Ravulizumab in Thrombotic Microangiopathy Associated With a Trigger
NCT ID: NCT04743804
Last Updated: 2024-10-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
16 participants
INTERVENTIONAL
2021-06-29
2022-12-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ravulizumab
Ravulizumab
Body weight-based doses of ravulizumab will be administered intravenously as loading dose regimen followed by maintenance dosing every 8 weeks.
Best Supportive Care
Participants will receive medications, therapies, and interventions per standard hospital treatment protocols (unless specifically prohibited by the protocol).
Placebo
Placebo
Matching placebo
Best Supportive Care
Participants will receive medications, therapies, and interventions per standard hospital treatment protocols (unless specifically prohibited by the protocol).
Interventions
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Ravulizumab
Body weight-based doses of ravulizumab will be administered intravenously as loading dose regimen followed by maintenance dosing every 8 weeks.
Placebo
Matching placebo
Best Supportive Care
Participants will receive medications, therapies, and interventions per standard hospital treatment protocols (unless specifically prohibited by the protocol).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Body weight ≥ 30 kilograms
3. Female participants of childbearing potential and male participants with female partners of childbearing potential must use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ravulizumab
4. TMA associated with a trigger (autoimmune disease, infection, solid organ transplant, drugs, and malignant hypertension)
5. Vaccinated against meningococcal infection (Neisseria meningitidis), within 3 years prior to, or at the time of, randomization. Participants who initiate study drug treatment less than 2 weeks after receiving a meningococcal vaccine must receive appropriate prophylactic antibiotics for at least 2 weeks after the vaccination. If participant cannot receive the meningococcal vaccine, then participant must be willing to receive antibiotic prophylaxis coverage against N. meningitidis during the entire Treatment Period and for 8 months following the final dose of study drug. Additional vaccination (Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae) may be considered based on individual patient condition.
Exclusion Criteria
2. Postpartum aHUS
3. Known chronic kidney disease
4. TMA due to hematopoietic stem cell transplantation ≤ 12 months of Screening
5. Primary and secondary glomerular diseases other than lupus
6. Diagnosis of primary antiphospholipid antibody syndrome
7. Shiga toxin-producing Escherichia coli infections including but not limited to Shiga toxin-related hemolytic uremic syndrome
8. Known familial or acquired 'a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13' (ADAMTS13) deficiency (activity \< 5%)
9. Positive direct Coombs test which in the judgement of the Investigator is indicative of a clinically significant immune-mediated hemolysis not due to TMA
10. Clinical diagnosis of disseminated intravascular coagulation (DIC) in the judgement of the Investigator
11. Presence of sepsis requiring vasopressors within 7 days prior to or during Screening
12. Presence of monoclonal gammopathy including but not limited to multiple myeloma
13. Known bone marrow insufficiency or failure evidenced by cytopenias
14. Unresolved N. meningitidis infection
15. History of malignancy within 5 years of Screening with the exception of nonmelanoma skin cancer or carcinoma in situ of the cervix that has been treated with no evidence of recurrence
16. Use of any complement inhibitors within the past 3 years
17. Respiratory failure requiring mechanical ventilation
18 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Research Site
Tucson, Arizona, United States
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Orange, California, United States
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Washington D.C., District of Columbia, United States
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Gainesville, Florida, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Rochester, Minnesota, United States
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New York, New York, United States
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Valhalla, New York, United States
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Winston-Salem, North Carolina, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Salt Lake City, Utah, United States
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Morgantown, West Virginia, United States
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Belgium, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Belo Horizonte, , Brazil
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Botucatu, , Brazil
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Campinas, , Brazil
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Fortaleza, , Brazil
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Porto Alegre, , Brazil
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Ribeirão Preto, , Brazil
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Salvador, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Kingston, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Bordeaux, , France
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Chambéry, , France
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Lille, , France
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Montpellier, , France
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Paris, , France
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Paris, , France
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Tours, , France
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Essen, , Germany
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Hanover, , Germany
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Bergamo, , Italy
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Roma, , Italy
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Bunkyō City, , Japan
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Iruma-Gun, , Japan
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Mitaka-shi, , Japan
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Miyazaki, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Osaka, , Japan
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Sapporo, , Japan
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Sendai, , Japan
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Shinjuku-ku, , Japan
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Amsterdam, , Netherlands
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Groningen, , Netherlands
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Maastricht, , Netherlands
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Nijmegen, , Netherlands
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Daegu, , South Korea
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Gwangju, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Granada, , Spain
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Las Palmas de Gran Canaria, , Spain
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Madrid, , Spain
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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New Taipei City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Bristol, , United Kingdom
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Carshalton, , United Kingdom
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Exeter, , United Kingdom
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Leicester, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Nottingham, , United Kingdom
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Oxford, , United Kingdom
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Salford, , United Kingdom
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Stevenage, , United Kingdom
Countries
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References
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Werion A, Storms P, Zizi Y, Beguin C, Bernards J, Cambier JF, Dahan K, Dierickx D, Godefroid N, Hilbert P, Lambert C, Levtchenko E, Meyskens T, Poire X, van den Heuvel L, Claes KJ, Morelle J; UCLouvain TMA/HUS Network and KU Leuven TMA/HUS Network. Epidemiology, Outcomes, and Complement Gene Variants in Secondary Thrombotic Microangiopathies. Clin J Am Soc Nephrol. 2023 Jul 1;18(7):881-891. doi: 10.2215/CJN.0000000000000182. Epub 2023 Apr 21.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-005328-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALXN1210-TMA-315
Identifier Type: -
Identifier Source: org_study_id
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