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NCT03546205 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Kidney Failure, Chronic, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 1
Development phase
40
Enrollment target
2
Study locations

NCT03546205 is a Phase 1 study of Kidney Failure, Chronic that has completed, run by Janssen Research & Development. The registered enrollment target is 40 participants, below the 330-participant average among 23 other Kidney Failure, Chronic trials with a reported enrollment target (88% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT03546205, a Phase 1 study of Kidney Failure, Chronic, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target
2
Study locations

Study 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.

Conditions Studied

Interventions

  • DRUG JNJ-64565111

Study Locations (2)

Florida

  • Orlando Clinical Research Center - Orlando

Tennessee

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

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2018-06-06
Est. Completion 2018-12-17
Phase Phase 1

Sponsor

Janssen Research & Development

593 total trials

What the Registry Record Tells You About NCT03546205

The ClinicalTrials.gov registry entry for NCT03546205 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 330-participant average among 23 other Kidney Failure, Chronic trials with a reported enrollment target (88% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Kidney Failure, Chronic appearing as the primary indexed condition, and to 1 intervention - of which JNJ-64565111 is the first listed.

NCT03546205 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Florida, Tennessee.

Frequently Asked Questions

What is clinical trial NCT03546205 about?

NCT03546205 is a clinical study titled "A Study to Evaluate JNJ-64565111 Pharmacokinetics and Safety in Adult Participants 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.

What is the current status of trial NCT03546205?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2018-06-06. Estimated completion is 2018-12-17.

What conditions does trial NCT03546205 study?

This clinical trial studies the following conditions: Kidney Failure, Chronic.

What interventions are being tested in trial NCT03546205?

The interventions under investigation include: JNJ-64565111 (DRUG).

Who is sponsoring clinical trial NCT03546205?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03546205 being conducted?

This trial has 2 study locations across Florida, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.