An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Biogen
Study ID
NCT03749447
Phase
PHASE3
Status
Terminated

Conditions

  • Alport Syndrome
  • Autosomal Dominant Polycystic Kidney
  • Chronic Kidney Diseases

Eligibility Criteria

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

Interventions

  • Bardoxolone methyl — DRUG
    Bardoxolone methyl capsules

Study Details

This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with chronic kidney disease (CKD) who previously participated in one of the qualifying clinical studies with bardoxolone methyl. Patients will remain in the study until bardoxolone methyl is available through commercial channels or until patient withdrawal, whichever is sooner.

Key Dates

First listed
Nov 21, 2018
Start date
Mar 8, 2019
Status verified
May 2025
Primary completion
Aug 23, 2023
Completion
Aug 23, 2023

Study Design

Enrollment
270 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bardoxolone methyl
    Adult participants received bardoxolone methyl capsules, once daily (QD) at a starting dose of 5 milligrams (mg), followed by dose- escalation to 10 mg at Week 2 (Day 14 ± 3), and to 20 mg at Week 4 (Day 28 ± 3). Based on the eligibility UACR \>300 milligrams per gram (mg/g), the dose was increased to 30 mg starting from Week 6 (Day 42 ± 3) until the end of the study. Participants under 18 years of age received bardoxolone methyl capsules at a starting dose of 5 mg every other day during the first week and QD during the second week of the study, followed by dose-escalation to 10 mg at Week 2 and to 20 mg at Week 4. Based on the eligibility UACR \>300 mg/g, the dose was increased to 30 mg starting from Week 6 until the end of the study.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From the first dose of the study drug (baseline) up to the end of the study follow-up (up to 4.2 years) ]

Locations (61)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Apogee Clinical ResearchHuntsvilleAlabama35805-
Arizona Kidney Disease and Hypertension Research Services, PLLCGlendaleArizona85306-
Centricity Research Phoenix MultispecialtyMesaArizona85206-
California Institute Renal ResearchLa MesaCalifornia91942-
Academic Medical Research InstituteLos AngelesCalifornia90022-
David Geffen School of Medicine at UCLALos AngelesCalifornia90095-
Apex Research of RiversideRiversideCalifornia92505-
Rady Children's Hospital - San DiegoSan DiegoCalifornia92123-
University of California San Francisco - Children's Renal CenterSan FranciscoCalifornia94143-
University of California, San FranciscoSan FranciscoCalifornia94143-
Western NephrologyArvadaColorado80002-
University of Colorado Anschutz Medical CenterAuroraColorado80045-
Colorado Kidney Care, PCDenverColorado80230-
South Florida Research InstituteLauderdale LakesFlorida33313-
Innovation Medical Research, Inc.Palmetto BayFlorida33157-
USF Health South Tampa CenterTampaFlorida33606-
Florida Premier Research Institute, LLCWinter ParkFlorida32789-
Emory University School of MedicineAtlantaGeorgia30322-
Boise Kidney & Hypertension, PLLCCaldwellIdaho83605-
Boise Kidney & Hypertension, PLLCMeridianIdaho83642-
Northwestern UniversityChicagoIllinois60611-
Nephrology Research NorthShore University Health SystemEvanstonIllinois60201-
University of Kansas Medical CenterKansas CityKansas66224-
Renal Associates of Baton RougeBaton RougeLouisiana70808-
Northwest Louisiana NephrologyShreveportLouisiana71101-
The Johns Hopkins UniversityBaltimoreMaryland21287-
Tufts Medical CenterBostonMassachusetts02111-
Tufts Medical Center - Division of NephrologyBostonMassachusetts02110-
University of MichiganAnn ArborMichigan48109-
Nephrology Center, PCKalamazooMichigan49007-
Mayo ClinicRochesterMinnesota55905-
Children's Mercy Hospital and ClinicsKansas CityMissouri64108-
Clinical Research Consultants, LLCKansas CityMissouri64111-
Washington University School of MedicineSt LouisMissouri63110-
KSOSNLas VegasNevada89128-
Hackensack University Medical CenterHackensackNew Jersey07601-
Columbia University Medical CenterNew YorkNew York10032-
Mountain Kidney & Hypertension AssociatesAshevilleNorth Carolina28801-
North Carolina NephrologyCaryNorth Carolina27511-
Metrolina Nephrology AssociatesCharlotteNorth Carolina28208-
Duke University Medical CenterDurhamNorth Carolina27701-
Metrolina Nephrology AssociatesGastoniaNorth Carolina28054-
Cleveland ClinicClevelandOhio44195-
Remington-Davis Clinical ResearchColumbusOhio43215-
Oregon Health and Science UniversityPortlandOregon97239-
Northeast Clinical Research CenterBethlehemPennsylvania18017-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
UPMC Children's Hospital of PittsburghPittsburghPennsylvania15224-
Columbia Nephrology Associates, PAColumbiaSouth Carolina29203-
South Carolina Nephrology & Hypertension Center, IncOrangeburgSouth Carolina29118-
Arlington NephrologyArlingtonTexas76015-
Research Management, Inc.AustinTexas78751-
Renal Disease Research InstituteDallasTexas75204-
DaVita Med CenterHoustonTexas77004-
Southwest Houston ResearchHoustonTexas77099-
Clinical Advancement CenterSan AntonioTexas78215-
University of Vermont Medical CenterBurlingtonVermont05401-
Nephrology Associates of Northern Virginia, Inc.FairfaxVirginia22033-
Medical College of WisconsinMilwaukeeWisconsin53226-
Milwaukee Nephrologists, SCWauwatosaWisconsin53226-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALApogee Clinical Research· Huntsville, ALArizona Kidney Disease and Hypertension Research Services, PLLC· Glendale, AZCentricity Research Phoenix Multispecialty· Mesa, AZCalifornia Institute Renal Research· La Mesa, CAAcademic Medical Research Institute· Los Angeles, CA

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