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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: Completed Phase 1 study of Kidney Failure, Chronic, sponsored by Janssen Research & Development.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cmax is the maximum observed serum analyte concentration of JNJ-64565111.
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
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-06-06 |
| Est. Completion | 2018-12-17 |
| Phase | Phase 1 |
What the finished NCT03546205 record still lists
NCT03546205 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 330-participant average among 23 other Kidney Failure, Chronic trials with a reported enrollment target (88% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Kidney Failure, Chronic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03546205's enrollment target sits among peer trials
40 14th of 23 higher than 10 of 23 other Kidney Failure, Chronic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Failure, Chronic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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