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Trial record 5 of 1468 for:    "Kidney Failure, Chronic"

A Study in Patients With End-Stage Renal Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01200290
Recruitment Status : Completed
First Posted : September 13, 2010
Last Update Posted : October 8, 2014
Information provided by (Responsible Party):
Eli Lilly and Company

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 Disease (ESRD), providing prolonged survival and improved quality of life.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Drug: LY2127399 Phase 2

Detailed Description:
In this study, LY2127399 will be tested as a potential treatment to reduce the blood proteins in some patients with End-Stage Renal Disease (ESRD). These proteins are called alloantibodies and are made by the body to react with other proteins called HLA proteins. When a person has these antibodies, they are referred to as HLA-presensitized. Often the presence of these antibodies, measured by a test called the PRA (panel reactive antibody), 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 patients for 6 months with LY2127399 and measure PRA levels for a total of 18 months.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Exploratory/Proof of Concept Investigation of the Safety and Pharmacodynamics of LY2127399 in HLA-Presensitized Patients With End-Stage Renal Disease Awaiting Transplantation
Study Start Date : April 2011
Primary Completion Date : March 2014
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: LY2127399 Drug: LY2127399
120mg 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

Primary Outcome Measures :
  1. Change from baseline through 76 weeks in Single Antigen Reactivity [ Time Frame: Baseline through 76 weeks ]
  2. Change from baseline through 76 weeks in Panel Reactive Antibodies (PRA) [ Time Frame: Baseline through 76 weeks ]

Secondary Outcome Measures :
  1. Change from baseline through 76 weeks in serum immunoglobulin levels [ Time Frame: Baseline through 76 weeks ]
  2. Change from baseline at week 1 and week 24 in B-cell populations in the tonsil [ Time Frame: Baseline, week 1, week 24 ]
  3. Change from baseline through 76 weeks in relative percentages of B-cell populations in peripheral blood [ Time Frame: Baseline through 76 weeks ]
  4. Change from baseline through 76 weeks in absolute counts of B-cell populations in peripheral blood [ Time Frame: Baseline through 76 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200290

United States, Indiana
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
Sponsors and Collaborators
Eli Lilly and Company
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01200290     History of Changes
Other Study ID Numbers: 13710
H9B-MC-BCDR ( Other Identifier: Eli Lilly and Company )
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: October 8, 2014
Last Verified: September 2014

Keywords provided by Eli Lilly and Company:
end stage renal disease
end stage kidney disease
Renal Dialysis

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs