RECRUITING

A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis

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Conditions

Antineutrophil Cytoplasmic Antibody-associated VasculitisAvacopanANCA-associated VasculitisAAV

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this study is to evaluate the long-term safety of avacopan in participants with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).

Official Title

A Randomized, Double-blind, Placebo-controlled Phase 4 Clinical Trial to Evaluate the Long-term Safety and Efficacy of Avacopan in Subjects With Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis

Quick Facts

Study Start:2024-02-07
Study Completion:2031-10-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06072482

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants has provided informed consent before initiation of any study-specific activities/procedures.
  2. * Newly diagnosed or relapse of granulomatosis with polyangiitis or microscopic polyangiitis, consistent with Chapel-Hill Consensus Conference definitions (Jennette et al, 2013), where treatment with cyclophosphamide or rituximab is needed.
  3. * Age \>/= 18 years (or \>/= legal age within the country if it is older than 18 years).
  4. * Positive test for anti-positive antiproteinase 3 or antimyeloperoxidase (current or historic) antibodies.
  5. * At least 1 Birmingham Vasculitis Activity Score (BVAS) major item, at least 3 BVAS nonmajor items, or at least the 2 renal items of proteinuria and hematuria.
  6. * eGFR 15 mL/min/1.73 m\^2 (using Chronic Kidney Disease Epidemiology Collaboration equations).
  7. * Alveolar hemorrhage requiring invasive pulmonary ventilation support anticipated to last beyond the screening period of the study.
  8. * Any other known multisystem autoimmune disease including eosinophilic granulomatosis with polyangiitis (Churg-Strauss), systemic lupus erythematosus, immunoglobulin A vasculitis (Henoch-Schönlein), rheumatoid vasculitis, Sjogren's syndrome, anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis.
  9. * Any medical condition requiring or expected to require continued use of immunosuppressive therapies, including corticosteroids that may cause confoundment with study assessments and study conclusions.
  10. * Received dialysis or plasma exchange within 12 weeks before signing of the informed consent.
  11. * Have had a kidney transplant.
  12. * Malignancy except nonmelanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years before signing the informed consent.
  13. * Acute or chronic, active hepatitis B virus or hepatitis C virus, or human immunodeficiency virus infection during screening.
  14. * Positive test for active or latent tuberculosis during screening.
  15. * White blood cell count \< 3500/µL, neutrophil count \< 1500/µL, or lymphocyte count \< 500/µl.
  16. * Evidence of clinically significant hepatic disease including prior diagnosis of cirrhosis.
  17. * aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase \>2.0 times the upper limit of normal (ULN).
  18. * Total bilirubin \> 1.5 times the ULN. A participant with documented Gilbert's syndrome with total bilirubin \< 2 x ULN may be eligible.
  19. * Active infection and/or infection requiring oral or intravenous (IV) antimicrobials within 4 weeks before signing of the informed consent.
  20. * History of any clinically significant cardiovascular disease, such as symptomatic congestive heart failure, unstable angina, myocardial infarction or stroke, within 12 weeks before signing of the informed consent.
  21. * Received cyclophosphamide (CYC) within 12 weeks before signing the informed consent; if on azathioprine, mycophenolate, or methotrexate at the time of screening, these drugs must be withdrawn before receiving the CYC or rituximab (RTX).
  22. * Have been taking an oral daily dose of a glucocorticoid of more than 10 mg prednisone equivalent for more than 6 weeks continuously before signing of the informed consent.
  23. * Received RTX or other B-cell depleting therapies within 52 weeks before signing of the informed consent or within 26 weeks before signing of the informed consent provided CD19 count \> 0.01x10\^9/L, or received any of the following within 12 weeks before signing the informed consent:
  24. * antitumor necrosis factor treatment
  25. * abatacept
  26. * alemtuzumab
  27. * IV immunoglobulin
  28. * belimumab
  29. * tocilizumab.
  30. * Taking a strong or moderate inducer of the cytochrome P450 3A4 (CYP3A4) enzyme unless the strong or moderate CYP3A4 inducer can be changed to an alternative medicine at least 1 week before Day 1.
  31. * Received an investigational drug within 30 days or within 5 half-lives (whichever is longer) before signing of the informed consent.
  32. * Previously received avacopan without clinical benefit per the Investigator's opinion or received avacopan within 60 days before signing of the informed consent.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Amgen Call Center
CONTACT
866-572-6436
medinfo@amgen.com

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

Orthopedic Physicians Alaska
Anchorage, Alaska, 99508
United States
Southwest Kidney Institute
Surprise, Arizona, 85374
United States
Medvin Clinical Research
Covina, California, 91722
United States
Palo Alto Medical Foundation Fremont
Fremont, California, 94538
United States
The Nephrology Group
Fresno, California, 93720
United States
Providence Medical Foundation
Fullerton, California, 92835
United States
Medvin Clinical Research
Menifee, California, 92586
United States
Harbor University of California at Los Angeles Medical Center
Torrance, California, 90502
United States
Florida Kidney Physicians
Boca Raton, Florida, 33431
United States
Lake Cumberland Rheumatology
New Albany, Indiana, 47150
United States
University of Kentucky
Lexington, Kentucky, 40536
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Brigham and Womens Hospital
Boston, Massachusetts, 02115
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
New York Nephrology Vasculitis and Glomerular Center
Albany, New York, 12209
United States
Northwell Health
Great Neck, New York, 11021
United States
Hospital For Special Surgery
New York, New York, 10021
United States
East Carolina University Brody Outpatient Center
Greenville, North Carolina, 27834
United States
Brookview Hills Research Associates Llc
Winston-Salem, North Carolina, 27103
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
The Ohio State University
Columbus, Ohio, 43201
United States
Stat Research
Miamisburg, Ohio, 45342
United States
Hightower Clinical
Oklahoma City, Oklahoma, 73114
United States
Allegheny Health Network Cancer Institute at Mellon Pavilion
Pittsburgh, Pennsylvania, 15224
United States
Nephrology Associates Inc
East Providence, Rhode Island, 02914
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
West Tennessee Research Institute, llc
Jackson, Tennessee, 38305
United States
Renal Disease Research Institute - Landry Office
Dallas, Texas, 75204
United States
Nephrology Associates of Northern Virginia Inc
Fairfax, Virginia, 22033
United States
Virginia Mason Medical Center
Seattle, Washington, 98101
United States
Rheumatology and Pulmonary Clinic
Beckley, West Virginia, 25801
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-07
Study Completion Date2031-10-04

Study Record Updates

Study Start Date2024-02-07
Study Completion Date2031-10-04

Terms related to this study

Keywords Provided by Researchers

  • Avacopan
  • ANCA-associated Vasculitis
  • AAV

Additional Relevant MeSH Terms

  • Antineutrophil Cytoplasmic Antibody-associated Vasculitis