Trials Sponsors Conditions Drugs Pricing

Conditions

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

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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:

Sponsors & Collaborators

Astellas Pharma Europe B.V.
Industrycollaborator
Astellas Pharma Inc
Industrylead

Study Sites (37)

Innsbruck, 6020, Austria

Brussels, 1070, Belgium

Brussels, 1200, Belgium

Leuven, 3000, Belgium

Prague, 14021, Czechia

Brest, 29 200, France

Créteil, 94010, France

Grenoble, France

MeSH Terms

Interventions

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

Study Officials

H. H. Neumayer
Universitätsklinik Charité
PRINCIPAL INVESTIGATOR

Enrollment

364 participants (actual enrollment reported by the registry).

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 2003

Date type not reported

This date has not been verified as actual or estimated.

A Study to Evaluate FK778 in Kidney Transplant Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (19)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (37)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (19)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (37)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations