Status:
COMPLETED
A Study in Participants With End-Stage Renal Disease
Lead Sponsor:
Eli Lilly and Company
Conditions:
Kidney Failure, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 D...
Detailed 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...
Eligibility Criteria
Inclusion
- Have ESRD and are awaiting kidney transplant
- Have a stable PRA score \>50%
Exclusion
- 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)
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01200290
Start Date
April 1 2011
End Date
March 1 2014
Last Update
May 14 2018
Active Locations (1)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Indianapolis, Indiana, United States, 46202