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Kidney Failure, ChronicPhase 1NCT03546205

A Study to Evaluate JNJ-64565111 Pharmacokinetics and Safety in Adult Participants With Varying Degrees of Renal Function

A Phase 1 study testing JNJ-64565111 in people with Kidney Failure, Chronic, run by Janssen Research & Development, LLC at 2 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 study is to evaluate the pharmacokinetics of a single, subcutaneous dose of JNJ-64565111 in adult participants with varying degrees of renal function including participants with end stage renal disease, requiring hemodialysis, compared with participants with normal renal function. Read more about this study

Who is it for?
Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Kidney Failure, Chronic
What is being tested?
JNJ-64565111
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesUnited States
Study dates
6 Jun 2018to 17 Dec 2018
Phase
Phase 1
Are there results?
None posted in the registry

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 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • If a woman, must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, or if sexually active, be practicing an effective method of birth control before entry and throughout the study
  • A woman must have a negative highly sensitive serum (beta human chorionic gonadotropin [hCG]) at screening. On Day -1, female non-end-stage renal disease (ESRD) participants should have a negative urine pregnancy test and female ESRD participants requiring hemodialysis (HD) should have a negative serum pregnancy test
  • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction (from screening through Day 42 postdose)
  • Body mass index (weight [kilogram {kg}]/height^2 [ meter {m}]^2) between 18 and 40 kg/m^2 (inclusive), and body weight not less than 50 kg
  • Have normal renal function defined as: predicted estimated glomerular filtration rate greater than or equal to (>=) 90 milliliter (mL)/minute based on the Chronic Kidney Disease-Epidemiology formula (for participants with normal renal function)

Who cannot join

  • History of, or a reason to believe a participant has a history of, drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM V) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, opioids, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening and Day -1 of the treatment period (unless medically prescribed)
  • Any surgical or medical condition that potentially may alter the absorption, metabolism, or excretion of the study drug, with the exception of renal impairment as described in the inclusion criteria, and except for participants who had a cholecystectomy or a hernia repair
  • History of clinically significant allergies, especially known hypersensitivity or intolerances
  • Known allergy to JNJ-64565111 or its excipients
  • Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months before the first administration of study drug or intention to donate blood or blood products during the study or at least 2 months after the completion of the study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company

    Knoxville, Tennessee, 37923

  • Orlando Clinical Research Center

    Orlando, Florida, 32809

Other trials in United States

About this study

Official title: A Single-dose, Open-label, Parallel-group Study to Evaluate JNJ-64565111 Pharmacokinetics and Safety in Adult Subjects With Varying Degrees of Renal Function

The purpose of study is to evaluate the pharmacokinetics of a single, subcutaneous dose of JNJ-64565111 in adult participants with varying degrees of renal function including participants with end stage renal disease, requiring hemodialysis, compared with participants with normal renal function.

Being tested
JNJ-64565111
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.

  • JNJ-64565111Drug

    All participants will receive a single SC dose of JNJ-64565111 solution on Day 1.

Study groups in NCT03546205
Study groupRoleWhat they receive
Group 1: JNJ-64565111ExperimentalParticipants with normal renal function and no evidence of kidney damage (estimated glomerular filtration rate [eGFR] greater than or equal to [>=] 90 milliliter/minute [mL/min]) will be enrolled. Participants will receive a single subcutaneous (SC) dose of JNJ-64565111 on Day 1.
Receives: Drug: JNJ-64565111
Group 2: JNJ-64565111ExperimentalParticipants with mild renal impairment (eGFR 60 to less than [<] 90 mL/min) will be enrolled. Participants will receive a single SC dose of JNJ-64565111 on Day 1.
Receives: Drug: JNJ-64565111
Group 3: JNJ-64565111ExperimentalParticipants with moderate renal impairment (eGFR 30 to <60 mL/min) will be enrolled. Participants will receive a single SC dose of JNJ-64565111 on Day 1.
Receives: Drug: JNJ-64565111
Group 4: JNJ-64565111ExperimentalParticipants with severe renal impairment (eGFR <30 mL/min) will be enrolled. Participants will receive a single SC dose of JNJ-64565111 on Day 1.
Receives: Drug: JNJ-64565111
Group 5: JNJ-64565111ExperimentalParticipants with end-stage renal disease (requiring hemodialysis 3 times per week for at least 3 months before screening; eGFR will not be calculated) will be enrolled. Participants will receive a single SC dose of JNJ-64565111 on Day 1.
Receives: Drug: JNJ-64565111

What is being measured

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

  1. Maximum Observed Serum Analyte Concentration (Cmax) of JNJ-64565111

    Cmax is the maximum observed serum analyte concentration of JNJ-64565111.

    Measured: Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 984 hours postdose

  2. Area Under the Serum Analyte Concentration-Time Curve from Time Zero to Last Measurable (not Below Quantification Limit) Concentration (AUC[0-last]) of JNJ-64565111

    AUC [0-Last] is the area under the serum analyte concentration versus time curve from time zero to the time of the last measurable (not below quantification limit) concentration of JNJ-64565111, calculated by linear-linear trapezoidal summation.

    Measured: Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 984 hours postdose

  3. Area Under the Serum Analyte Concentration-Time Curve from Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-64565111

    AUC (0-infinity) is the area under the serum analyte concentration-time curve from time zero to infinite time, calculated as AUC(last) + C(last)/lamda(z) where C(last) is the last observed measurable (not below quantification limit) concentration of JNJ-64565111.

    Measured: Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 984 hours postdose

Secondary outcomes (2)

  1. Number of Participants with Antibodies to JNJ-64565111

    Number of participants with antibodies to JNJ-64565111 will be reported.

    Measured: Predose, Days 7, 29 and 42

  2. Number of Participants with Adverse Events

    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily have a causal relationship with the relevant investigational product.

    Measured: Approximately 9 weeks

Timeline

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

  1. First posted6 Jun 2018
  2. Study start6 Jun 2018
  3. Primary completion17 Dec 2018
  4. Study completion17 Dec 2018

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03546205
Sponsor's protocol ID
CR108474
Other IDs
64565111OBE1003
Status last verified
Apr 2025
First submitted
23 May 2018
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-64565111 in people with Kidney Failure, Chronic, run by Janssen Research & Development, LLC at 2 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 5 inclusion and 5 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 27 Apr 2025. 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 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum Observed Serum Analyte Concentration (Cmax) of JNJ-64565111 (time frame: Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 984 hours postdose). The study lists 3 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 NCT03546205.

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 27 Apr 2025.

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