TerminatedPhase 2

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

Stopped: Lack of efficacy

Spain, United Kingdom7 participantsStarted 2016-08-27

Plain-language summary

This is a phase 2 study to evaluate the efficacy, safety, tolerability and pharmacokinetics of GSK1070806 in subjects undergoing renal transplantation. GSK1070806 is an anti-interleukin 18 (IL18) monoclonal antibody, which binds to IL-18 and inhibits signaling through the IL-18 receptor. Recipients of donor kidneys, retrieved after circulatory death of the donor, will be administered a single intravenous infusion of GSK1070806 to test whether inhibition of IL-18 can reduce the rate of Delayed Graft Function (DGF) and graft rejection. Subjects will be followed for 12 months post dose/transplant. Up to 40 adult subjects will be enrolled in this study.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Males: Male subjects with female partners of child bearing potential must utilize a condom and female partners must comply with use of highly effective contraceptive methods for 180 days post-dose of study medication.
✓. Females:

What they're measuring

Number of Participants Requiring Dialysis During the First 7 Days Post Transplant

Timeframe: Up to Day 7

Trial details

NCT IDNCT02723786

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-03-31

Results submitted2018-03-30

View on ClinicalTrials.gov More Kidney Transplantation (Status Post) trials