A Study in Participants With End-Stage Renal Disease

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to explore the effect of LY2127399 on those antibodies that are a barrier to kidney transplant. Transplantation is currently the definitive treatment for End-Stage Renal Disease (ESRD), providing prolonged survival and improved quality of life.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Have ESRD and are awaiting kidney transplant

• Have a stable PRA score >50%

Exclusion Criteria:

• Have had a tonsillectomy

• Have a semi-permanent/tunneled catheter

• Have had intravenous immunoglobulin (IVIg) in the past 6 months

• Have had plasmapheresis in the past 6 months

• Uncontrolled hypertension

• Presence of clinically significant cardiac disease in the past 6 months

• Malignancy in the past 5 years, with the exception of cervical, basal cell and squamous epithelial cell cancers

• Have active or recent infection including herpes zoster or herpes simplex in the last 30 days

• Have evidence or suspicion of active Tuberculosis (TB)

• Have had major surgery in the past 2 months

• Have had a serious infection with recovery in the past 3 months

• Have Hepatitis B or C or have Human Immunodeficiency Virus (HIV)