A Study in Participants With End-Stage Renal Disease

NCT01200290 | Completed Phase 2 Results

• 2 other identifiers: 13710H9B-MC-BCDR
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Failure, Chronic

Keywords

end stage renal disease; end stage kidney disease; ESRD; Uremia; Renal Dialysis

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in PRA

  The PRA value is calculated and expressed as a percentage, which can range from 0 % to 100%. The value represents a summation of the total HLA antibody burden that the participant has and how frequently those HLA antigens appear in organ donor population. A calculated PRA of 20% means the participant has antibodies that represent an antigen frequency that exists in approximately 20% of the population.

  Baseline, Weeks 8, 16, 24, 36, 52, 64 and 76

• Change From Baseline in Arcsine Transformed PRA Scores

  The PRA value is calculated and expressed as a percentage, which can range from 0% to 100%. The value represents a summation of the total HLA antibody burden that the participant has and how frequently those HLA antigens appear in organ donor population. A calculated PRA of 20% means the participant has antibodies that represent an antigen frequency that exists in approximately 20% of the population. PRA scores were transformed using the arcsine function, which enables a skewed distribution of data typically expressed as proportions to achieve properties closer to a normal distribution. The range of possible arcsine transformed PRA scores is 0 (when PRA = 0) to approximately 1.57 (when PRA =100). Higher scores indicate the participant has antibodies against HLA antigens that appear frequently in the organ donor population.

  Baseline, Weeks 8, 16, 24, 36, 52, 64 and 76

• Number of Participants With a Change From Baseline Positive to Post-Baseline Negative in the Summation of Top 10 Highest Antibody Levels (Class I and Class II Single Antigen Reactivity Reported Separately) During Treatment and Follow-Up

  Baseline through Weeks 24, 52 and 76

Secondary Outcomes (5)

• Change From Baseline in Serum Immunoglobulin Levels

  Baseline, Weeks 8, 16, 24, 36 and 52

• Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil

  Baseline, Weeks 1 and 24

• Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood

  Baseline, Weeks1, 4, 8, 16, 24, 36, 52, 64 and 76

• Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood

  Baseline, Weeks1, 4, 8, 16, 24, 36 and 52

• Population Pharmacokinetics (PK): Constant Clearance

  Baseline through Week 24

Study Arms (1)

LY2127399

EXPERIMENTAL

Drug: LY2127399

Interventions

LY2127399 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

LY2127399

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have ESRD and are awaiting kidney transplant
• Have a stable PRA score \>50%

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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, 46202, United States

Location

Related Publications (1)

• Mujtaba MA, Komocsar WJ, Nantz E, Samaniego MD, Henson SL, Hague JA, Lobashevsky AL, Higgins NG, Czader M, Book BK, Anderson MD, Pescovitz MD, Taber TE. Effect of Treatment With Tabalumab, a B Cell-Activating Factor Inhibitor, on Highly Sensitized Patients With End-Stage Renal Disease Awaiting Transplantation. Am J Transplant. 2016 Apr;16(4):1266-75. doi: 10.1111/ajt.13557. Epub 2016 Jan 18.

  PMID: 26780484 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Uremia

Interventions

tabalumab

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: September 13, 2010
• Study Start: April 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 14, 2018
• Results First Posted: May 14, 2018

Record last verified: 2018-05

Locations

US (1)