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A Study in Patients With End-Stage Renal Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01200290
First received: September 3, 2010
Last updated: November 21, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
Kidney Failure, Chronic
 Drug: LY2127399
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure
U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from baseline through 76 weeks in Single Antigen Reactivity [ Time Frame: Baseline through 76 weeks ] [ Designated as safety issue: No ]
  • Change from baseline through 76 weeks in Panel Reactive Antibodies (PRA) [ Time Frame: Baseline through 76 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline through 76 weeks in serum immunoglobulin levels [ Time Frame: Baseline through 76 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline at week 1 and week 24 in B-cell populations in the tonsil [ Time Frame: Baseline, week 1, week 24 ] [ Designated as safety issue: No ]
  • Change from baseline through 76 weeks in relative percentages of B-cell populations in peripheral blood [ Time Frame: Baseline through 76 weeks ] [ Designated as safety issue: No ]
  • Change from baseline through 76 weeks in absolute counts of B-cell populations in peripheral blood [ Time Frame: Baseline through 76 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: April 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200290

Locations
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
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01200290     History of Changes
Other Study ID Numbers: 13710, H9B-MC-BCDR
Study First Received: September 3, 2010
Last Updated: November 21, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on May 16, 2013