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Complement Inhibitor

Iptacopan for Complement 3 Glomerulopathy (APPEAR-C3G Trial)

Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of C3G as confirmed by renal biopsy within 12 months prior to enrollment in adults and within 3 years in adolescents
Male and female participants age ≥ 12 and ≤ 60 years at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6, month 12 (open-label)
Awards & highlights

APPEAR-C3G Trial Summary

This trial will study whether a new drug, iptacopan, is effective and safe for treating complement 3 glomerulopathy, a kidney disease. The trial will be conducted at multiple centers, with patients randomly assigned to receive either the drug or a placebo. The trial will be double-blind, meaning neither the patients nor the study staff will know who is receiving the drug or the placebo.

Who is the study for?
This trial is for people aged 12-60 with C3 Glomerulopathy confirmed by a kidney biopsy. They must have low serum C3 levels, been on certain blood pressure medications for at least 90 days, and show specific urine protein levels. Participants need functioning kidneys and vaccinations against certain infections.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of iptacopan compared to a placebo in treating Complement 3 Glomerulopathy. It's randomized, meaning participants are put into the iptacopan or placebo group by chance, double-blind so neither researchers nor participants know who gets what treatment.See study design
What are the potential side effects?
While not specified here, common side effects of drugs like iptacopan may include headache, nausea, diarrhea or constipation. More serious risks could involve allergic reactions or potential impact on immune system function.

APPEAR-C3G Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My kidney disease (C3G) was confirmed by a biopsy recently.
Select...
I am between 12 and 60 years old.
Select...
I have been vaccinated against meningitis, and if possible, pneumonia and Haemophilus influenzae.
Select...
My kidney function, measured by GFR, is at least 30 ml/min/1.73m2.
Select...
I am between 18 and 60 years old.

APPEAR-C3G Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6, month 12 (open-label)
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6, month 12 (open-label) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adolescent cohort: Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection)
Adult cohort: Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection)
Change from baseline in log-transformed UPCR at the 12-month visit (both study treatment arms).
+1 more
Secondary outcome measures
Adult cohort: Change from baseline in disease total activity score in a renal biopsy.
Change from baseline in eGFR.
Change from baseline in the FACIT-Fatigue score at 12 months
+8 more

Side effects data

From 2022 Phase 2 trial • 16 Patients • NCT03439839
30%
Pyrexia
20%
Asthenia
20%
Rhinorrhoea
20%
Thrombocytopenia
20%
Anaemia
20%
Foot fracture
20%
Dysuria
20%
Back pain
20%
Rhinitis
20%
Hypertriglyceridaemia
20%
Headache
20%
Diarrhoea
20%
Nasopharyngitis
20%
Insomnia
10%
Cough
10%
Nausea
10%
Medical device site irritation
10%
Abdominal pain upper
10%
Vulvovaginal dryness
10%
Aphthous ulcer
10%
Vaginal infection
10%
Nocturia
10%
Vomiting
10%
Oedema peripheral
10%
Penetrating aortic ulcer
10%
Andropause
10%
Medical device site pain
10%
Non-cardiac chest pain
10%
Abdominal pain
10%
Dysmenorrhoea
10%
Hepatic cytolysis
10%
Hyperferritinaemia
10%
Pruritus
10%
Nightmare
10%
Contusion
10%
Pollakiuria
10%
Vaccination complication
10%
Haematospermia
10%
Hyperuricaemia
10%
Flushing
10%
Hot flush
10%
Ear infection
10%
Actinic keratosis
10%
Alopecia
10%
Influenza
10%
Periodontitis
10%
Chest pain
10%
Musculoskeletal chest pain
10%
Breast pain
10%
Blood creatine phosphokinase increased
10%
Escherichia bacteraemia
10%
Lymphoproliferative disorder
10%
COVID-19
10%
Squamous cell carcinoma of the tongue
10%
Hypercholesterolaemia
10%
Haemorrhage intracranial
10%
Herpes zoster
10%
Oral herpes
10%
Joint swelling
10%
Genital discomfort
10%
Angiofibroma
10%
Dermatitis acneiform
10%
Weight decreased
10%
Basal cell carcinoma
10%
Dysphagia
10%
Spinal pain
10%
Migraine
10%
Squamous cell carcinoma of the oral cavity
10%
Tongue ulceration
10%
Vitamin B12 deficiency
10%
Arthralgia
10%
Pyelonephritis
10%
Ocular icterus
10%
Fungal skin infection
10%
Paraesthesia
10%
Poor quality sleep
10%
Upper respiratory tract congestion
10%
Dyspnoea exertional
10%
Petechiae
10%
Ecchymosis
10%
Psoriasis
10%
Eczema
10%
Onycholysis
10%
Haematoma
10%
Dry skin
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: LNP023 200mg Bid + SoC
Cohort 2: LNP023 50mg Bid + SoC
Cohort 2: LNP023 200mg Bid + SoC
Total

APPEAR-C3G Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: iptacopan 200mgExperimental Treatment1 Intervention
iptacopan 200 mg b.i.d.
Group II: Placebo to iptacopan 200mgPlacebo Group1 Intervention
Placebo to iptacopan 200mg b.i.d.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
iptacopan
2018
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,859 Previous Clinical Trials
4,198,275 Total Patients Enrolled

Media Library

Iptacopan (Complement Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04817618 — Phase 3
Complement 3 Glomerulopathy Research Study Groups: iptacopan 200mg, Placebo to iptacopan 200mg
Complement 3 Glomerulopathy Clinical Trial 2023: Iptacopan Highlights & Side Effects. Trial Name: NCT04817618 — Phase 3
Iptacopan (Complement Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04817618 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study include any participants who are over the age of 65?

"This clinical trial is interested in enrolling participants who are over 18 and younger than 60."

Answered by AI

Are new participants being allowed into this research project?

"That is correct, the online information indicates that this research project is still recruiting individuals. The trial was initially posted on July 28th, 2021 and has since been updated on November 9th, 2022. There are 68 spots available at 9 different locations."

Answered by AI

Does this research project have a presence in more than one location within the city?

"9 medical facilities are currently running this clinical trial. If you choose to participate in the study, selecting a location close to you will minimize travel requirements. The locations include Albany, Aurora and Boston as well 9 other cities."

Answered by AI

Could you please list other iptacopan-based research projects?

"In 2019, the first iptacopan study was completed at Novartis Investigative Site. Since then, there have been a total of 18282 studies. Out of these, 10 are ongoing with most taking place in Albany, New york."

Answered by AI

To what kind of people does this study apply?

"C3G positive individuals between the age of majority and 60 years old are eligible to apply for this clinical trial. Up to 68 subjects are needed for this study."

Answered by AI

What is the status of iptacopan's FDA approval process?

"Iptacopan's safety is estimated to be a 3. This score was given because iptacopan has progressed to Phase 3 clinical trials, meaning that there is supportive data for both efficacy and safety."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
2021. "Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04817618.
~34 spots leftby Mar 2026
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