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

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
Amgen
Study ID
NCT06072482
Phase
PHASE4
Status
Recruiting
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Conditions

  • Antineutrophil Cytoplasmic Antibody-associated Vasculitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Avacopan — DRUG
    Administered orally.
  • Placebo — DRUG
    Administered orally.
  • Standard of Care — DRUG
    All participants will receive SoC background immunosuppressive therapy for induction and maintenance, at the discretion of the Investigator and as supported by current guidelines, product labels and local practices and informed by the individual participant's clinical condition, preferences, and values.

Study Details

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).

Key Dates

Start date
Feb 7, 2024
Status verified
May 2026
Primary completion
Dec 31, 2036
Completion
Dec 31, 2036

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A: Avacopan + Standard of Care (SoC)
    Avacopan 30 mg twice daily for 5 years + SoC background immunosuppressive therapy.
  • Experimental: Group B: Avacopan/Placebo + SoC
    Avacopan 30 mg twice daily for 1 year, followed by placebo twice daily for 4 years + SoC background immunosuppressive therapy.
  • Placebo Comparator: Group C: Placebo + SoC
    Placebo twice daily for 5 years + SoC background immunosuppressive therapy.

Primary Outcome Measure

Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to Month 60 ]

Central Contacts

Locations (60)

FacilityCityStateZIPSite coordinators
Orthopedic Physicians AlaskaAnchorageAlaska99508-
Scottsdale Healthcare at Shea - HonorHealthScottsdaleArizona85258-
Southwest Kidney InstituteSurpriseArizona85374-
Unity HealthSearcyArkansas72143-
Medvin Clinical ResearchCovinaCalifornia91722-
Palo Alto Medical Foundation FremontFremontCalifornia94538-
The Nephrology GroupFresnoCalifornia93720-
Providence Medical FoundationFullertonCalifornia92835-
Medvin Clinical ResearchMenifeeCalifornia92586-
University of California San Francisco- Zuckerburg San Francisco GeneralSan FranciscoCalifornia94110-
Harbor University of California at Los Angeles Medical CenterTorranceCalifornia90502-
University of ColoradoAuroraColorado80045-
Florida Kidney PhysiciansBoca RatonFlorida33431-
Malcom Randall Veterans Affairs Medical CenterGainesvilleFlorida32608-
Mayo ClinicJacksonvilleFlorida32224-
ClinTrial Research Oakwater, LlcOrlandoFlorida32806-
University of South FloridaTampaFlorida33606-
Emory UniversityAtlantaGeorgia30322-
Lake Cumberland RheumatologyNew AlbanyIndiana47150-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
Dunes Clinical Research LLCSioux CityIowa51104-
University of KentuckyLexingtonKentucky40536-
Johns Hopkins Bayview Medical CenterBaltimoreMaryland21224-
Brigham and Womens HospitalBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-
Henry Ford Health SystemDetroitMichigan48202-
Kidney Michigan InstituteSaginawMichigan49804-
Clinical Research Institute of MichiganSaint Clair ShoresMichigan48081-
Revive Research InstituteSterling HeightsMichigan48313-
University of MinnesotaMinneapolisMinnesota55414-
Mayo ClinicRochesterMinnesota55905-
Renown RheumatologyRenoNevada89502-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03766-
Renal Medicine AssociatesAlbuquerqueNew Mexico87109-
New York Nephrology Vasculitis and Glomerular CenterAlbanyNew York12209-
Northwell HealthGreat NeckNew York11021-
Hospital For Special SurgeryNew YorkNew York10021-
Carolina Kidney AssociatesGreensboroNorth Carolina27405-
East Carolina University Brody Outpatient CenterGreenvilleNorth Carolina27834-
Brookview Hills Research Associates LlcWinston-SalemNorth Carolina27103-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
The Ohio State UniversityColumbusOhio43201-
Stat ResearchMiamisburgOhio45342-
Hightower ClinicalOklahoma CityOklahoma73114-
Oregon Health and Science UniversityPortlandOregon97239-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Allegheny Health Network Cancer Institute at Mellon PavilionPittsburghPennsylvania15224-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
Nephrology Associates IncEast ProvidenceRhode Island02914-
Medical University of South CarolinaCharlestonSouth Carolina29425-
West Tennessee Research InstituteJacksonTennessee38305-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Vital RheumatologyAustinTexas78727-
Renal Disease Research Institute - Landry OfficeDallasTexas75204-
Epic Medical Research - Red OakRed OakTexas75154-
Scott and White Memorial HospitalTempleTexas76502-
Nephrology Associates of Northern Virginia IncFairfaxVirginia22033-
Virginia Mason Medical CenterSeattleWashington98101-
Rheumatology and Pulmonary ClinicBeckleyWest Virginia25801-
Medical College of WisconsinMilwaukeeWisconsin53226-

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By research site
Orthopedic Physicians Alaska· Anchorage, AKScottsdale Healthcare at Shea - HonorHealth· Scottsdale, AZSouthwest Kidney Institute· Surprise, AZUnity Health· Searcy, ARMedvin Clinical Research· Covina, CAPalo Alto Medical Foundation Fremont· Fremont, CA

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