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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

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

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 more

Side effects data

From 2022 Phase 4 trial • 18 Patients • NCT04320602

33%

Fatigue

17%

Abdominal pain

17%

SARS-CoV-2 test positive

17%

Cough

17%

COVID-19

11%

Back pain

11%

Nasopharyngitis

11%

Non-cardiac chest pain

11%

Dyspnoea

Pain

Chest discomfort

Rash

Body temperature abnormal

Herpes zoster

Nail ridging

Arthralgia

Peripheral swelling

Influenza like illness

Pneumonia

Asthenia

Retinal haemorrhage

Headache

Pain in extremity

Haemoglobinuria

Neurodermatitis

Skin lesion

Chromaturia

Nephrolithiasis

Pyrexia

Upper respiratory tract infection

Urinary tract infection

Constipation

Extravascular haemolysis

Haemoglobin decreased

Upper respiratory tract congestion

Oropharyngeal pain

100%

80%

60%

40%

20%

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

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