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| ID | Type | Description | Link |
|---|---|---|---|
| I7C-MC-FEAC | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3113593 | Experimental | Escalating doses of LY3113593 administered by intravenous (IV) infusion once every 4 weeks (Q4W) on (Day 1 and 29) in part A. |
|
| Placebo | Placebo Comparator | 0.9% saline, administered by intravenous (IV) infusion once Q4W (Day 1 and 29) in part A. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3113593 | Drug | Administered by slow intravenous (IV) infusion. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline through Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3113593 | Predose; 0.5, 4 hours post-dose | |
| PK: Area Under the Concentration Versus Time (AUCτ) | Area under the concentration versus time (AUCτ) is the AUC over the dosing interval (Q4W) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Orlando | Florida | 32806 | United States | ||
| Indiana University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30677788 | Derived | Sheetz M, Barrington P, Callies S, Berg PH, McColm J, Marbury T, Decker B, Dyas GL, Truhlar SME, Benschop R, Leung D, Berg J, Witcher DR. Targeting the hepcidin-ferroportin pathway in anaemia of chronic kidney disease. Br J Clin Pharmacol. 2019 May;85(5):935-948. doi: 10.1111/bcp.13877. Epub 2019 Mar 4. |
| Label | URL |
|---|---|
| Click here for more information about this study: A Study of LY3113593 in Participants With Chronic Kidney Disease | View source |
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In Part A of the study, a dose stopping criterion was met leading to early conclusion of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 0.9% saline, administered by intravenous (IV) infusion once every four weeks (Q4W) (Day 1 and 29) in part A. |
| FG001 | LY3113593 | 50 milligram (mg) of LY3113593 administered by IV infusion Q4W (Day 1 and 29) in part A. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 0.9% saline, administered by intravenous (IV) infusion once every four weeks (Q4W) (Day 1 and 29) in part A. |
| BG001 | LY3113593 | 50 milligram (mg) of LY3113593 administered by IV infusion Q4W (Day 1 and 29) in part A. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who received at least one dose of study drug or placebo, and have at least one post dose safety assessment. | Posted | Count of Participants | Participants | No | Baseline through Day 29 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 0.9% saline, administered by slow IV infusion Q4W (Day 1 and 29) in part A. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
In Part A of the study, a dose stopping criterion was met leading to early conclusion of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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single-blind participant only
| Placebo |
| Drug |
Administered by slow intravenous (IV) infusion. |
|
| Predose; 0.5, 4 hours post-dose |
| 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 | 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. | Day 1: Predose; Day 15, 29, 57, 85 and 113 |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Northwest Louisiana Nephrology | Shreveport | Louisiana | 71101 | United States |
| DaVita Clinical Research | Minneapolis | Minnesota | 55404 | United States |
| Clinical Advancement Center, PLLC | San Antonio | Texas | 78215 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
50 mg of LY3113593 administered by IV infusion Q4W (Day 1 and 29) in part A.
|
|
| Secondary | Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3113593 | All participants who received at least one dose of study drug and have evaluable PK data. PK was not assessed in placebo. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/mL) | Predose; 0.5, 4 hours post-dose |
|
|
|
| Secondary | PK: Area Under the Concentration Versus Time (AUCτ) | Area under the concentration versus time (AUCτ) is the AUC over the dosing interval (Q4W) | All participants who received at least one dose of study drug and had evaluable PK data. PK was not assessed in placebo. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram.hour/milliliter (ug*h/mL) | Predose; 0.5, 4 hours post-dose |
|
|
|
| Secondary | Pharmacodynamics (PD): Change From Baseline to Week 8 in Hemoglobin (Hb) | 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. | Posted | Predose; 0.5, 4 hours post-dose |
|
|
| 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. | All participants who received at least one dose of study drug, and have at least one post dose safety assessment. | Posted | Count of Participants | Participants | No | Day 1: Predose; Day 15, 29, 57, 85 and 113 |
|
|
|
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | LY3113593 | 50 mg of LY3113593 administered by slow IV infusion Q4W (Day 1 and 29) in part A. | 1 | 5 | 5 | 5 |
| Hyperparathyroidism secondary | Endocrine disorders | MedDRA 18.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Day 29 ± 2 days; 1:80 Titer |
|
| Day 57 ± 2 days; 1:40 Titer |
|
| Day 85 ± 2 days; 1:40 Titer |
|
| Day 113; ± 2 days; 1:40 Titer |
|