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A Study to Evaluate JNJ-64565111 Pharmacokinetics and Safety in Adult Participants With Varying Degrees of Renal Function | Clinical Trials | Clareo Health

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

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

NCT03546205•Janssen Research & Development, LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 79 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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)
•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

Exclusion Criteria

•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)

Locations (2)

Orlando Clinical Research Center

Orlando, Florida, United States

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

Knoxville, Tennessee, United States

Key Dates

Start Date

June 6, 2018

Primary Completion Date

December 17, 2018

Completion Date

December 17, 2018

Last Updated

April 27, 2025

Enrollment

ACTUAL participants

Conditions

Kidney Failure, Chronic

Interventions

JNJ-64565111

DRUG

First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients

NCT06314503

Renal Insufficiency, ChronicKidney Failure, Chronic+1 more

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RECRUITINGNA

Effects of Royal Jelly Supplementation in Chronic Kidney Disease

NCT06438445

Kidney Failure, ChronicOxidative Stress+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients

Effects of Royal Jelly Supplementation in Chronic Kidney Disease

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DePTH: De-emphasize PTH

Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant