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A Proof of Concept Study for a 12 Month Treatment in Patients With C3G or IC-MPGN Treated With ACH-0144471

NCT03459443 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-08-21

Study results available
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Summary

The primary purpose of this study was to evaluate the efficacy of 12 months of oral ACH-0144471 (also known as danicopan and ALXN2040) in participants with C3G or IC-MPGN based on histologic scoring and proteinuria.

Conditions

  • C3 Glomerulonephritis
  • C3 Glomerulopathy
  • Immune Complex Membranoproliferative Glomerulonephritis
  • IC-MPGN
  • Dense Deposit Disease

Interventions

DRUG

Danicopan

Danicopan was to be administered as an oral tablet.

Sponsors & Collaborators

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-20
Primary Completion
2021-03-29
Completion
2021-03-29
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Italy
  • 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 NCT03459443 on ClinicalTrials.gov