Efficacy, Safety, Tolerability and Pharmacokinetic (PK) Study of GSK1070806 for the Prevention of Delayed Graft Function (DGF) in Adult Subjects After Renal Transplantation

PHASE2TerminatedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

August 27, 2016

Primary Completion Date

March 31, 2017

Study Completion Date

March 6, 2018

Conditions
Kidney Transplantation (Status Post)
Interventions
BIOLOGICAL

GSK1070806

Injectable solution of 100 milligram/millilitre (mg/mL), administered as a single dose of 3 milligram/kilogram (mg/kg) (maximum of 10 mg/kg) diluted in 100 mL sterile IV infusion bag of 0.9% Sodium Chloride.

DRUG

1) basiliximab 2) mycophenolate mofetil (MMF) OR azathioprine 3) tacrolimus 4) corticosteroids

This immunosuppressant regimen may be revised based on the clinical judgment of the investigator including titration of tacrolimus levels.

Trial Locations (4)

08907

GSK Investigational Site, L'Hospitalet de Llobregat

CB2 0QQ

GSK Investigational Site, Cambridge

G51 4TF

GSK Investigational Site, Glasgow

NE7 7DN

GSK Investigational Site, Newcastle upon Tyne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02723786 - Efficacy, Safety, Tolerability and Pharmacokinetic (PK) Study of GSK1070806 for the Prevention of Delayed Graft Function (DGF) in Adult Subjects After Renal Transplantation | Biotech Hunter | Biotech Hunter