweden

Location

Unknown Facility

Zurich, 8091, Switzerland

Location

Unknown Facility

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Interventions

2-cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)-2-hepten-6-ynamide

Study Officials

  • H. H. Neumayer

    Universitätsklinik Charité

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

September 1, 2003

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

April 17, 2008

Record last verified: 2008-04

Locations

CZ(1)FR(8)CH(1)DE(7)GB(1)BE(3)PL(2)IT(3)ES(8)AU(1)NL(1)SE(1)