Study Details
Testing the Study Drug Crovalimab in People with Atypical Hemolytic Uremic Syndrome
(IRB#: IRB_00161592)
This study will test a new treatment called Crovalimab to treat people with Atypical Hemolytic Uremic Syndrome (aHUS). aHUS is a rare disease that causes tiny blood clots to form in the small blood vessels of the body. This condition can lead to organ damage and failure in the body such as kidneys. The study wants to see if Crovalimab will help people with this disease and is safe. People in this study will be placed in one of three groups; people who have not been treated with Crovalimab, people who are changing their current treatment from Eculizumab or Ravulizumab to Crovalimab, or people who received Eculizumab or Ravulizumab in the past, the treatment stopped, and now a doctor decided to restart the treatment. The amount of Crovalimab a person receives depends upon the weight of the participant. Crovalimab is given as a liquid into the participants vein and given under the skin. Study participation may be up to 7 years and requires attending in-person at study clinics. Medical tests will be done during the study to track the health of participants.
- All genders
- All Ages
- Healthy Volunteers
- In Person
- Paid
Who can participate?
Gender: All genders
Age: All Ages
Volunteers: Healthy Volunteers
Location: In Person
Inclusion Criteria
- Participants ages 28 days to less than 18 years old at the beginning of the study
- Patients with prior kidney transplant is acceptable
- Participants of childbearing age are willing to use birth control
- Able to attend in person at a study clinic
Exclusion Criteria
- Positive Coombs test
- History of bone marrow or organ transplant other than kidney transplant
- Chronic dialysis 90 days before participation
- History of kidney disease other than aHUS
- History of reaction to any ingredient in Crovalimab
Will I be paid for my time?
Yes
IRB#: IRB_00161592
PI: Joseph Sherbotie
Department: PEDIATRICS
Approval Date: 2023-06-07 06:00:00
Specialties: Nephrology & Hypertension