Kidney Failure, ChronicPhase 1NCT01929109

A Study of LY2409021 in Participants With Different Levels of Kidney Function

A Phase 1 study testing LY2409021 in people with Kidney Failure, Chronic and Renal Insufficiency, Chronic, run by Eli Lilly and Company at 2 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Kidney Failure, Chronic, Renal Insufficiency, Chronic
What is being tested?: LY2409021
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 2 sitesin 2 countries
Study dates: Aug 2013to Aug 2014
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 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male participants must agree to use a reliable method of birth control in addition to having their partner use another method for the duration of the study and for 3 months after the last dose of LY2409021
Female participants must not be of child-bearing potential
Participants have a body mass index (BMI) of 18 to 40 kilogram per meter square (kg/m^2), inclusive, at screening
Additional Inclusion Criteria for Control (Healthy) Participants
Control participants must have normal renal function, assessed by mean estimated creatinine clearance (CLcr) greater than or equal to (≥)90 milliliter per minute (mL/min) at screening and day before dosing
Additional Inclusion Criteria for Participants with Mild-to-Severe Renal Impairment or End Stage Renal Disease (ESRD)

Show all 9Show fewer

Males or females with stable mild-to-severe renal impairment, assessed by estimated CLcr, or with ESRD requiring hemodialysis (or hemodiafiltration) for at least 3 months
Additional Inclusion Criteria for Participants with Type 2 Diabetes Mellitus (T2DM)
Participants with T2DM that are being treated with diet or exercise alone or receive treatment with insulin

Who cannot join

Participants that require peritoneal dialysis
Participants that have a current, functioning, organ transplant
Participants who show evidence of significant active uncontrolled endocrine or autoimmune abnormalities (for example, thyroid disease, pernicious anemia) as judged by the screening physician
Participants who had a febrile illness within 3 days prior to screening
Participants with an abnormality in the 12-lead Electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study. [Participants with a QT interval corrected using Fridericia's (QTcF) formula >450 millisecond (msec) or a PR interval >0.22 sec on the screening ECG, or who have risk factors for Torsades de Pointes]
Participants who show evidence of significant active neuropsychiatric disease

Show all 16Show fewer

Participants that are currently using or intend to use potent inhibitors of cytochrome P450 (CYP)3A, which include but are not limited to atazanavir, indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, and telithromycin
Participants who are currently using drugs with a narrow therapeutic index (for example, digoxin,lithium, phenytoin, theophylline, and warfarin)
Participants that are currently using drugs that are known to prolong the QT interval
Additional Exclusion Criteria for Participants with Mild, Moderate or Severe Renal Impairment or ESRD:
Participants that have used any drug indicated for medical care of the participant's renal impairment, which is not established in dose and administered for at least 7 days before LY2409021 administration
Participants with poorly controlled hypertension (systolic blood pressure (BP) less than (>)160, diastolic BP >95 mm Hg) and/or evidence of labile blood pressure including symptomatic postural hypotension
Participants with hemoglobin <9 grams per deciliter (g/dL) or significant active hematologic disease from causes other than underlying renal disease
Additional Exclusion Criteria for Participants with T2DM:
Participants who use an oral or injectable antihyperglycemic agent, except for insulin, within 1 month prior to dosing (Day 1)
Participants who have experienced a ketoacidotic episode (pH <7.3) requiring hospitalization in the last 6 months

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Germany1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Munich, 81241

Other trials in Germany

United Kingdom1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Liverpool, L7 8XP

Other trials in United Kingdom

About this study

Official title: Pharmacokinetics of LY2409021 Following Administration to Subjects With Varying Degrees of Renal Function

The purpose of this study was to measure how much of the study drug, LY2409021, gets into the blood stream and how long it takes the body to get rid of it when given to participants with different levels of kidney function. There were five study groups. Each participant only enrolled in one group. Participants in groups 1 through 4 were healthy or have mild, moderate, or severe kidney disease. They completed one study period lasting about 29 days. Study group 5 enrolled participants with kidney disease who were on dialysis. They have completed two study periods which together last about 59 days. Screening was required within 21 days prior to the start of the study for all participants.

Conditions: Kidney Failure, Chronic, Renal Insufficiency, Chronic
Being tested: LY2409021
Medical subject headings: Kidney Failure, Chronic, Renal Insufficiency, Chronic

What participants receive

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

LY2409021Drug
Administered orally

Study groups in NCT01929109
Study group	Role	What they receive
LY2409021 Control	Experimental	Healthy participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. Receives: Drug: LY2409021
LY2409021 Mild Renal Impairment	Experimental	Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. Receives: Drug: LY2409021
LY2409021 Moderate Renal Impairment	Experimental	Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. Receives: Drug: LY2409021
LY2409021 Severe Renal Impairment	Experimental	Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. Receives: Drug: LY2409021
LY2409021 End Stage Renal Disease	Experimental	Participants received a single 80 mg dose of LY2409021 orally on Day 1 of Period 1 of the study and a single 80 mg dose of LY2409021 orally on Day 1 of Period 2 of the study. Receives: Drug: LY2409021

What is being measured

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

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2409021
Measured: Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Curve From Time Zero to Infinity (AUC 0-∞) of LY2409021
Measured: Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose

Secondary outcomes (2)

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2409021 in Participants With End Stage Renal Disease (ESRD) Before and After Dialysis
Measured: Period 1 (Dialysis) and Period 2 (Non Dialysis) Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) (0-∞) of LY2409021 In Participants With ESRD Before and After Dialysis
Measured: Period 1 (Dialysis) and Period 2 (Non Dialysis)- Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose

Timeline

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

Aug 2013Aug 2014

First posted27 Aug 2013 (estimated)
Study startAug 2013
Primary completionAug 2014
Study completionAug 2014

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.
Other trials for Kidney Failure, ChronicStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01929109
Sponsor's protocol ID: 14578
Other IDs: I1R-MC-GLBT
Status last verified: Mar 2018
First submitted: 22 Aug 2013
Last updated: 29 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

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
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases

All Kidney Failure, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics of LY2409021 Following Administration to Subjects With Varying Degrees of Renal Function
ClinicalTrials.gov ID: NCT01929109
Acronym / sponsor ID: 14578
Conditions: Kidney Failure, Chronic, Renal Insufficiency, Chronic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Aug 2013
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 27 Aug 2013 (estimated)
Results: Posted 29 Oct 2018

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
LY2409021 Control	Experimental	Drug: LY2409021Healthy participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
LY2409021 Mild Renal Impairment	Experimental	Drug: LY2409021Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
LY2409021 Moderate Renal Impairment	Experimental	Drug: LY2409021Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
LY2409021 Severe Renal Impairment	Experimental	Drug: LY2409021Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
LY2409021 End Stage Renal Disease	Experimental	Drug: LY2409021Participants received a single 80 mg dose of LY2409021 orally on Day 1 of Period 1 of the study and a single 80 mg dose of LY2409021 orally on Day 1 of Period 2 of the study.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male participants must agree to use a reliable method of birth control in addition to having their partner use another method for the duration of the study and for 3 months after the last dose of LY2409021
Female participants must not be of child-bearing potential
Participants have a body mass index (BMI) of 18 to 40 kilogram per meter square (kg/m^2), inclusive, at screening
Additional Inclusion Criteria for Control (Healthy) Participants
Control participants must have normal renal function, assessed by mean estimated creatinine clearance (CLcr) greater than or equal to (≥)90 milliliter per minute (mL/min) at screening and day before dosing

Key exclusion criteria (16 listed)

Participants that require peritoneal dialysis
Participants that have a current, functioning, organ transplant
Participants who show evidence of significant active uncontrolled endocrine or autoimmune abnormalities (for example, thyroid disease, pernicious anemia) as judged by the screening physician
Participants who had a febrile illness within 3 days prior to screening
Participants with an abnormality in the 12-lead Electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study. [Participants with a QT interval corrected using Fridericia's (QTcF) formula >450 millisecond (msec) or a PR interval >0.22 sec on the screening ECG, or who have risk factors for Torsades de Pointes]

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
LY2409021Administered orally	Drug	LY2409021 Control, LY2409021 End Stage Renal Disease, LY2409021 Mild Renal Impairment, LY2409021 Moderate Renal Impairment, LY2409021 Severe Renal Impairment

Primary outcome

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2409021
Time frame: Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Curve From Time Zero to Infinity (AUC 0-∞) of LY2409021
Time frame: Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose

2 secondary outcomes

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2409021 in Participants With End Stage Renal Disease (ESRD) Before and After Dialysis
Time frame: Period 1 (Dialysis) and Period 2 (Non Dialysis) Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) (0-∞) of LY2409021 In Participants With ESRD Before and After Dialysis
Time frame: Period 1 (Dialysis) and Period 2 (Non Dialysis)- Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose

Results and safety

Results posted to the registry on 29 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY2409021 Control	14	14
LY2409021 Mild Renal Impairment	8	8
LY2409021 Moderate Renal Impairment	9	8
LY2409021 Severe Renal Impairment	8	8
LY2409021 End Stage Renal Disease	8	8

Primary outcome: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2409021

Time frame: Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: Nanogram per milliliter (ng/mL)

Measure	LY2409021 Control n = 14	LY2409021 Mild Renal Impairment n = 8	LY2409021 Moderate Renal Impairment n = 8	LY2409021 Severe Renal Impairment n = 8
Value	2460 (32)	2320 (30)	2190 (48)	2080 (25)

Population analysed: All participants in Groups 1-4 who received at least 1 dose of study drug and had evaluable PK data, excluding one participant (discontinued for a protocol violation). No efficacy or safety data for this participant are included in results.

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration Curve From Time Zero to Infinity (AUC 0-∞) of LY2409021

Time frame: Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: Nanogram x hour per milliliter(ng•h/mL)

Measure	LY2409021 Control n = 14	LY2409021 Mild Renal Impairment n = 8	LY2409021 Moderate Renal Impairment n = 8	LY2409021 Severe Renal Impairment n = 8
Value	181000 (40)	179000 (40)	184000 (56)	188000 (24)

2 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
LY2409021 Control	0 of 14 (0%)	8 of 14 (57.1%)	Not reported
LY2409021 Mild Renal Impairment	0 of 8 (0%)	4 of 8 (50%)	Not reported
LY2409021 Moderate Renal Impairment	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
LY2409021 Severe Renal Impairment	0 of 8 (0%)	6 of 8 (75%)	Not reported
LY2409021 End Stage Renal Disease	0 of 8 (0%)	5 of 8 (62.5%)	Not reported

Limitations and caveats (from the sponsor): One participant who received drug was identified as deviating from the protocol due to having Type 1 Diabetes Mellitus (T1DM) and was discontinued and data are not included in Baseline Characteristics, Outcome Measures or AEs.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Kidney Failure, Chronic

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
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases

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

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2409021 in people with Kidney Failure, Chronic and Renal Insufficiency, Chronic, run by Eli Lilly and Company at 2 sites in 2 countries.

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 9 inclusion and 16 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 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany, United Kingdom. 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. 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 29 Oct 2018). 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?

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2409021 (time frame: Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose). The study lists 2 primary outcomes in all. 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 NCT01929109.

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 29 Oct 2018.