A Proof-of-Mechanism Study to Determine the Effect of Danicopan on C3

Updated 04/16/2024

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

C3 Glomerulonephritis
C3 Glomerulopathy
Dense Deposit Disease
Glomerulonephritis
Glomerulonephritis, Membranoproliferative
Immune Complex Mediated Membranoproliferative Glomerulonephritis

Clinical Trial Details

NCT number	NCT03124368
Study type	Interventional
Source	Alexion Pharmaceuticals
Contact
Status	Completed
Phase	Phase 2
Start date	August 9, 2017
Completion date	January 9, 2019

See also
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	Not yet recruiting	`NCT05647811` - Study of NM8074 in Adult C3 Glomerulopathy Patients	Phase 1/Phase 2
	Active, not recruiting	`NCT05067127` - Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis	Phase 3
	Active, not recruiting	`NCT05809531` - An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis	Phase 3
	Terminated	`NCT03459443` - A Proof of Concept Study for a 12 Month Treatment in Patients With C3G or IC-MPGN Treated With ACH-0144471	Phase 2
	Completed	`NCT03369236` - A Proof-of-Concept Study of Danicopan for 6 Months of Treatment in Participants With C3 Glomerulopathy (C3G)	Phase 2
	Not yet recruiting	`NCT06209736` - Safety and Efficacy Study of OMS906 in Patients With C3G and ICGN	Phase 2
	Active, not recruiting	`NCT04572854` - Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN	Phase 2
	Recruiting	`NCT02682407` - Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721	Phase 2
	Recruiting	`NCT05083364` - Study of ARO-C3 in Adult Healthy Volunteers and Patients With Complement Mediated Renal Disease	Phase 1
	Completed	`NCT03723512` - Non-contrast Enhanced MRI in Patients With C3 Glomerulopathy (C3G) or Immune-complex Membranoproliferative Glomerulonephritis (IC-MPGN) Enrolled in the ACH471-205 Study	N/A
	Available	`NCT04729062` - C3G/Primary IC-MPGN EAP