Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

This study aims to evaluate the efficacy and safety of crovalimab in adult and adolescent participants with aHUS.

Official Title

A Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Adult and Adolescent Patients With Atypical Hemolytic Uremic Syndrome (aHUS)

Keywords

Atypical Hemolytic Uremic Syndrome Azotemia Hemolytic-Uremic Syndrome Syndrome Hemolysis Crovalimab

Eligibility

You can join if…

Open to people ages 12 years and up

  • Body weight >= 40 kg at screening.
  • Vaccination against Neisseria meningitidis serotypes A, C, W, and Y; vaccination against serotypes B, according to national vaccination recommendations.
  • Vaccination against Haemophilus influenzae type B and Streptococcus pneumoniae, according to national vaccination recommendations.
  • For patients continuing to receive other therapies concomitantly with crovalimab (e.g., immunosuppressants, corticosteroids, mTORi, or calcineurin inhibitors): stable dose for >=28 days prior to screening and up to the first crovalimab administration.
  • For female participants of childbearing potential: an agreement to remain abstinent or use contraception.
  • Female patients of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of crovalimab.
  • Participants with a prior kidney transplant are eligible if they have a known history of complement-mediated aHUS prior to the kidney transplant.
  • Onset of initial TMA presentation within 28 days prior to the first dose of crovalimab (for Naive Cohort only).
  • Documented treatment with either eculizumab or ravulizumab (for Switch Cohort only).
  • Clinical evidence of response to a C5 inhibitor (for Switch Cohort only).
  • Known C5 polymorphism (for C5 SNP Cohort only).
  • Poorly controlled TMA following treatment with another C5 inhibitor (for C5 SNP Cohort only).

You CAN'T join if...

  • TMA associated with non-aHUS related renal disease.
  • Positive direct Coombs test.
  • Chronic dialysis and/or end stage renal disease.
  • Identified drug exposure-related TMA.
  • Presence or history of a condition that could trigger TMA, such as malignancy, bone marrow or organ transplant (other than kidney transplant) or autoimmune disease.
  • History of a kidney disease, other than aHUS.
  • History of Neisseria meningitidis infection within 6 months of study enrollment.
  • Known or suspected immune deficiency (e.g., history of frequent recurrent infections).
  • Positive HIV test.
  • Active systemic bacterial, viral, or fungal infection within 14 days before first crovalimab administration
  • Presence of fever (>= 38oC) within 7 days before the first crovalimab administration
  • Multi-system organ dysfunction or failure.
  • Recent IVIg treatment.
  • Pregnant or breastfeeding or intending to become pregnant.
  • Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within five half lives of that investigational product, whichever is greater.
  • Recent use of tranexamic acid.
  • Current or previous treatment with a complement inhibitor (for Naive Cohort only).
  • First initiation of plasma exchange/plasma infusions (PE/PI) should not be more than 28 days prior to first crovalimab administration (for Naive Cohort only).
  • PE/PI should not be administered within 6 hours of first crovalimab administration (for Naive Cohort only).
  • Receiving PE/PI within 8 weeks of the first crovalimab administration (Switch Cohort only)
  • Positive for active Hepatitis B and C infection (HBV/HCV) (for Switch Cohort and C5 SNP Cohort participants who recently received C5 inhibitor treatment).
  • Cryoglobulinemia at screening (for Switch Cohort and C5 SNP Cohort participants who recently received C5 inhibitor treatment).
  • Documented condition leading to non-aHUS TMA: Thrombotic Thrombocytopenic Purpura (TTP), Shiga Toxin producing Escherichia Coli (STEC)-TMA, Pneumococcal HUS, TMA secondary to cobalamin C defect and TMA related to Diacylglycerol kinase ε (DGKE) nephropathy.

Locations

  • University of California Irvine Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868 United States
  • Vancouver General Hospital accepting new patients
    Vancouver British Columbia V5Z 1L8 Canada

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
Links
Sign up for this study
ID
NCT04861259
Phase
Phase 3 Hemolytic-Uremic Syndrome Research Study
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated