Clinical trial NCT02892149: Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD)
Official title: Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE-CONVERSION)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Dialysis-Dependent Chronic Kidney Disease
Keywords: AKB-6548
Chronic kidney disease
anemia
CKD
chronic renal insufficiency
renal impairment
erythropoietin
kidney
renal
oral anemia treatment
hemoglobin
hypoxia-inducible factor
HIF
hypoxia-inducible factor prolyl-hydroxylase inhibitor
HIF-PHI
efficacy
safety
Phase 3
cardiovascular
DD-CKD
Lead sponsor: Akebia Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-09-08
Enrollment: 3554
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with dialysis-dependent chronic kidney disease (DD-CKD)

Detailed description: This is a multicenter, randomized, open-label, active-controlled Phase 3 study of the efficacy and safety of Vadadustat versus Darbepoetin alfa for the maintenance treatment of anemia in participants with DD-CKD

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Receiving chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease for at least 12 weeks prior to Screening
* Currently maintained on erythropoiesis-stimulating agent therapy, with a dose received within 6 weeks prior to or during Screening
* Mean Screening hemoglobin between 8.0 and 11.0 grams per deciliter (g/dL) (inclusive) in the US and between 9.0 and 12.0 g/dL (inclusive) outside of the US
* Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening

Exclusion Criteria:

* Anemia due to a cause other than chronic kidney disease or participants with active bleeding or recent blood loss
* Uncontrolled hypertension
* Red blood cell transfusion within 8 weeks prior to randomization
* Anticipated to recover adequate kidney function to no longer require dialysis
* Severe heart failure at Screening (New York Heart Association Class IV)
* Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure, or stroke within 12 weeks prior to or during Screening
* Hypersensitivity to Vadadustat, Darbepoetin alfa, or any of their excipients

Primary outcomes:
measure: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36)
timeFrame: Baseline; Weeks 24 to 36
measure: Median Time to First Major Adverse Cardiovascular Event (MACE)
timeFrame: Up to 170 weeks
Secondary outcomes:
measure: Change From Baseline in Hb to the Average Over the Secondary Efficacy Period (Weeks 40 to 52)
timeFrame: Baseline; Weeks 40 to 52
measure: Median Time to First MACE Plus Hospitalization for Heart Failure or Thromboembolic Event Excluding Vascular Access Thrombosis
timeFrame: Up to 170 weeks
measure: Median Time to First Cardiovascular MACE
timeFrame: Up to 170 weeks
measure: Median Time to First Cardiovascular Death
timeFrame: Up to 170 weeks
measure: Median Time to First All-cause Mortality
timeFrame: Up to 170 weeks
Other outcomes:
measure: Exploratory - Proportion of Participants With Hb Values Within the Target Range During the Primary Evaluation Period (Weeks 24 to 36)
timeFrame: Weeks 24 to 36
measure: Exploratory - Proportion of Time With Hb Values Within the Target Range During the Primary Evaluation Period (Weeks 24 to 36)
timeFrame: Weeks 24 to 36
measure: Exploratory - Proportion of Time With Hb Values Within the Target Range During the Secondary Evaluation Period (Weeks 40 to 52)
timeFrame: Weeks 40 to 52
measure: Exploratory - Proportion of Participants With Hb Values Within the Target Range During the Secondary Evaluation Period (Weeks 40 to 52)
timeFrame: Weeks 40 to 52
measure: Exploratory - Proportion of Participants With an Hb Increase of >1.0 g/dL From Baseline Visit
timeFrame: Baseline; up to Week 52
measure: Exploratory - Time to Achieve Hb Increase of >1.0 g/dL From Baseline Visit
timeFrame: Baseline; up to Week 52
measure: Exploratory - Mean Change in Hb Between Baseline (Mean Pretreatment Hb) and the Primary Evaluation Period (Mean Hb From Weeks 24 to 36) Stratified by Pre-baseline Erythropoiesis-stimulating Agent (ESA) Exposure
timeFrame: Baseline; Weeks 24 to 36
measure: Exploratory - Mean Monthly Dose of Intravenous (IV) Elemental Iron Administered in Participants Who Have Received IV Iron
timeFrame: Up to Week 52
measure: Exploratory - Proportion of Participants Receiving IV Iron Therapy
timeFrame: Up to Week 52
measure: Exploratory - Proportion of Participants Receiving Red Blood Cells (RBCs) Transfusion(s)
timeFrame: Up to Week 52
Locations:
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Mesa
country: United States
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state: Arizona
city: Pine Bluff
country: United States
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state: Arkansas
city: Anaheim
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state: California
city: Bakersfield
country: United States
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state: California
city: Bakersfield
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state: California
city: Canyon Country
country: United States
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city: Chula Vista
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city: Downey
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city: Escondido
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city: Fairfield
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city: Glendale
country: United States
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state: California
city: Granada Hills
country: United States
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state: California
city: Granada Hills
country: United States
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state: California
city: La Habra
country: United States
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state: California
city: La Mesa
country: United States
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state: California
city: Lakewood
country: United States
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state: California
city: Long Beach
country: United States
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state: California
city: Long Beach
country: United States
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state: California
city: Long Beach
country: United States
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state: California
city: Los Angeles
country: United States
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state: California
city: Montebello
country: United States
facility: Research Site #1
state: California
city: Monterey Park
country: United States
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state: California
city: Newhall
country: United States
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state: California
city: Northridge
country: United States
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state: California
city: Northridge
country: United States
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state: California
city: Riverside
country: United States
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city: Riverside
country: United States
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city: Roseville
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city: San Diego
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city: San Diego
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city: San Dimas
country: United States
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state: California
city: San Dimas
country: United States
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state: California
city: Simi Valley
country: United States
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city: Tarzana
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city: Whittier
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city: Arvada
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city: Denver
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city: Westminster
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city: Stamford
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city: Bradenton
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city: Coral Gables
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city: Hollywood
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city: Lauderdale Lakes
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facility: Research Site #1
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country: United States
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city: Miami
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facility: AMPM Research Clinic
state: Florida
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city: Columbus
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city: Columbus
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city: Lawrenceville
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city: Roswell
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city: Providence
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city: Chattanooga
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state: Tennessee
city: Knoxville
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facility: Research Site #2
state: Texas
city: San Antonio
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state: Utah
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city: Ciudad Autonoma Buenos Aires
country: Argentina
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state: Buenos Aires
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country: Argentina
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country: Argentina
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country: Argentina
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country: Argentina
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country: Argentina
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country: Argentina
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country: Argentina
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country: Argentina
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city: Liverpool
country: Australia
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state: New South Wales
city: New Lambton Heights
country: Australia
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city: Wahroonga
country: Australia
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city: Cairns
country: Australia
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state: Queensland
city: Launceston
country: Australia
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state: Tasmania
city: Box Hill
country: Australia
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city: Fitzroy
country: Australia
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state: Victoria
city: Nedlands
country: Australia
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state: Western Australia
city: Feira de Santana
country: Brazil
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state: Bahia
city: Itabuna
country: Brazil
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state: Bahia
city: Fortaleza
country: Brazil
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state: Ceará
city: Vitória
country: Brazil
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state: Espírito Santo
city: Belo Horizonte
country: Brazil
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state: Minas Gerais
city: Belo Horizonte
country: Brazil
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state: Minas Gerais
city: Juiz de Fora
country: Brazil
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city: Juiz de Fora
country: Brazil
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state: Minas Gerais
city: Curitiba
country: Brazil
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state: Paraná
city: Maringá
country: Brazil
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city: Canoas
country: Brazil
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city: Passo Fundo
country: Brazil
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state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
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city: Porto Alegre
country: Brazil
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state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
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state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
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state: Rio Grande Do Sul
city: Criciúma
country: Brazil
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state: Santa Catarina
city: Joinville
country: Brazil
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state: Santa Catarina
city: Santo André
country: Brazil
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state: Sao Paulo
city: Santo André
country: Brazil
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state: Sao Paulo
city: São Bernardo do Campo
country: Brazil
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state: Sao Paulo
city: São José do Rio Preto
country: Brazil
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state: Sao Paulo
city: São Paulo
country: Brazil
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state: Sao Paulo
city: São Paulo
country: Brazil
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city: São Paulo
country: Brazil
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city: Byala
country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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country: France
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city: Bordeaux
country: France
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country: France
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country: Germany
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state: Baden Wuerttemberg
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country: Germany
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city: Duesseldorf
country: Germany
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city: Berlin
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country: Israel
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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city: Goyang-si
country: Korea, Republic of
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city: Guri
country: Korea, Republic of
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city: Seongnam-si,
country: Korea, Republic of
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country: Korea, Republic of
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state: Gyeonggi-do
city: Busan
country: Korea, Republic of
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country: Korea, Republic of
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country: Mexico
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country: Mexico
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city: Morelia
country: Mexico
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city: Culiacan
country: Mexico
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city: Biala Podlaska
country: Poland
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country: Poland
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country: Poland
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city: Lodz
country: Poland
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city: Lodz
country: Poland
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city: Lodz
country: Poland
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country: Poland
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city: Beja
country: Portugal
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country: Portugal
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city: Loures
country: Portugal
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city: Ekaterinburg
country: Russian Federation
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city: Kemerovo
country: Russian Federation
facility: Research Site #2
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhniy Novgorod
country: Russian Federation
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city: Nizhniy Novgorod
country: Russian Federation
facility: Research Site
city: Novorossiysk
country: Russian Federation
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city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Site #1
city: Belgrade
country: Serbia
facility: Research Site #2
city: Belgrade
country: Serbia
facility: Research Site #3
city: Belgrade
country: Serbia
facility: Research Site #4
city: Kragujevac
country: Serbia
facility: Research Site
city: Nis
country: Serbia
facility: Research Site
city: Zajecar
country: Serbia
facility: Research Site
city: Brovary
country: Ukraine
facility: Research Site
city: Cherkassy
country: Ukraine
facility: Research Site #1
city: Dnipro
country: Ukraine
facility: Research Site
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Mykolaiv
country: Ukraine
facility: Research Site
city: Ternopil
country: Ukraine
facility: Research Site
city: Uzhgorod
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Zaporizhzhia
country: Ukraine
facility: Research Site
city: Zhytomyr
country: Ukraine
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
state: Cambridgeshire
city: London
country: United Kingdom
facility: Research Site
state: Greater London
city: Stevenage
country: United Kingdom
facility: Research Site
state: Hertfordshire
city: Kettering
country: United Kingdom
facility: Research Site
state: Leicestershire
city: Doncaster
country: United Kingdom
facility: Research Site
state: South Yorkshire
Study officials:
affiliation: Akebia Therapeutics Inc.
name: Chief Medical Officer
role: STUDY_DIRECTOR
References:
citation: Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
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