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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 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.

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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.

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

FieldValue
Enrollment Target 16 participants
Start Date 2018-01-24
Est. Completion 2018-05-29
Phase Phase 1

Sponsor

Alexion Pharmaceuticals

162 total trials

What the Registry Record Tells You About NCT04935294

The ClinicalTrials.gov registry entry for NCT04935294 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The listed sponsor is Alexion Pharmaceuticals, which has 162 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 2 distinct geographic areas - top geographies include 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.

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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.