Chronic Kidney DiseasePhase 1NCT02604160

A Study of LY3113593 in Participants With Chronic Kidney Disease

A Phase 1 study testing LY3113593 in people with Chronic Kidney Disease, run by Eli Lilly and Company at 5 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

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Disease
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: 7 participants
Where: 5 sitesUnited States
Study dates: 17 Nov 2015to 22 Jun 2016
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
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Indiana University School of Medicine
Indianapolis, Indiana, 46202
DaVita Clinical Research
Minneapolis, Minnesota, 55404
Orlando Clinical Research Center
Orlando, Florida, 32806
Clinical Advancement Center, PLLC
San Antonio, Texas, 78215
Northwest Louisiana Nephrology
Shreveport, Louisiana, 71101

Other trials in United States

About this study

Official title: A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3113593 in Patients Receiving Hemodialysis

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.

Conditions: Chronic Kidney Disease
Being tested: LY3113593, Placebo
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

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

LY3113593Drug
Administered by slow intravenous (IV) infusion.
PlaceboDrug
Administered by slow intravenous (IV) infusion.

Study groups in NCT02604160
Study group	Role	What they receive
LY3113593	Experimental	Escalating doses of LY3113593 administered by intravenous (IV) infusion once every 4 weeks (Q4W) on (Day 1 and 29) in part A. Receives: Drug: LY3113593
Placebo	Placebo comparator	0.9% saline, administered by intravenous (IV) infusion once Q4W (Day 1 and 29) in part A. Receives: Drug: Placebo

What is being measured

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

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.
Measured: Baseline through Day 29

Secondary outcomes (4)

Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3113593
Measured: 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)
Measured: Predose; 0.5, 4 hours post-dose
Pharmacodynamics (PD): Change From Baseline to Week 8 in Hemoglobin (Hb)
Measured: 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.
Measured: Day 1: Predose; Day 15, 29, 57, 85 and 113

Timeline

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

17 Nov 201522 Jun 2016

First posted13 Nov 2015 (estimated)
Study start17 Nov 2015
Primary completion22 Jun 2016
Study completion22 Jun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02604160
Sponsor's protocol ID: 16045
Other IDs: I7C-MC-FEAC
Status last verified: Aug 2018
First submitted: 11 Nov 2015
Last updated: 21 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3113593 in Patients Receiving Hemodialysis
ClinicalTrials.gov ID: NCT02604160
Acronym / sponsor ID: 16045
Conditions: Chronic Kidney Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 17 Nov 2015
Primary completion: 22 Jun 2016 (actual)
Study completion: 22 Jun 2016 (actual)
First posted: 13 Nov 2015 (estimated)
Results: Posted 21 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
LY3113593	Experimental	Drug: LY3113593Escalating doses of LY3113593 administered by intravenous (IV) infusion once every 4 weeks (Q4W) on (Day 1 and 29) in part A.
Placebo	Placebo comparator	Drug: Placebo0.9% saline, administered by intravenous (IV) infusion once Q4W (Day 1 and 29) in part A.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY3113593Administered by slow intravenous (IV) infusion.	Drug	LY3113593
PlaceboAdministered by slow intravenous (IV) infusion.	Drug	Placebo

Primary outcome

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 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.

4 secondary outcomes

Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3113593
Time frame: Predose; 0.5, 4 hours post-dose
PK: Area Under the Concentration Versus Time (AUCτ)
Time frame: Predose; 0.5, 4 hours post-dose
Pharmacodynamics (PD): Change From Baseline to Week 8 in Hemoglobin (Hb)
Time frame: Predose; 0.5, 4 hours post-dose
Number of Participants With Anti-LY3113593 Antibodies Detection
Time frame: Day 1: Predose; Day 15, 29, 57, 85 and 113

Results and safety

Results posted to the registry on 21 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	2	2
LY3113593	5	3

Primary outcome: 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 Day 29. Count of participants. Unit: Participants

Measure	Placebo n = 2	LY3113593 n = 5
Value	0	1

Population analysed: All participants who received at least one dose of study drug or placebo, and have at least one post dose safety assessment.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 2 (0%)	2 of 2 (100%)	Not reported
LY3113593	1 of 5 (20%)	5 of 5 (100%)	Not reported

Limitations and caveats (from the sponsor): In Part A of the study, a dose stopping criterion was met leading to early conclusion of the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30677788Sheetz 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.

Related trials for Chronic Kidney Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3113593 in people with Chronic Kidney Disease, run by Eli Lilly and Company at 5 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 3 inclusion and 3 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 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 21 Mar 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 Day 29). 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 NCT02604160, 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 21 Mar 2019.