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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
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
- Membranous Glomerulonephritis
- Immunoglobulin A Nephropathy
- C3 Glomerulonephritis
- Dense Deposit Disease
- Lupus Nephritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
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 • NCT0408560113%
Pain in extremity
13%
Hypokalaemia
11%
Arthralgia
11%
Dizziness
9%
Pyrexia
9%
Headache
7%
Ecchymosis
7%
Thrombocytopenia
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%
Dyspnoea
2%
Bile duct stone
2%
Septic shock
2%
Oropharyngeal discomfort
2%
Rhinitis allergic
2%
Fatigue
2%
Febrile neutropenia
2%
Neutropenia
2%
Pancytopenia
2%
Dermoid cyst
2%
Upper respiratory tract infection
2%
Hyperuricaemia
2%
Dyspepsia
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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have had a previous biopsy and the results should show specific staining for C3 and C4d.You have kidney biopsy results showing specific types of lesions, or have evidence of kidney disease activity in the last 6 months.Your liver enzymes (ALT or AST) are more than 3 times the normal level during the screening visits.You have been treated with APL-2 before.You have had a solid organ transplant in the past.You have HIV, hepatitis B, or hepatitis C infection, or tested positive for these viruses during screening. If you had hepatitis B or C in the past but it was treated and cleared, you may still be eligible.Your kidney disease is caused by another health problem or medication.You have a current or suspected serious bacterial or viral infection, or a history of frequent serious bacterial infections.You don't want to receive injections under the skin or are allergic to the ingredients in APL-2.You must have a confirmed diagnosis of a specific kidney disease after a kidney biopsy.Your absolute neutrophil count is less than 1000 cells/mm3 during specific screening visits.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.You have a specific type of kidney disease called primary membranous nephropathy with high levels of protein in your urine.You have a kidney condition called C3G and either low levels of C3 in your blood or had a kidney biopsy in the last 3 years.You have a high level of protein in your urine, measured during the first screening visit.Your kidney function is good, and you are not currently on dialysis.
Research Study Groups:
This trial has the following groups:- Group 1: APL-2
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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