Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novo Nordisk A/S
Study ID
NCT03926117
Phase
PHASE2
Status
Completed

Conditions

  • Chronic Kidney Diseases
  • Inflammation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ziltivekimab — BIOLOGICAL
    human IgG1k anti-human IL-6 monoclonal antibody

Study Details

Patients with chronic kidney disease, who have evidence of systemic inflammation with increased cardiovascular risk, will be enrolled into this trial. The purpose of this trial is to determine a dose to select for a potential cardiovascular outcome trial with Ziltivekimab. Doses to be tested will be 7.5 mg, 15 mg and 30 mg subcutaneous monthly compared to placebo for six months.

Key Dates

Start date
Jun 3, 2019
Status verified
Dec 2025
Primary completion
Jun 26, 2020
Completion
Jun 26, 2020

Study Design

Enrollment
264 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Matching placebo
  • Experimental: Ziltivekimab 7.5 mg
  • Experimental: Ziltivekimab 15 mg
  • Experimental: Ziltivekimab 30 mg

Primary Outcome Measure

Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) Levels [ Time Frame: Baseline (average of the hs-CRP value prior to randomization and day 1), week 13 ]

Locations (49)

FacilityCityStateZIPSite coordinators
Central Alabama ResearchBirminghamAlabama35205-
Aventiv ResearchMesaArizona85210-
Arizona Kidney Disease and Hypertension CenterPhoenixArizona85016-
Elite Clinical StudiesPhoenixArizona85018-
North America Research InstituteLynwoodCalifornia90262-
Apex Research of RiversideRiversideCalifornia92505-
North America Research InstituteRiversideCalifornia92503-
North America Research InstituteSan DimasCalifornia91773-
Western Nephrology and Metabolic Bone Disease, PCArvadaColorado80002-
AMPM Research ClinicMiamiFlorida33169-
Ocala Cardiovascular ResearchOcalaFlorida34474-
Florida Premier Research Institue, LLCWinter ParkFlorida32789-
Southeastern Clinical Research Institute, LLCAugustaGeorgia30901-
Columbus Regional Research InstituteColumbusGeorgia31904-
Investigator Research by Design, LLCChicagoIllinois60643-
University of IowaIowa CityIowa52242-
Clinical Trials of America, LLC - West MonroeMonroeLouisiana71201-
Capital NephrologyGreenbeltMaryland20770-
Onyx Clinical ResearchCaroMichigan48723-
Henry Ford Health SystemDetroitMichigan48202-
St. Clair Nephrology ResearchRosevilleMichigan48066-
Nephrology Research of MichiganSaint Clair ShoresMichigan48081-
DaVita Clinical ResearchMinneapolisMinnesota55404-
Julia and Israel Waldbaum Dialysis CenterGreat NeckNew York11021-
Northport VAMCNorthportNew York11768-
DaVita Clinical ResearchThe BronxNew York10461-
Mountain Kidney and Hypertension AssociatesAshevilleNorth Carolina28801-
Metrolina Nephrology AssociatesCharlotteNorth Carolina28277-
Metrolina Nephrology Associates, PACharlotteNorth Carolina28207-
Southeastern Nephrology - WhitevilleWhitevilleNorth Carolina28472-
Southeastern Nephrology Associates - WilmingtonWilmingtonNorth Carolina28401-
Summit Research Group, LLCStowOhio44224-
Northeast Clinical Research CenterAllentownPennsylvania18104-
Rhode Island HospitalProvidenceRhode Island02903-
Piedmont Research Partners, LLCFort MillSouth Carolina29707-
Mountain View CLinical Research - GreerGreerSouth Carolina29651-
Knoxville Kidney Center, PLLCKnoxvilleTennessee37923-
Nephrology Associates, PCNashvilleTennessee37205-
Renal Disease Research InstituteDallasTexas75246-
Biopharma Informatick Inc. Research CenterHoustonTexas77043-
Juno Research, LLC - NorthwestHoustonTexas77070-
Vilo Research Group, IncHoustonTexas77017-
North Hills Medical Research, IncNorth Richland HillsTexas76180-
Clinical Advancement Center, PLLCSan AntonioTexas78212-
San Antonio Kidney Disease Center Physicians Group, PLLCSan AntonioTexas78229-
University of VermontBurlingtonVermont05401-
Southside Urology and NephrologyDanvilleVirginia25241-
Manassas Clinical Research CenterManassasVirginia20110-
Clinical Investigation Specialist, IncKenoshaWisconsin53142-

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