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Complement Inhibitor

APL-2 for Glomerulopathies

Phase 2
Waitlist Available
Research Sponsored by Apellis Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have stable or worsening renal disease, on stable and optimized treatment, in the opinion of the PI, for at least 2 months prior to the first dose of APL-2 (Visit 4); treatments may include, but are not limited to, immunosuppressive agents, anti-hypertensives and/or anti-proteinurics
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Awards & highlights

Study Summary

This trial is testing a new treatment for patients with glomerulopathies, a type of kidney disease. The treatment is given as a daily infusion, and the trial will last for 16 weeks with a follow-up period of 6 months.

Eligible Conditions
  • C3 Glomerulonephritis
  • Dense Deposit Disease
  • Membranous Glomerulonephritis
  • Immunoglobulin A Nephropathy
  • Lupus Nephritis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have kidney disease that is not getting better and have been on a stable treatment for at least 2 months before starting the study. This treatment may include medicines that lower blood pressure or reduce the amount of protein in the urine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proteinuria
Secondary outcome measures
Changes of Disease Specific Biomarkers (serum C3 levels, AH50 and C3a concentrations, serum albumin levels)
Complete clinical remission defined as normalization of proteinuria as defined by <200 mg/g uPCR at Week 48
Stabilization or improvement in estimated Glomerular Filtration Rate (eGFR) from baseline to Week 48

Side effects data

From 2021 Phase 3 trial • 53 Patients • NCT04085601
13%
Pain in extremity
13%
Hypokalaemia
11%
Arthralgia
11%
Dizziness
9%
Pyrexia
9%
Headache
7%
Thrombocytopenia
7%
Ecchymosis
7%
Erythema
7%
Viral infection
7%
Anaemia
7%
Haemolysis
7%
Musculoskeletal pain
7%
Abdominal pain
7%
Abdominal pain upper
7%
Cough
7%
Epistaxis
7%
Somnolence
7%
Blood creatinine increased
2%
Rhinitis allergic
2%
Febrile neutropenia
2%
Neutropenia
2%
Pancytopenia
2%
Dermoid cyst
2%
Bile duct stone
2%
Septic shock
2%
Fatigue
2%
Upper respiratory tract infection
2%
Hyperuricaemia
2%
Dyspepsia
2%
Dyspnoea
2%
Oropharyngeal discomfort
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Pegcetacoplan
Standard of Care

Trial Design

1Treatment groups
Experimental Treatment
Group I: APL-2Experimental Treatment1 Intervention
Open Label, Study Drug, APL-2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pegcetacoplan
FDA approved

Find a Location

Who is running the clinical trial?

Apellis Pharmaceuticals, Inc.Lead Sponsor
24 Previous Clinical Trials
4,004 Total Patients Enrolled
3 Trials studying Dense Deposit Disease
190 Patients Enrolled for Dense Deposit Disease

Media Library

APL-2 (Complement Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03453619 — Phase 2
Dense Deposit Disease Research Study Groups: APL-2
Dense Deposit Disease Clinical Trial 2023: APL-2 Highlights & Side Effects. Trial Name: NCT03453619 — Phase 2
APL-2 (Complement Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03453619 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Mar 2025