Trial record 2 of 465 for:
Microangiopathy
Ravulizumab in Thrombotic Microangiopathy Associated With a Trigger
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04743804 |
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Recruitment Status :
Recruiting
First Posted : February 8, 2021
Last Update Posted : May 10, 2022
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Sponsor:
Alexion Pharmaceuticals
Information provided by (Responsible Party):
Alexion Pharmaceuticals
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Brief Summary:
This study will investigate the efficacy and safety of ravulizumab compared to placebo in adult participants with thrombotic microangiopathy (TMA) associated with a trigger. Participants will be randomized to receive either ravulizumab plus best supportive care or placebo plus best supportive care. The treatment period is 26 weeks followed by a 26-week off-treatment follow-up period.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Thrombotic Microangiopathy | Biological: Ravulizumab Other: Placebo Other: Best Supportive Care | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants Who Have Thrombotic Microangiopathy Associated With a Trigger |
| Actual Study Start Date : | July 1, 2021 |
| Estimated Primary Completion Date : | January 31, 2024 |
| Estimated Study Completion Date : | June 30, 2024 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Ravulizumab
| Arm | Intervention/treatment |
|---|---|
| Experimental: Ravulizumab |
Biological: Ravulizumab
Body weight-based doses of ravulizumab will be administered intravenously as loading dose regimen followed by maintenance dosing every 8 weeks.
Other Names:
Other: Best Supportive Care Participants will receive medications, therapies, and interventions per standard hospital treatment protocols (unless specifically prohibited by the protocol). |
| Placebo Comparator: Placebo |
Other: Placebo
Matching placebo Other: Best Supportive Care Participants will receive medications, therapies, and interventions per standard hospital treatment protocols (unless specifically prohibited by the protocol). |
Primary Outcome Measures :
- Complete TMA Response [ Time Frame: 26 weeks (treatment period) ]
Secondary Outcome Measures :
- Time to Complete TMA Response [ Time Frame: 26 weeks (treatment period) ]
- Hematologic Response [ Time Frame: 26 weeks (treatment period) and through study completion, an average of 1 year ]
- Renal Response [ Time Frame: Through study completion, an average of 1 year ]
- On Dialysis [ Time Frame: Proportion of participants on dialysis at Week 26 ]
- Change in Kidney Function as measured by estimated glomerular filtration rate (eGFR) in mL/min/1.73m^2 [ Time Frame: 26 weeks (treatment period) and through study completion, an average of 1 year ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 years of age or older
- Body weight ≥ 30 kilograms
- 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
- TMA associated with a trigger (autoimmune disease, infection, solid organ transplant, drugs, and malignant hypertension)
- 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:
- Any known gene mutation that causes atypical hemolytic uremic syndrome (aHUS)
- Postpartum aHUS
- Known chronic kidney disease
- TMA due to hematopoietic stem cell transplantation ≤ 12 months of Screening
- Primary and secondary glomerular diseases other than lupus
- Diagnosis of primary antiphospholipid antibody syndrome
- Shiga toxin-producing Escherichia coli infections including but not limited to Shiga toxin-related hemolytic uremic syndrome
- Known familial or acquired 'a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13' (ADAMTS13) deficiency (activity < 5%)
- Positive direct Coombs test which in the judgement of the Investigator is indicative of a clinically significant immune-mediated hemolysis not due to TMA
- Clinical diagnosis of disseminated intravascular coagulation (DIC) in the judgement of the Investigator
- Presence of sepsis requiring vasopressors within 7 days prior to or during Screening
- Presence of monoclonal gammopathy including but not limited to multiple myeloma
- Known bone marrow insufficiency or failure evidenced by cytopenias
- Unresolved N. meningitidis infection
- 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
- Use of any complement inhibitors within the past 3 years
- Respiratory failure requiring mechanical ventilation
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04743804
Contacts
| Contact: Alexion Pharmaceuticals Inc. | 855-752-2356 | clinicaltrials@alexion.com |
Locations
Show 49 study locations
Sponsors and Collaborators
Alexion Pharmaceuticals
| Responsible Party: | Alexion Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT04743804 |
| Other Study ID Numbers: |
ALXN1210-TMA-315 |
| First Posted: | February 8, 2021 Key Record Dates |
| Last Update Posted: | May 10, 2022 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Alexion Pharmaceuticals:
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Complement Trigger Secondary thrombotic microangiopathy Acute kidney injury |
Additional relevant MeSH terms:
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Thrombotic Microangiopathies Vascular Diseases Cardiovascular Diseases Thrombocytopenia Blood Platelet Disorders Hematologic Diseases |
Ravulizumab Complement Inactivating Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |