← Back to Search

Complement Inhibitor

Danicopan for Dense Deposit Disease

Phase 2
Waitlist Available
Research Sponsored by Alexion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of initial 12-month treatment period
Awards & highlights

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.

Eligible Conditions
  • IgA Nephropathy or Immunoglobulin A Nephropathy
  • Dense Deposit Disease
  • Membranoproliferative Glomerulonephritis
  • Complement 3 Glomerulopathy
  • C3 Glomerulonephritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of initial 12-month treatment period
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of initial 12-month treatment period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline In Composite Biopsy Score At End Of Initial 12-Month Treatment Period
Participants With Reduction In Proteinuria At End Of Initial 12-Month Treatment Period
Secondary study objectives
Change From Baseline In Measured GFR At The End Of The Initial 12-Month Treatment Period
Change From Baseline In Proteinuria At End Of Initial 12-Month Treatment Period
Change From Baseline In eGFR At End Of Initial 12-Month Treatment Period
+4 more

Side effects data

From 2024 Phase 3 trial • 86 Patients • NCT04469465
11%
Headache
9%
Nausea
7%
Diarrhoea
7%
Arthralgia
5%
Vomiting
5%
Alanine aminotransferase increased
5%
Pain in extremity
5%
Pyrexia
5%
Hypertension
4%
Rhinorrhoea
4%
Constipation
4%
Aspartate aminotransferase increased
4%
Viral infection
4%
White blood cell count decreased
4%
Myalgia
4%
Haemolysis
4%
Urinary tract infection
4%
Oropharyngeal pain
2%
Anaemia
2%
Dyspepsia
2%
Discoloured vomit
2%
Peripheral swelling
2%
Febrile nonhaemolytic transfusion reaction
2%
Fatigue
2%
COVID-19
2%
Bone pain
2%
Dizziness
2%
SARS-CoV-2 test positive
2%
Hepatic function abnormal
2%
Proteinuria
2%
Abdominal discomfort
2%
Chest discomfort
2%
Upper respiratory tract infection
2%
Sinusitis
2%
Neutropenia
2%
Noninfective gingivitis
2%
Skin abrasion
2%
Post procedural diarrhoea
2%
Thoracic vertebral fracture
2%
Cellulitis
2%
Flushing
2%
Neutrophil count decreased
2%
Chromaturia
2%
Epistaxis
2%
Cough
2%
Blood pressure increased
2%
Splenomegaly
2%
Salivary gland pain
2%
Stomatitis
2%
Jaundice
2%
Lethargy
2%
Dry eye
2%
Abdominal pain upper
2%
Hypercholesterolaemia
2%
Rash maculo-papular
2%
Lymphocyte count decreased
2%
Localised infection
2%
Fall
2%
Blood bilirubin increased
2%
Platelet count decreased
2%
Sinus pain
2%
Acne
2%
Oedema peripheral
2%
Hallucination
2%
Post procedural haemorrhage
2%
Decreased appetite
2%
Liver disorder
2%
Leukopenia
2%
Flatulence
2%
Contusion
2%
Hot flush
2%
Post procedural contusion
2%
Osteoarthritis
2%
Insomnia
2%
Pancreatitis
2%
Hepatic enzyme increased
2%
Blood lactate dehydrogenase increased
2%
Cholecystitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Danicopan
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: DanicopanExperimental Treatment1 Intervention
Danicopan was to be administered to participants with C3G or IC-MPGN at a starting dose of 100 milligrams (mg) 3 times daily (TID) for the first 2 weeks, then the dosage was to be increased to 200 mg TID for the remainder of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Danicopan
2020
Completed Phase 3
~680

Find a Location

Who is running the clinical trial?

AlexionLead Sponsor
246 Previous Clinical Trials
38,549 Total Patients Enrolled
4 Trials studying Dense Deposit Disease
32 Patients Enrolled for Dense Deposit Disease
Alexion Pharmaceuticals, Inc.Lead Sponsor
259 Previous Clinical Trials
140,356 Total Patients Enrolled
4 Trials studying Dense Deposit Disease
32 Patients Enrolled for Dense Deposit Disease
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
36,635 Total Patients Enrolled
4 Trials studying Dense Deposit Disease
32 Patients Enrolled for Dense Deposit Disease
~3 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top