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Monoclonal Antibodies

Ravulizumab for Atypical Hemolytic Uremic Syndrome

Phase 3
Waitlist Available
Research Sponsored by Alexion Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 26 and week 52
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective in treating people with aHUS who have not tried a complement inhibitor before.

Eligible Conditions
  • Atypical Hemolytic Uremic Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 26 and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 26 and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Thrombotic Microangiopathies
Secondary outcome measures
Change From Baseline In Estimated Glomerular Filtration Rate (eGFR) At Weeks 26 and 52
Change From Baseline In Hemoglobin At Weeks 26 and 52
Lactate Dehydrogenase
+8 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%
Hyperthermia
1%
Cholelithiasis
1%
Foot deformity
1%
Basal cell carcinoma
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: RavulizumabExperimental Treatment1 Intervention
Participants were administered weight-based doses of ravulizumab every 8 weeks for 26 weeks in the Initial Evaluation Period. After the Initial Evaluation Period, participants could enter an Extension Period and receive ravulizumab until the product registration or approval (in accordance with country-specific regulations) or for up to 4.5 years, whichever occurs first.
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
252 Previous Clinical Trials
41,084 Total Patients Enrolled
16 Trials studying Atypical Hemolytic Uremic Syndrome
3,707 Patients Enrolled for Atypical Hemolytic Uremic Syndrome
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,355 Total Patients Enrolled
14 Trials studying Atypical Hemolytic Uremic Syndrome
3,382 Patients Enrolled for Atypical Hemolytic Uremic Syndrome
AlexionLead Sponsor
246 Previous Clinical Trials
39,209 Total Patients Enrolled
15 Trials studying Atypical Hemolytic Uremic Syndrome
3,407 Patients Enrolled for Atypical Hemolytic Uremic Syndrome

Frequently Asked Questions

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

What are the most similar studies to this one that have been conducted in the past?

"5 Ravulizumab trials have completed since 2016, with the most recent one finishing its Phase 3 drug approval stage. Currently, there are 16 live studies for Ravulizumab across 193 cities and 31 countries."

Answered by AI

Are there any previous findings with Ravulizumab?

"Since 2016, ravulizumab has been studied in 5 completed trials at the Clinical Trial Site. Currently, there are 16 active studies underway with many of them based in Winston-Salem, North carolina."

Answered by AI

Are there any short or long-term risks to taking Ravulizumab?

"There is some evidence that ravulizumab is effective, and as it is a phase 3 trial, there is also data backing its safety--both of which resulted in a score of 3."

Answered by AI

What medical conditions does Ravulizumab commonly treat?

"Ravulizumab is an effective treatment for patients experiencing disease activity, hemolysis, and thrombotic microangiopathies."

Answered by AI
Recent research and studies
BMC NephrologyJournal
Efficacy and Safety of the Long-acting C5 Inhibitor Ravulizumab in Patients with Atypical Hemolytic Uremic Syndrome Triggered by Pregnancy: A Subgroup Analysis
Gäckler, Anja, Ulf Schönermarck, Vladimir Dobronravov, Gaetano La Manna, Andrew Denker, Peng Liu, Maria Vinogradova, Sung-Soo Yoon, and Manuel Praga. 2021. “Efficacy and Safety of the Long-acting C5 Inhibitor Ravulizumab in Patients with Atypical Hemolytic Uremic Syndrome Triggered by Pregnancy: A Subgroup Analysis”. BMC Nephrology. Springer Science and Business Media LLC. doi:10.1186/s12882-020-02190-0.
Kidney International ReportsJournal
Long-term Efficacy and Safety of the Long-acting Complement C5 Inhibitor Ravulizumab for the Treatment of Atypical Hemolytic Uremic Syndrome in Adults
Barbour, Thomas, Marie Scully, Gema Ariceta, Spero Cataland, Katherine Garlo, Nils Heyne, Yosu Luque, et al.. 2021. “Long-term Efficacy and Safety of the Long-acting Complement C5 Inhibitor Ravulizumab for the Treatment of Atypical Hemolytic Uremic Syndrome in Adults”. Kidney International Reports. Elsevier BV. doi:10.1016/j.ekir.2021.03.884.
clinicaltrials.govStudy
Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
2017. "Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02949128.
~7 spots leftby Apr 2025
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