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NCT04699656 · ClinicalTrials.gov registry record · Phase 1
Plazomicin Study in ESRD Patients Receiving IHD
A Phase 1 study of End Stage Renal Disease, sponsored by Cipla USA.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT04699656: Completed Phase 1 study of End Stage Renal Disease, sponsored by Cipla USA.
NCT04699656 is a Phase 1 study of End Stage Renal Disease that has completed, run by Cipla USA. The registered enrollment target is 6 participants, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04699656, a Phase 1 study of End Stage Renal Disease, has completed, sponsored by Cipla USA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is being conducted to directly characterize the pharmacokinetic (PK) profile of plazomicin following administration of a single oral dose before and after IHD in subjects with ESRD. This PK assessment will be used to provide appropriate plazomicin dosing recommendations for patients with ESRD receiving IHD.
Primary Outcome
Plasma PK parameter for plazomicin before and after IHD
Conditions Studied
Interventions
- DRUG Plazomicin Injection
Study Locations (1)
Florida
- Orlando Clinical Research Center - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-01-05 |
| Est. Completion | 2021-06-09 |
| Phase | Phase 1 |
What the finished NCT04699656 record still lists
NCT04699656 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (99% lower).
The record links to 1 condition, with End Stage Renal Disease appearing as the primary indexed condition, and to 1 intervention - of which Plazomicin Injection is the first listed.
NCT04699656 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT04699656 about?
NCT04699656 is a clinical study titled "Plazomicin Study in ESRD Patients Receiving IHD". This study is being conducted to directly characterize the pharmacokinetic (PK) profile of plazomicin following administration of a single oral dose before and after IHD in subjects with ESRD. This PK assessment will be used to provide appropriate plazomicin dosing recommendations for patients with ...
What is the current status of trial NCT04699656?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2021-01-05. Estimated completion is 2021-06-09.
What conditions does trial NCT04699656 study?
This clinical trial studies the following conditions: End Stage Renal Disease.
What interventions are being tested in trial NCT04699656?
The interventions under investigation include: Plazomicin Injection (DRUG).
Who is sponsoring clinical trial NCT04699656?
This trial is sponsored by Cipla USA, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04699656 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04699656's enrollment target sits among peer trials
6 86th of 86 higher than 1 of 86 other End Stage Renal Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other End Stage Renal Disease 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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