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Kidney Failure, ChronicPhase 1NCT02144285

A Study of LY3113593 in Healthy Participants and Participants With Chronic Kidney Disease Treated With Hemodialysis

A Phase 1 study testing LY3113593 in people with Kidney Failure, Chronic, run by Eli Lilly and Company at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to look at the tolerability and safety of LY3113593. Study doctors will see how safe it is and whether it produces side effects following a single injection into a vein or under the skin in healthy participants (Part A) and participants with chronic kidney disease treated with hemodialysis… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Kidney Failure, Chronic
What is being tested?
LY3113593
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
3 sitesUnited States
Study dates
Jun 2014to Aug 2015
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy Participants:
  • Healthy males or females
  • Participants have a body mass index (BMI) of 18.5 to 29.9 kilogram per meter square (kg/m^2), inclusive at screening
  • Participants Treated with Hemodialysis:
  • Participants are males or females who have end-stage renal disease (ESRD) and have been receiving adequate maintenance hemodialysis (3 times weekly) for at least 12 weeks prior to screening
  • Participants have a hemoglobin value greater than or equal to (≥)9.0 grams per deciliter (g/dL) and less than or equal to (≤)12.5 g/dL at screening
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  • Participants have a body mass index (BMI) of 18.5 to 45.0 kg/m^2, inclusive, at screening
  • Both Populations:
  • Male participants agree to use a reliable method of birth control and avoid donating sperm during the study and for 3 months following the dose of the investigational product
  • Female participants must not be of child-bearing potential

Who cannot join

  • Healthy Participants:
  • Participants that have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
  • Participants that have used or intend to use over-the-counter or prescription medication, including herbal medications within 14 days prior to dosing
  • Participants Treated with Hemodialysis:
  • Participants that have a history of myocardial infarction, acute coronary syndrome, stroke or transient ischemic attacks within the prior 6 months
  • Participants that have heart failure that results in dyspnea at rest or during minimal exercise
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  • Participants that have poorly controlled hypertension
  • Participants that have a history of significant thrombotic disease, pulmonary hypertension, significant hematological disease or current liver disease, known hepatic or biliary abnormalities
  • Participants that had a blood transfusion within the prior 12 weeks or an anticipated need for blood transfusion during the study
  • Participants that have evidence of active peptic, duodenal, or esophageal ulcer disease or gastrointestinal bleeding within the prior 12 weeks
  • Both Populations:
  • Participants that have known allergies to related compounds or any components of the study drug or its formulation, clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions or history of significant atopy
  • Participants that have participated, within the last 30 days (or 5 half-lives if long half life) in a clinical trial involving an investigational product
  • Participants that have known or ongoing psychiatric disorders

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Parexel Early Phase Unit at Glendale

    Glendale, California, 91206

  • Davita Clinical Research

    Minneapolis, Minnesota, 55404

  • Orlando Clinical Research Center

    Orlando, Florida, 32809

Other trials in United States

About this study

Official title: A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3113593 in Healthy Subjects and Patients With Chronic Kidney Disease Treated With Hemodialysis

The purpose of this study is to look at the tolerability and safety of LY3113593. Study doctors will see how safe it is and whether it produces side effects following a single injection into a vein or under the skin in healthy participants (Part A) and participants with chronic kidney disease treated with hemodialysis (Part B). The study will also measure how much of the study drug gets into the blood stream, how long it takes the body to get rid of the study drug and what effects the study drug has on the body.

This is the first time that this study drug is being given to participants. This study is for research purposes only and is not intended to treat any medical condition. For each participant, the study will last about 85 days, not including screening. Screening is required within 28 days prior to the start of the study.

Being tested
LY3113593, Placebo
Keywords
Renal dialysis
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3113593Drug

    Administered IV

  • LY3113593Drug

    Administered SC

  • PlaceboDrug

    Administered IV

  • PlaceboDrug

    Administered SC

Study groups in NCT02144285
Study groupRoleWhat they receive
LY3113593 IV (Part A)ExperimentalSingle dose of LY3113593 administered intravenous (IV) at a minimum of six dose levels
Receives: Drug: LY3113593
Placebo IV (Part A)Placebo comparatorSingle dose of placebo matching LY3113593 administered IV
Receives: Drug: Placebo
LY3113593 SC (Part A)ExperimentalSingle dose of LY3113593 administered subcutaneous (SC)
Receives: Drug: LY3113593
Placebo SC (Part A)Placebo comparatorSingle dose of placebo matching LY3113593 administered SC
Receives: Drug: Placebo
LY3113593 IV (Part B)ExperimentalSingle dose of LY3113593 administered IV
Receives: Drug: LY3113593
Placebo IV (Part B)Placebo comparatorSingle dose of placebo matching LY3113593 administered IV
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With One or More Serious Adverse Event (s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    The number of participants with 1 or more SAEs assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.

    Measured: Baseline through end of study (Day 85)

Secondary outcomes (6)

  1. Pharmacokinetics: Maximum Concentration (Cmax) of LY3113593

    Measured: Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85

  2. Pharmacokinetics: Area Under the Concentration Curve to Infinity (AUC (0-∞)) of LY3113593

    Measured: Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85

  3. Pharmacokinetics: Absolute Bioavailability of LY3113593 SC Versus IV Based on AUC Ratios

    Measured: Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85

  4. Pharmacodynamics: Maximum Change From Baseline in Iron Parameter Profile of LY3113593

    Measured: Baseline, Day 85

  5. Pharmacodynamics: Maximum Absolute Change From Baseline in TSat Parameter Profile of LY3113593

    Measured: Baseline, Day 85

  6. Pharmacodynamics: Maximum Change From Baseline in Hemoglobin (Hb) Parameter Profile of LY3113593

    Measured: Baseline, Day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02144285
Sponsor's protocol ID
15200
Other IDs
I7C-MC-FEAA
Status last verified
Aug 2018
First submitted
19 May 2014
Last updated
22 Jan 2019
Data monitoring committee
No

Publications

  • 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.

    PubMed 30677788

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3113593 in people with Kidney Failure, Chronic, run by Eli Lilly and Company at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With One or More Serious Adverse Event (s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through end of study (Day 85)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02144285, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019.

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