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Monoclonal Antibodies
Crovalimab for Atypical Hemolytic Uremic Syndrome (COMMUTE-a Trial)
Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical evidence of response to a C5 inhibitor (for Switch Cohort only)
Body weight >= 40 kg at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 9 years
Awards & highlights
COMMUTE-a Trial Summary
This trial will test if crovalimab is an effective and safe treatment for aHUS in adults and adolescents.
Who is the study for?
Adults and adolescents with atypical Hemolytic Uremic Syndrome (aHUS) who weigh at least 40 kg can join. They must be vaccinated against certain infections, agree to use contraception if applicable, and have a negative pregnancy test for females of childbearing potential. Those with prior kidney transplants due to aHUS or on stable doses of other treatments may also qualify.Check my eligibility
What is being tested?
The trial is testing Crovalimab's effectiveness and safety in treating aHUS. It will involve participants who are new to treatment, those switching from other C5 inhibitors, and individuals with specific genetic variations related to the disease.See study design
What are the potential side effects?
While not explicitly listed here, side effects could include reactions similar to other immune therapies such as infusion-related discomfort, increased risk of infections due to immunosuppression, possible allergic reactions, or complications related to the underlying condition.
COMMUTE-a Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have shown improvement with a C5 inhibitor treatment.
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I weigh at least 40 kg.
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I am vaccinated against meningitis according to my country's guidelines.
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My TMA is not well-managed after treatment with a C5 inhibitor.
COMMUTE-a Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 9 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants with complete TMA response (cTMAr)
Secondary outcome measures
Change from Baseline in Dialysis Status
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Change from Baseline in Hemoglobin
+20 moreCOMMUTE-a Trial Design
1Treatment groups
Experimental Treatment
Group I: CrovalimabExperimental Treatment1 Intervention
Participants will be enrolled in three cohorts: [1] Naive Cohort - participants who have not been previously treated with complement inhibitor therapy; [2] Switch Cohort - participants who switch to crovalimab from another C5 inhibitor and [3] C5 SNP (Single Nucleotide Polymorphism) Cohort - participants with documented C5 polymorphism.
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Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,431 Previous Clinical Trials
1,089,988 Total Patients Enrolled
1 Trials studying Atypical Hemolytic Uremic Syndrome
45 Patients Enrolled for Atypical Hemolytic Uremic Syndrome
Chugai PharmaceuticalIndustry Sponsor
95 Previous Clinical Trials
21,624 Total Patients Enrolled
1 Trials studying Atypical Hemolytic Uremic Syndrome
45 Patients Enrolled for Atypical Hemolytic Uremic Syndrome
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,860 Total Patients Enrolled
1 Trials studying Atypical Hemolytic Uremic Syndrome
45 Patients Enrolled for Atypical Hemolytic Uremic Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recently taken tranexamic acid.I will start or have started PE/PI treatment within 8 weeks before my first crovalimab dose.I have been treated with eculizumab or ravulizumab.I have shown improvement with a C5 inhibitor treatment.You have cryoglobulinemia when you are screened for the study, especially if you have recently been treated with a C5 inhibitor.I have recently received IVIg treatment.I have been on chronic dialysis or have end-stage kidney disease.I have never been treated with a complement inhibitor.I have not had a fever of 38°C or higher in the last week.You have a weakened immune system, such as a history of getting sick often.I weigh at least 40 kg.I am a woman who can have children and have a recent negative pregnancy test.I have not had a serious infection in the last 14 days.I haven't been in a drug study or taken experimental therapy in the last 28 days.My TMA is not caused by aHUS but by another specific condition.You had signs of a specific type of blood vessel problem within 28 days before starting the trial with crovalimab.I started plasma exchange or infusions less than 28 days ago (for new patients only).I have a known C5 gene variation.I am vaccinated against meningitis according to my country's guidelines.I am vaccinated against Haemophilus influenzae type B and Streptococcus pneumoniae, following my country's guidelines.You have tested positive for HIV.I had aHUS before my kidney transplant.I have had kidney disease, but not aHUS.I have a condition caused by a reaction to a medication.I have been on a stable dose of my current medication for at least 28 days before starting crovalimab.I have or had a condition like cancer, transplant, or autoimmune disease that could cause TMA.You have a positive direct Coombs test.My kidney disease is not caused by atypical HUS.I have had a Neisseria meningitidis infection in the last 6 months.My organs are failing.I have an active Hepatitis B or C infection and was recently treated with a C5 inhibitor.My TMA is not well-managed after treatment with a C5 inhibitor.
Research Study Groups:
This trial has the following groups:- Group 1: Crovalimab
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In how many different geographic areas is this study being conducted?
"There are a total of 18 hospitals recruiting for this clinical trial, which include Emory Children's Center in Atlanta, Children's Hospital Colorado in Aurora, and University Hospitals Cleveland Medical Center in Cleveland."
Answered by AI
Has this sort of research been done before?
"There are 8 ongoing clinical trials for Crovalimab across 41 countries and 90 cities. The first study began in 2016, 59 patients were enrolled by Hoffmann-La Roche during its Phase 1 & 2 stages. Since then, 0 additional trials have been completed."
Answered by AI
Are there any patients who are still eligible to participate in this research?
"This research is ongoing and actively recruiting participants, as noted on the clinicaltrials.gov website. The listing was created on October 22nd, 2021 and last updated November 16th, 2022."
Answered by AI
Has Crovalimab received approval from the Federal Drug Administration?
"Crovalimab has received a score of 3 for safety. This is because it is in Phase 3 clinical trials, which means that while there is some data supporting efficacy, there are multiple rounds of data supporting safety."
Answered by AI
Can you provide some historical context for Crovalimab's clinical trials?
"Crovalimab was first studied at Tokyo Medical University Hospital in 2016. To date, 8 live studies are ongoing with several taking place in Atlanta, Georgia."
Answered by AI
How many people are being accepted into this experiment?
"In order for this study to reach its target sample size of 90, eligible patients must be recruited from two locations: Emory Children's Center in Atlanta and Children's Hospital Colorado in Aurora."
Answered by AI
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