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Monoclonal Antibodies
Ravulizumab for Kidney Disease (ICAN Trial)
Phase 3
Recruiting
Research Sponsored by Alexion 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 baseline, weeks 10, 26, 34,50, and 106
Awards & highlights
Pivotal Trial
Summary
"This trial aims to see if a drug called ravulizumab can help reduce protein in the urine and slow down kidney function decline in adults with IgA nephropathy at risk of their condition
Who is the study for?
This trial is for adults with IgA Nephropathy, a kidney disease causing protein in urine and kidney function decline. Participants should be at risk of their condition getting worse.
What is being tested?
The study tests if Ravulizumab can better reduce proteinuria (protein in urine) and slow down the loss of kidney function compared to a placebo in patients with IgAN.
What are the potential side effects?
Ravulizumab may cause headaches, nausea, high blood pressure, fever, or interfere with normal immune responses leading to increased infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, weeks 10, 26, 34,50, and 106
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 10, 26, 34,50, and 106
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 Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Week 34
Glomerular Filtration Rate (eGFR) Over 106 Weeks
Secondary study objectives
Change From Baseline in Albuminuria Based on Urine Albumin to Creatinine Ratio (UACR) at Weeks 10, 26, 34, 50, and 106
Change From Baseline in eGFR at Weeks 34, 50, and 106
Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Weeks 34, 50, and 106
+6 moreSide effects data
From 2022 Phase 4 trial • 18 Patients • NCT0432060233%
Fatigue
17%
Abdominal pain
17%
COVID-19
17%
SARS-CoV-2 test positive
17%
Cough
11%
Back pain
11%
Nasopharyngitis
11%
Non-cardiac chest pain
11%
Dyspnoea
6%
Pain
6%
Pain in extremity
6%
Chest discomfort
6%
Body temperature abnormal
6%
Rash
6%
Herpes zoster
6%
Upper respiratory tract congestion
6%
Arthralgia
6%
Peripheral swelling
6%
Influenza like illness
6%
Pneumonia
6%
Asthenia
6%
Retinal haemorrhage
6%
Headache
6%
Haemoglobinuria
6%
Neurodermatitis
6%
Pyrexia
6%
Skin lesion
6%
Nephrolithiasis
6%
Upper respiratory tract infection
6%
Urinary tract infection
6%
Constipation
6%
Extravascular haemolysis
6%
Haemoglobin decreased
6%
Oropharyngeal pain
6%
Nail ridging
6%
Chromaturia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ravulizumab
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ravulizumab IV q8wExperimental Treatment1 Intervention
Participants will receive a weight-based loading dose on Day 1 followed by weight-based maintenance dosing initiated on Day 15, and then administered every 8 weeks (q8w).
Participants in the exploratory group will receive open-label weight based loading dose on Day 1 followed by open label weight based maintenance dose on Day 15 and q8weeks after.
Group II: Placebo IV q8wPlacebo Group1 Intervention
Participants will receive a weight-based loading dose on Day 1 followed by weight-based maintenance dosing initiated on Day 15, and then administered q8w.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ravulizumab
2016
Completed Phase 4
~1090
Find a Location
Who is running the clinical trial?
Alexion Pharmaceuticals, Inc.Lead Sponsor
262 Previous Clinical Trials
140,036 Total Patients Enrolled