A Study in Participants With End-Stage Renal Disease
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/16/2018 |
| Start Date: | April 2011 |
| End Date: | March 2014 |
An Exploratory/Proof of Concept Investigation of the Safety and Pharmacodynamics of LY2127399 in HLA-Presensitized Patients With End-Stage Renal Disease Awaiting Transplantation
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.
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.
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.
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.
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)
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