Chronic Kidney Disease
Conditions
Brief summary
This study is not intended to treat anemia of chronic kidney disease but to determine the safety of the study drug, LY3113593. The study will also evaluate how much of the study drug gets into the blood stream, how long it takes the body to remove the study drug, and what effect the study drug has on the body. The study consists of up to three parts. Participants may only enroll in one part. Participants will receive up to four injections of LY3113593 or placebo into a vein. The study will last up to about 26 weeks including screening and follow-up.
Interventions
DRUGLY3113593
Administered by slow intravenous (IV) infusion.
DRUGPlacebo
Administered by slow intravenous (IV) infusion.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
single-blind participant only
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Receiving hemodialysis regularly (at least 3 times per week) for at least 4 months * Have a hemoglobin value (taken prior to dialysis, if taken on a dialysis day) greater than or equal to 9.5 grams per deciliter (g/dL) and less than or equal to 11.0 g/dL at screening * Have been receiving erythropoiesis stimulating agent (ESA) injections for at least 4 weeks and are willing to stop the injections for approximately 8 weeks
Exclusion criteria
* Have another health condition that may put the participant at risk or that the study doctor feels would make the participant unsuitable for the study * Currently taking part in another study * Have recently (within 30 days) completed a study or have previously taken part in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline through Day 29 | A summary of other non-serious adverse events (AEs) and all serious adverse events, regardless of causality, is located in the reported adverse events section. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3113593 | Predose; 0.5, 4 hours post-dose | — |
| PK: Area Under the Concentration Versus Time (AUCτ) | Predose; 0.5, 4 hours post-dose | Area under the concentration versus time (AUCτ) is the AUC over the dosing interval (Q4W) |
| Pharmacodynamics (PD): Change From Baseline to Week 8 in Hemoglobin (Hb) | Predose; 0.5, 4 hours post-dose | — |
| Number of Participants With Anti-LY3113593 Antibodies Detection | Day 1: Predose; Day 15, 29, 57, 85 and 113 | Participants with a detection of anti-LY3113593 antibodies at baseline and post-baseline time point at the following levels of 1:20, 1:40 or 1:80 titer. |
Countries
United States
Participant flow
Pre-assignment details
In Part A of the study, a dose stopping criterion was met leading to early conclusion of the study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo 0.9% saline, administered by intravenous (IV) infusion once every four weeks (Q4W) (Day 1 and 29) in part A. | 2 |
| LY3113593 50 milligram (mg) of LY3113593 administered by IV infusion Q4W (Day 1 and 29) in part A. | 5 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | LY3113593 | Total | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 3 Participants | 0 Participants |
| Region of Enrollment United States | 5 Participants | 7 Participants | 2 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 2 | 5 / 5 |
| serious Total, serious adverse events | 0 / 2 | 1 / 5 |
Outcome results
Primary
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of other non-serious adverse events (AEs) and all serious adverse events, regardless of causality, is located in the reported adverse events section.
Time frame: Baseline through Day 29
Population: All participants who received at least one dose of study drug or placebo, and have at least one post dose safety assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| LY3113593 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 1 Participants |
Secondary
Number of Participants With Anti-LY3113593 Antibodies Detection
Participants with a detection of anti-LY3113593 antibodies at baseline and post-baseline time point at the following levels of 1:20, 1:40 or 1:80 titer.
Time frame: Day 1: Predose; Day 15, 29, 57, 85 and 113
Population: All participants who received at least one dose of study drug, and have at least one post dose safety assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Anti-LY3113593 Antibodies Detection | Day 15 ± 2 days; 1:20 Titer | 1 Participants |
| Placebo | Number of Participants With Anti-LY3113593 Antibodies Detection | Day 57 ± 2 days; 1:40 Titer | 1 Participants |
| Placebo | Number of Participants With Anti-LY3113593 Antibodies Detection | Day 1 Predose; 1:80 Titer | 1 Participants |
| Placebo | Number of Participants With Anti-LY3113593 Antibodies Detection | Day 85 ± 2 days; 1:40 Titer | 1 Participants |
| Placebo | Number of Participants With Anti-LY3113593 Antibodies Detection | Day 29 ± 2 days; 1:80 Titer | 1 Participants |
| Placebo | Number of Participants With Anti-LY3113593 Antibodies Detection | Day 113; ± 2 days; 1:40 Titer | 0 Participants |
| LY3113593 | Number of Participants With Anti-LY3113593 Antibodies Detection | Day 29 ± 2 days; 1:80 Titer | 0 Participants |
| LY3113593 | Number of Participants With Anti-LY3113593 Antibodies Detection | Day 1 Predose; 1:80 Titer | 0 Participants |
| LY3113593 | Number of Participants With Anti-LY3113593 Antibodies Detection | Day 15 ± 2 days; 1:20 Titer | 0 Participants |
| LY3113593 | Number of Participants With Anti-LY3113593 Antibodies Detection | Day 113; ± 2 days; 1:40 Titer | 0 Participants |
| LY3113593 | Number of Participants With Anti-LY3113593 Antibodies Detection | Day 57 ± 2 days; 1:40 Titer | 0 Participants |
| LY3113593 | Number of Participants With Anti-LY3113593 Antibodies Detection | Day 85 ± 2 days; 1:40 Titer | 0 Participants |
Secondary
Pharmacodynamics (PD): Change From Baseline to Week 8 in Hemoglobin (Hb)
Time frame: Predose; 0.5, 4 hours post-dose
Population: Zero participants were analyzed; data not collected. Change from baseline to week 8 in Hemoglobin (Hb) was not assessed since study was concluded early at part A.
Secondary
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3113593
Time frame: Predose; 0.5, 4 hours post-dose
Population: All participants who received at least one dose of study drug and have evaluable PK data. PK was not assessed in placebo.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3113593 | Day 1 | 11934 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 30 |
| Placebo | Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3113593 | Day 29 | 13567 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 42 |
Secondary
PK: Area Under the Concentration Versus Time (AUCτ)
Area under the concentration versus time (AUCτ) is the AUC over the dosing interval (Q4W)
Time frame: Predose; 0.5, 4 hours post-dose
Population: All participants who received at least one dose of study drug and had evaluable PK data. PK was not assessed in placebo.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | PK: Area Under the Concentration Versus Time (AUCτ) | Day 1 | 2281 microgram.hour/milliliter (ug*h/mL) | Geometric Coefficient of Variation 36 |
| Placebo | PK: Area Under the Concentration Versus Time (AUCτ) | Day 29 | 2707 microgram.hour/milliliter (ug*h/mL) | Geometric Coefficient of Variation 36 |