A Study in Participants With End-Stage Renal Disease

Lilly

Status and phase

Completed

Phase 2

Conditions

Kidney Failure, Chronic

Treatments

Drug: LY2127399

Study type

Interventional

Funder types

Industry

Identifiers

NCT01200290

13710

H9B-MC-BCDR (Other Identifier)

Details and patient eligibility

About

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.

Full description

In this study, LY2127399 will be tested as a potential treatment to reduce the blood proteins in some participants with ESRD. These proteins are called alloantibodies and are made by the body to react with other proteins on cells of transplanted organs called human leukocyte antigen (HLA) proteins. When a participant has these antibodies, they are referred to as HLA-presensitized. Often the presence of these antibodies, categorized by a method called the panel reactive antibody (PRA), can make a person ineligible to receive a transplant or experience very long wait times on the kidney transplant waiting list. Therefore the need to reduce the antibodies is significant for the successful treatment of ESRD. This study will treat ESRD participants for 6 months with LY2127399 and measure PRA levels for a total of 18 months.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)