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Monoclonal Antibodies

Ravulizumab IV q8w for IgA Nephropathy (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

ICAN 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.Check my eligibility
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.See study design
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.

ICAN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 10, 26, 34,50, and 106
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 10, 26, 34,50, and 106 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 more

Side effects data

From 2022 Phase 3 trial • 195 Patients • NCT03056040
31%
Headache
30%
Nasopharyngitis
28%
Upper respiratory tract infection
21%
Fatigue
19%
Diarrhoea
19%
Pyrexia
18%
Nausea
17%
Cough
15%
Abdominal pain
14%
Back pain
14%
Dizziness
13%
Pain in extremity
11%
Arthralgia
11%
Influenza like illness
10%
Oropharyngeal pain
10%
Rhinitis
8%
Vomiting
8%
Abdominal pain upper
8%
Dyspnoea
8%
Urinary tract infection
8%
Anaemia
7%
Constipation
6%
Chest pain
6%
Dysphagia
5%
Gastroenteritis
5%
Pruritus
5%
Myalgia
5%
Palpitations
5%
Influenza
3%
Haemolysis
2%
Lower respiratory tract infection
2%
Haemolytic anaemia
1%
Basal cell carcinoma
1%
Hyperthermia
1%
Cholelithiasis
1%
Foot deformity
1%
Colitis
1%
Bone marrow failure
1%
Infection
1%
Pneumonia
1%
Post procedural infection
1%
Liver disorder
1%
Depression
1%
Epilepsy
1%
Respiratory failure
1%
Enteritis
1%
Pneumoperitoneum
1%
Toothache
1%
Bile duct stone
1%
Biliary colic
1%
Cholecystitis
1%
COVID-19
1%
Bacteraemia
1%
Escherichia sepsis
1%
Escherichia urinary tract infection
1%
Pneumonia bacterial
1%
Postoperative wound infection
1%
Rhinovirus infection
1%
Septic shock
1%
Ankle fracture
1%
Ligament injury
1%
Transfusion reaction
1%
Cerebrospinal fluid retention
1%
Loss of consciousness
1%
Dupuytren's contracture
1%
Intervertebral disc degeneration
1%
Osteonecrosis
1%
Ureterolithiasis
1%
Urinary retention
1%
Major depression
1%
Suicide attempt
1%
Dermal cyst
1%
Invasive papillary breast carcinoma
1%
Aplastic anaemia
1%
Breakthrough haemolysis
1%
Tibia fracture
1%
Lower limb fracture
1%
Deep vein thrombosis
1%
Endometrial cancer
1%
Lung cancer metastatic
1%
Renal cancer metastatic
1%
Seborrhoeic keratosis
1%
Pharyngitis
1%
Pneumococcal infection
1%
Liver function test increased
1%
Road traffic accident
1%
Suspected COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ravulizumab
Eculizumab

ICAN 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
2021
Completed Phase 4
~1080

Find a Location

Who is running the clinical trial?

Alexion Pharmaceuticals, Inc.Lead Sponsor
253 Previous Clinical Trials
40,732 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 potential participants currently able to apply for enrollment in this research study?

"The current information on clinicaltrials.gov shows that this particular trial is not actively seeking participants. Initial posting of the study was on April 30th, 2024, with the most recent update occurring on February 26th, 2024. It's worth noting that while this specific trial is closed for recruitment, there are a total of 508 other trials currently accepting volunteers."

Answered by AI

What are the principal goals that this medical study aims to achieve?

"The primary objective of this investigation, to be assessed from a Baseline through Week 34 timeframe, is the assessment of Glomerular Filtration Rate (eGFR) over a span of 106 weeks. Secondary endpoints encompass achieving a Reduction in 24-hour UPCR ≥ 50% compared to baseline at both Weeks 34 and 106 - evaluated solely during final analysis; tracking the Number of Participants with Composite Kidney Failure Endpoint characterized by various criteria including significant eGFR decline or initiation of dialysis - also evaluated only during final analysis; and observing Change From Baseline in eGFR at Weeks 34, "

Answered by AI

How many medical facilities are currently conducting this research trial?

"Presently, there are 134 active sites conducting this research. These sites can be found in various locations such as Sr Priest En Jarez, Araucania, Southport, and an additional 131 cities. Opting for the nearest site could reduce the need for extensive travel during your participation."

Answered by AI

Am I eligible to be a part of this medical study?

"Individuals diagnosed with Iga nephropathy and aged between 18 and 130 are eligible to enroll in the study. A total of 450 participants will be recruited for this trial."

Answered by AI

Does this research include individuals older than two decades?

"Participants aged 18 years or older but under the age of 130 are eligible for recruitment into this study."

Answered by AI

Has Ravulizumab IV q8w received FDA endorsement?

"Our team at Power has assigned a safety rating of 3 to Ravulizumab IV q8w based on the available data. This score reflects the advanced Phase 3 trial, indicating a foundation of efficacy support and extensive safety information."

Answered by AI
~313 spots leftby Feb 2026