What side effects are associated with this type of intervention?

Common treatments for Atypical Hemolytic Uremic Syndrome (aHUS) that target the complement system, such as monoclonal antibodies like eculizumab and potentially crovalimab, often have side effects including increased risk of infections (particularly meningococcal infections), infusion-related reactions, hypertension, and gastrointestinal symptoms like nausea and diarrhea. Patients may also experience headaches and fatigue. It is crucial to monitor for these side effects and manage them promptly under medical supervision.

What prior FDA approvals exist?

The FDA has approved eculizumab and ravulizumab for the treatment of Atypical Hemolytic Uremic Syndrome (aHUS). Both drugs are monoclonal antibodies that target the complement protein C5, inhibiting the formation of the membrane attack complex and reducing complement-mediated damage. These treatments help prevent the progression of aHUS by protecting blood vessels from further damage.

What other types of research exist?

Promising novel alternatives to Crovalimab for aHUS patients in 2024 may include other monoclonal antibodies targeting the complement system, such as Eculizumab, which is already used for aHUS. Additionally, emerging therapies targeting different components of the complement pathway or novel small molecule inhibitors could be considered. Consulting with a healthcare provider for the latest clinical trial data and approved treatments is recommended.

← Back to Search

Monoclonal Antibodies

Crovalimab for Atypical Hemolytic Uremic Syndrome (COMMUTE-p 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

Body weight >= 5 kg at screening

Vaccination against Neisseria meningitis serotypes A, C, W, and Y; vaccination against serotype B, according to national vaccination recommendations

Must not have

Multi-system organ dysfunction or failure

Recent intravenous immunoglobulin (IVIg) treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing crovalimab, a medication that helps control the immune system, in children with a rare disease called aHUS. The goal is to see if it is safe and effective for these patients. Crovalimab works by calming down an overactive part of the immune system to prevent damage to the body. Another similar medication, eculizumab, has been used effectively to treat aHUS by inhibiting the complement system.

Who is the study for?

This trial is for children with atypical Hemolytic Uremic Syndrome (aHUS) who weigh at least 5 kg and are vaccinated against certain infections. They must not have HIV, active hepatitis B/C, or other conditions that could cause similar symptoms. Those with a kidney transplant due to aHUS can join; females of childbearing age should use contraception.

What is being tested?

The study tests Crovalimab's effectiveness and safety in treating pediatric aHUS patients. It includes those new to treatment, switching from another C5 inhibitor therapy, or having specific genetic variations affecting their response to such treatments.

What are the potential side effects?

While the side effects of Crovalimab aren't detailed here, it's common for drugs like this to potentially cause infusion reactions, increase infection risk, and possibly lead to abnormal blood test results reflecting organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My body weight is at least 5 kg.

Select...

I am vaccinated against meningitis as per my country's guidelines.

Select...

My TMA is not well-managed after treatment with a C5 inhibitor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My organs are failing.

Select...

I have recently received IVIg treatment.

Select...

I have had kidney disease, but not aHUS.

Select...

I have not had a serious infection in the last 14 days.

Select...

I have a condition caused by a reaction to a medication.

Select...

I have or had a condition like cancer, transplant, or autoimmune disease that could cause TMA.

Select...

I often get infections, suggesting I might have a weak immune system.

Select...

My TMA is not caused by aHUS but by another condition like TTP or E. coli.

Select...

My kidney disease is not caused by atypical HUS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

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.

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 \[3\] Pretreated Cohort (includes C5 SNP (Single Nucleotide Polymorphism) participants) - participants who received treatment with another C5 inhibitor and subsequently discontinued it.

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Atypical Hemolytic Uremic Syndrome (aHUS) is often driven by uncontrolled activation of the complement system, leading to cell damage and inflammation. Treatments like Crovalimab, a monoclonal antibody, target specific proteins in the complement pathway to inhibit their activity. By preventing the formation of the membrane attack complex, these treatments reduce cell lysis and inflammation, which is crucial for preventing kidney damage and other systemic complications in aHUS patients.