Phase 2
N=18
A Study in Participants With End-Stage Renal Disease
Kidney Failure, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT01200290 ↗Enrolled (actual)
18
Serious AEs
50.0%
Results posted
May 2018
Primary outcome: Primary: Change From Baseline in PRA — -0.706; -2.176; -1.688; -2.353 percentage of population — p=0.324
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LY2127399 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in PRA |
-0.706; -2.176; -1.688; -2.353; -0.529; -1.706 | 0.324 |
| PRIMARY Change From Baseline in Arcsine Transformed PRA Scores |
-0.022; -0.059; -0.060; -0.078; -0.014; -0.053 | 0.335 |
| PRIMARY 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 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Serum Immunoglobulin Levels |
-0.305; -0.261; -0.409; -0.325; -0.098; -1.625 | — |
| SECONDARY Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil |
12.732; -25.371; -1.559; -21.611; 11.850; 92.905 | — |
| SECONDARY Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood |
35.303; -10.883; -28.765; -45.027; -52.115; -63.677 | — |
| SECONDARY Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood |
37.305; -12.050; -27.875; -46.861; -55.759; -68.301 | — |
| SECONDARY Population Pharmacokinetics (PK): Constant Clearance |
5.65 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT01200290). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.