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A Proof-of-Mechanism Study to Determine the Effect of Danicopan on C3 Levels in Participants With C3G or IC-MPGN

NCT03124368 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-11-04

Study results available
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Summary

The primary objective of this study was to determine whether ACH-0144471 (also known as danicopan and ALXN2040) increases blood C3 complement protein (C3) levels in participants with low C3 levels due to either C3G or IC-MPGN.

Conditions

  • C3 Glomerulonephritis
  • Dense Deposit Disease
  • C3 Glomerulopathy
  • Immune Complex Mediated Membranoproliferative Glomerulonephritis
  • Membranoproliferative Glomerulonephritis Types I, II, and III

Interventions

DRUG

Danicopan

Participants received study drug for 14 days (Treatment Period), followed by a taper over the next 7 days (Taper Period).

Sponsors & Collaborators

  • Achillion, a wholly owned subsidiary of Alexion

    collaborator INDUSTRY

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-09
Primary Completion
2018-12-21
Completion
2019-01-09
FDA Drug
Yes

Countries

  • Australia
  • Belgium
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03124368 on ClinicalTrials.gov