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NCT04935294 · ClinicalTrials.gov registry record · Phase 1
Study of Danicopan in Participants With Normal Kidney Function and Participants With Kidney Dysfunction
A Phase 1 study of Healthy and Renal Dysfunction, sponsored by Alexion Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 4
- Study locations
NCT04935294: Completed Phase 1 study of Healthy and Renal Dysfunction, sponsored by Alexion Pharmaceuticals.
NCT04935294 is a Phase 1 study of Healthy and Renal Dysfunction that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 16 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04935294, a Phase 1 study of Healthy and Renal Dysfunction, has completed, sponsored by Alexion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 4
- Study locations
Study Summary
This was an open-label, nonrandomized, multi-center, single-dose, parallel group study to evaluate the effect of severe renal impairment (RI) on the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan (ACH-0144471) compared to demographically-matched healthy participants with normal renal function.
Conditions Studied
Interventions
- DRUG Danicopan
Study Locations (4)
Florida
- Clinical Trial Site - Miami
- Clinical Trial Site - Orlando
Minnesota
- Clinical Trial Site - Minneapolis
- Clinical Trial Site - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-01-24 |
| Est. Completion | 2018-05-29 |
| Phase | Phase 1 |
What the finished NCT04935294 record still lists
NCT04935294 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Danicopan is the first listed.
NCT04935294 reports a single indexed study location in Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT04935294 about?
NCT04935294 is a clinical study titled "Study of Danicopan in Participants With Normal Kidney Function and Participants With Kidney Dysfunction". This was an open-label, nonrandomized, multi-center, single-dose, parallel group study to evaluate the effect of severe renal impairment (RI) on the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan (ACH-0144471) compared to demographically-matched healthy participants with n...
What is the current status of trial NCT04935294?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2018-01-24. Estimated completion is 2018-05-29.
What conditions does trial NCT04935294 study?
This clinical trial studies the following conditions: Healthy, Renal Dysfunction.
What interventions are being tested in trial NCT04935294?
The interventions under investigation include: Danicopan (DRUG).
Who is sponsoring clinical trial NCT04935294?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04935294 being conducted?
This trial has 4 study locations across Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
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 NCT04935294's enrollment target sits among peer trials
16 936th of 1090 higher than 137 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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