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Complement Inhibitor

iptacopan 200mg b.i.d for IgA Nephropathy or Immunoglobulin A Nephropathy (APPARENT 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
Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of an ACEI or ARB for at least 90 days (or as according to local guidelines). The doses of other drugs administered to reduce proteinuria and control the disease including mycophenolic acids (MPAs - mycophenolate mofetil or mycophenolate sodium), corticosteroids, SGLT2 inhibitors and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization
If not previously vaccinated, or if a booster is required, vaccination against Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to the first study treatment administration. If the study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated in accordance with local standard of care.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months of double-blind & 6 months of open label (up to 12 months)
Awards & highlights

APPARENT Trial Summary

This trial will study how a drug called iptacopan affects a kidney condition called idiopathic membranoproliferative glomerulonephritis.

Who is the study for?
This trial is for people aged 12-60 with a specific kidney disease called IC-MPGN, confirmed by biopsy. Participants must have been on certain medications like ACEI or ARB for at least 90 days and have stable doses of other drugs to control protein in urine. They need a minimum kidney function level and vaccinations against specific infections before starting the study.Check my eligibility
What is being tested?
The study tests iptacopan's effectiveness and safety compared to a placebo in treating IC-MPGN. It's conducted across multiple centers where participants are randomly assigned to either receive iptacopan or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
While the side effects of iptacopan aren't detailed here, common ones may include reactions at the injection site, gastrointestinal issues, potential impact on immune response due to its mechanism of action, and possibly others as observed during the trial.

APPARENT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on the highest dose possible of ACEI or ARB for at least 90 days.
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I have been vaccinated against Haemophilus influenzae or will start antibiotics if I must begin treatment sooner.
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I am between 12 and 60 years old.
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My kidney function is at a safe level for the trial.

APPARENT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months of double-blind & 6 months of open label (up to 12 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months of double-blind & 6 months of open label (up to 12 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Log-transformed ratio to 6-month visit in UPCR at the 12-month visit in the placebo arm.
Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) at 6 months.
Log-transformed ratio to baseline in UPCR at the 12-month visit (both study treatment arms)
Secondary outcome measures
Change from baseline in eGFR
Change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score.
Change in eGFR from the 6-month visit to the 12- month visit of the placebo arm
+6 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%
Andropause
10%
Medical device site pain
10%
Non-cardiac chest pain
10%
Abdominal pain
10%
Dysmenorrhoea
10%
Penetrating aortic ulcer
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

APPARENT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: iptacopan 200mg b.i.dExperimental Treatment1 Intervention
iptacopan 200mg b.i.d
Group II: Placebo to iptacopan 200mg b.i.d.Placebo 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
2,860 Previous Clinical Trials
4,198,241 Total Patients Enrolled

Frequently Asked Questions

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

Are there remaining vacancies in this research project?

"Affirmative. According to the clinicaltrials.gov website, this study is actively enrolling patients as of December 13th 2023 and began recruiting on October 2nd 2023. The medical trial requires a total of 68 participants distributed across 16 different sites."

Answered by AI

Which individuals are eligible to participate in this investigation?

"To participate in this medical trial, participants must have iga nephropathy or immunoglobulin a nephropathy and lie between 12-60 years of age. 68 candidates are being sought out for the study."

Answered by AI

Is this clinical trial open to persons of advanced age?

"This study accepts patients aged 12 to 60 years old. Additionally, there are 6 trials available for minors and 5 studies open for seniors over 65."

Answered by AI

What is the patient population size for this clinical experiment?

"Affirmative. Evidence from clinicaltrials.gov shows that this investigation is currently enlisting participants, with the initial posting being on October 2nd 2023 and the last update taking place on December 13th 2023. A total of 68 volunteers are necessary to be recruited across 16 medical sites."

Answered by AI

Are there any healthcare facilities in Canada conducting this investigation?

"16 trial sites have been selected for this medical study, with 3 of them based in Okayama-city, Boston and New york. It is advisable to pick a centre that's conveniently located near you if you choose to join the research project, so as to reduce travel inconveniences."

Answered by AI

Has the FDA given their stamp of approval to iptacopan 200mg twice daily?

"Our team at Power has rated iptacopan 200mg b.i.d as a 3 on our safety scale, which is indicative of the drug's Phase 3 status and plentiful evidence for both efficacy and safety from prior trials."

Answered by AI

What aims does this trial seek to accomplish?

"The chief outcome of this medical trial, assessed over a 12-month period, is the log-transformed ratio to baseline in UPCR (sampled from 24 hours' urination collection) at 6 months. Secondary objectives include appraising the efficacy of iptacopan on a composite renal endpoint as opposed to placebo at six and twelve months; assessing the potential for improvement in eGFR outcomes between 6 and 12 month visits within the placebo arm; concluding superiority of iptacopan versus placebo by evaluating proportion patients who achieved a composite renal endpoint."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN
2023. "Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05755386.
~45 spots leftby Oct 2026
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