A Study in Participants With End-Stage Renal Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Kidney Failure, Chronic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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LY2127399

Group Type EXPERIMENTAL

LY2127399

Intervention Type DRUG

120 milligrams (mg) administered subcutaneously every 4 weeks for 20 weeks. A loading dose of 240 mg will be given as the first dose of the study medication

Interventions

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LY2127399

120 milligrams (mg) administered subcutaneously every 4 weeks for 20 weeks. A loading dose of 240 mg will be given as the first dose of the study medication

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No