Crovalimab for Atypical Hemolytic Uremic Syndrome
(COMMUTE-a Trial)
Recruiting in Palo Alto (17 mi)
+108 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Hoffmann-La Roche
Must be taking: C5 inhibitors
Must not be taking: Tranexamic acid, IVIg
Disqualifiers: Non-aHUS renal disease, HIV, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial aims to test the effectiveness and safety of crovalimab in adults and adolescents with aHUS. Crovalimab helps by calming an overactive immune system that can harm blood vessels and kidneys.
Will I have to stop taking my current medications?
The trial allows participants to continue taking certain medications like immunosuppressants, corticosteroids, mTOR inhibitors, or calcineurin inhibitors, as long as the dose has been stable for at least 28 days before starting the trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.
What data supports the effectiveness of the drug Crovalimab for treating atypical hemolytic uremic syndrome?
Research on similar drugs like ravulizumab and eculizumab, which also target the complement system, shows they are effective in treating atypical hemolytic uremic syndrome by rapidly resolving symptoms and improving kidney function. This suggests that Crovalimab, which works in a similar way, may also be effective.12345
Research Team
CT
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Eligibility Criteria
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.Inclusion Criteria
I have been treated with eculizumab or ravulizumab.
I have shown improvement with a C5 inhibitor treatment.
For female participants of childbearing potential: an agreement to remain abstinent or use contraception
See 9 more
Exclusion Criteria
I have recently taken tranexamic acid.
I will start or have started PE/PI treatment within 8 weeks before my first crovalimab dose.
You have cryoglobulinemia when you are screened for the study, especially if you have recently been treated with a C5 inhibitor.
See 20 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive crovalimab for 24 weeks to evaluate efficacy and safety
24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Crovalimab (Monoclonal Antibodies)
Trial OverviewThe 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.
Participant Groups
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 Complement Component 5 (C5) inhibitor and \[3\] C5 Single Nucleotide Polymorphism (C5 inhibitor) Cohort - participants with documented C5 polymorphism.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Brigham and Womens HospitalBoston, MA
University of Cincinnati Medical CenterCincinnati, OH
University Hospitals Cleveland Medical CenterCleveland, OH
Univ of CA San FranciscoSan Francisco, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Trials
2482
Patients Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Chugai Pharmaceutical
Industry Sponsor
Trials
105
Patients Recruited
25,000+
Findings from Research
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Long-Term Efficacy and Safety of the Long-Acting Complement C5 Inhibitor Ravulizumab for the Treatment of Atypical Hemolytic Uremic Syndrome in Adults.Barbour, T., Scully, M., Ariceta, G., et al.[2022]
Eculizumab and ravulizumab are both effective and safe treatments for atypical hemolytic uremic syndrome (aHUS), but ravulizumab is preferred due to its lower financial burden and less frequent dosing, making it more convenient for patients and caregivers.
Genetic mutations in complement factors are linked to a higher risk of disease recurrence, suggesting that treatment should start promptly upon identifying these mutations to prevent complications.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Eculizumab Versus Ravulizumab for the Treatment of Atypical Hemolytic Uremic Syndrome: A Systematic Review.Shahid, K., Qayyum, S.[2023]
In a clinical trial involving 10 pediatric patients with atypical hemolytic uremic syndrome (aHUS), switching from eculizumab to ravulizumab resulted in stable kidney function and hematologic parameters over a 52-week period, with no patients requiring dialysis.
Ravulizumab was found to be safe, with common adverse events being upper respiratory infections and oropharyngeal pain, but no serious infections or deaths reported, indicating a favorable safety profile for this long-acting C5 inhibitor.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The long-acting C5 inhibitor, ravulizumab, is efficacious and safe in pediatric patients with atypical hemolytic uremic syndrome previously treated with eculizumab.Tanaka, K., Adams, B., Aris, AM., et al.[2022]
Atypical uremic hemolytic syndrome is a serious condition caused by excessive activation of the complement system, leading to symptoms like hemolytic anemia, low platelet counts, and acute kidney failure, with genetic mutations found in up to 60% of patients.
Early diagnosis and treatment with eculizumab can significantly improve patient outcomes by quickly disrupting the disease process, reducing the need for dialysis and enhancing kidney function.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Management of atypical uremic hemolytic syndrome in pregnant patient.Simón Polo, E., Hernández Laforet, J., Carretero de la Encarnación, B., et al.[2021]
Hemolytic uremic syndrome (HUS) is linked to mutations in complement regulatory proteins, which can lead to atypical HUS (aHUS), highlighting the importance of genetic testing for better patient outcomes.
Current treatments include plasma infusion/exchange, but emerging complement inhibitor therapies show promise for improving treatment efficacy and patient prognosis.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Complement regulatory genes and hemolytic uremic syndromes.Kavanagh, D., Richards, A., Atkinson, J.[2008]
References
Long-Term Efficacy and Safety of the Long-Acting Complement C5 Inhibitor Ravulizumab for the Treatment of Atypical Hemolytic Uremic Syndrome in Adults. [2022]
Eculizumab Versus Ravulizumab for the Treatment of Atypical Hemolytic Uremic Syndrome: A Systematic Review. [2023]
The long-acting C5 inhibitor, ravulizumab, is efficacious and safe in pediatric patients with atypical hemolytic uremic syndrome previously treated with eculizumab. [2022]
Management of atypical uremic hemolytic syndrome in pregnant patient. [2021]
Complement regulatory genes and hemolytic uremic syndromes. [2008]