CompletedPhase 2

A Study in Participants With End-Stage Renal Disease

United States18 participantsStarted 2011-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in PRA

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

Change From Baseline in Arcsine Transformed PRA Scores

Timeframe: 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

Timeframe: Baseline through Weeks 24, 52 and 76

Trial details

NCT IDNCT01200290

SponsorEli Lilly and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-03

Results submitted2018-03-24

View on ClinicalTrials.gov More Kidney Failure, Chronic trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change From Baseline in PRA

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

Change From Baseline in Arcsine Transformed PRA Scores

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

Timeframe: Baseline through Weeks 24, 52 and 76