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Ravulizumab in Thrombotic Microangiopathy Associated With a Trigger | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Ravulizumab in Thrombotic Microangiopathy Associated With a Trigger

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

NCT04743804•Alexion Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18 years of age or older
•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

•1. Any known gene mutation that causes atypical hemolytic uremic syndrome (aHUS)
•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
+7 more criteria

Locations (97)

Research Site

Tucson, Arizona, United States

Research Site

Orange, California, United States

Research Site

Washington D.C., District of Columbia, United States

Research Site

Gainesville, Florida, United States

Research Site

Lexington, Kentucky, United States

Research Site

Louisville, Kentucky, United States

Research Site

Boston, Massachusetts, United States

Research Site

Boston, Massachusetts, United States

Research Site

Boston, Massachusetts, United States

Research Site

Rochester, Minnesota, United States

Key Dates

Start Date

June 29, 2021

Primary Completion Date

December 22, 2022

Completion Date

December 22, 2022

Last Updated

October 1, 2024

Enrollment

ACTUAL participants

Conditions

Thrombotic Microangiopathy

Interventions

Ravulizumab

BIOLOGICAL

Placebo

OTHER

Best Supportive Care

OTHER

Thrombotic Microangiopathy (TMA) Associated With Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) In Adult Patients

NCT07059026

Thrombotic Microangiopathy

View study

RECRUITINGPHASE4

Thymoglobulin® Pharmacokinetics in Patients Undergoing Hematopoietic Stem Cell Transplantation

NCT05743400

Hematopoietic Stem Cell Transplantation-Associated Thrombotic Microangiopathy

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RECRUITING

National Registry of Rare Kidney Diseases

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Ravulizumab in Thrombotic Microangiopathy Associated With a Trigger

Inclusion Criteria

Exclusion Criteria

Thrombotic Microangiopathy (TMA) Associated With Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) In Adult Patients

Thymoglobulin® Pharmacokinetics in Patients Undergoing Hematopoietic Stem Cell Transplantation

National Registry of Rare Kidney Diseases

Single Patient Expanded Access Treatment Plan For The Investigational Product Narsoplimab

A Study of Pegcetacoplan for Patients With Transplant-associated Thrombotic Microangiopathy After Hematopoietic Stem Cell Transplantation

International Registry and Biorepository for TMA(Thrombotic Microangiopathy)