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.
  • For participants receiving other therapies (e.g., immunosuppressants, corticosteroids, mTORi, or calcineurin inhibitors: stable dose for 28 days.
  • For female participants of childbearing potential: an agreement to remain abstinent or use contraception.
  • Participants with a prior kidney transplant are eligible if they have a known history of complement-mediated aHUS prior to the kidney transplant.
  • Evidence of TMA (for Naive Cohort only).
  • Onset of TMA =<28 days prior to first crovalimab administration (for Naive Cohort only).
  • Documented treatment with a C5 inhibitor (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, 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.
  • Known or suspected immune deficiency (e.g., history of frequent recurrent infections).
  • Positive HIV test.
  • 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 Naïve 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
    Orange California 92868 United States
  • Univ of CA San Francisco
    San Francisco California 94143-0435 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT04861259
Phase
Phase 3
Study Type
Interventional
Last Updated