Clinical trial NCT02680574: Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-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 Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CONVERSION)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Non-Dialysis-Dependent Chronic Kidney Disease
Keywords: Vadadustat
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
NDD-CKD
Lead sponsor: Akebia Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-02-11
Enrollment: 1725
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 Non-dialysis-dependent Chronic Kidney Disease (NDD-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 NDD-CKD

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Diagnosis of chronic kidney disease (CKD) with an estimated glomerular filtration rate ≤60 milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2) at Screening and not expected to start dialysis within 6 months of Screening
* Currently maintained on erythropoiesis-stimulating agents 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 United States (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 CKD or participant with active bleeding or recent blood loss
* Red blood cell transfusion within 8 weeks prior to randomization
* Uncontrolled hypertension
* 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 Darbepoetin or Vadadustat or to 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 Week 208
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 Week 208
measure: Median Time to First Cardiovascular MACE
timeFrame: Up to Week 208
measure: Median Time to First Cardiovascular Death
timeFrame: Up to Week 208
measure: Median Time to First All-cause Mortality
timeFrame: Up to Week 208
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: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Huntsville
country: United States
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facility: Research Site
state: Rio Do Janeiro
city: Caxias do Sul
country: Brazil
facility: Research Site
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Research Site
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Research Site
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Research Site
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Research Site
state: Rio Grande Do Sul
city: Criciúma
country: Brazil
facility: Research Site
state: Santa Catarina
city: Joinville
country: Brazil
facility: Research Site
state: Santa Catarina
city: Botucatu
country: Brazil
facility: Research Site
state: Sao Paulo
city: Campinas
country: Brazil
facility: Research Site
state: Sao Paulo
city: Santo André
country: Brazil
facility: Research Site
state: Sao Paulo
city: Santo André
country: Brazil
facility: Research Site
state: Sao Paulo
city: São Bernardo do Campo
country: Brazil
facility: Research Site
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Research Site
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Research Site
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Research Site
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Research Site
state: Sao Paulo
city: Byala
country: Bulgaria
facility: Research Site
city: Cherven bryag
country: Bulgaria
facility: Research Site
city: Lom
country: Bulgaria
facility: Research Site
city: Silistra
country: Bulgaria
facility: Research Site
city: Sliven
country: Bulgaria
facility: Research Site
city: Smolyan
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site #1
city: Sofia
country: Bulgaria
facility: Research Site #2
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Stara Zagora
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Veliko Tarnovo
country: Bulgaria
facility: Research Site
city: Vratsa
country: Bulgaria
facility: Research Site
city: Scarborough
country: Canada
facility: Research Site
state: Ontario
city: Concepción
country: Chile
facility: Research Site
city: Puerto Varas
country: Chile
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Temuco
country: Chile
facility: Research Site
city: Barranquilla
country: Colombia
facility: Research Site
city: Bogota
country: Colombia
facility: Research Site
city: Espinal
country: Colombia
facility: Research Site
city: Manizales
country: Colombia
facility: Research Site
city: Medellin
country: Colombia
facility: Research Site #1
city: Medellin
country: Colombia
facility: Research Site #2
city: Medellín
country: Colombia
facility: Research Site
city: Ceske Budejovice
country: Czechia
facility: Research Site
city: Hradec Kralove
country: Czechia
facility: Research Site
city: Praha 2
country: Czechia
facility: Research Site
city: Praha 4
country: Czechia
facility: Research Site
city: Lille
country: France
facility: Research Site
state: Alpes De Haute Provence
city: Saint-Priest-En-Jarez
country: France
facility: Research Site
state: Loire
city: Reims Cedex
country: France
facility: Research Site
state: Marne
city: Pontoise
country: France
facility: Research Site
state: Val d'Oise
city: Créteil Cedex
country: France
facility: Research Site
state: Val De Marne
city: Paris
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Villingen-Schwenningen
country: Germany
facility: Research Site
state: Baden Wuerttemberg
city: Rostock
country: Germany
facility: Research Site
state: Mecklenburg Vorpommern
city: Duesseldorf
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Baja
country: Hungary
facility: Research Site #1
city: Baja
country: Hungary
facility: Research Site #2
city: Balatonfured
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Esztergom
country: Hungary
facility: Research Site
city: Hodmezovasarhely
country: Hungary
facility: Research Site
city: Kalocsa
country: Hungary
facility: Research Site
city: Kaposvar
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Kistarcsa
country: Hungary
facility: Research Site
city: Pecs
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Szigetvar
country: Hungary
facility: Research Site
city: Ashkelon
country: Israel
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Nahariya
country: Israel
facility: Research Site
city: Ramat Gan
country: Israel
facility: Research Site
city: Rishon Lezion
country: Israel
facility: Research Site
city: Piedimonte Matese
country: Italy
facility: Research Site
state: Caserta
city: San Giovanni Rotondo
country: Italy
facility: Research Site
state: Foggia
city: Bari
country: Italy
facility: Research Site
city: Lecco
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site #1
city: Napoli
country: Italy
facility: Research Site #2
city: Parma
country: Italy
facility: Research Site
city: Pavia
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Siena
country: Italy
facility: Research Site
city: Bucheon-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Guri-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Research Site
city: Busan
country: Korea, Republic of
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Alor Setar
country: Malaysia
facility: Research Site
state: Kedah
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Pulau Pinang
country: Malaysia
facility: Research Site
city: Torreon
country: Mexico
facility: Research Site
state: Coahuila
city: Mexico
country: Mexico
facility: Research Site
state: Distrito Federal
city: Mexico
country: Mexico
facility: Research Site
state: Distrito Federal
city: Acapulco de Juarez
country: Mexico
facility: Research Site
state: Guerrero
city: Pachuca
country: Mexico
facility: Research Site #1
state: Hidalgo
city: Pachuca
country: Mexico
facility: Research Site #2
state: Hidalgo
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Zapopan
country: Mexico
facility: Research Site
state: Jalisco
city: Zapopan
country: Mexico
facility: Research Site
state: Jalisco
city: Zapopan
country: Mexico
facility: Research Site
state: Jalisco
city: Morelia
country: Mexico
facility: Research Site
state: Michoacán
city: Monterrey
country: Mexico
facility: Research Site
state: Nuevo León
city: Monterrey
country: Mexico
facility: Research Site
state: Nuevo León
city: San Juan del Rio
country: Mexico
facility: Research Site
state: Queretaro
city: Culiacan
country: Mexico
facility: Research Site
state: Sinaloa
city: Culiacan
country: Mexico
facility: Research Site
state: Sinaloa
city: Culiacán
country: Mexico
facility: Research Site
state: Sinaloa
city: Mazatlan
country: Mexico
facility: Research Site
state: Sinaloa
city: Chihuahua
country: Mexico
facility: Research Site
city: Chihuahua
country: Mexico
facility: Research Site
city: Durango
country: Mexico
facility: Research Site
city: Veracruz
country: Mexico
facility: Research Site
city: Hamilton
country: New Zealand
facility: Research Site
city: New Plymouth
country: New Zealand
facility: Research Site
city: Nowa Sol
country: Poland
facility: Research Site
city: Caguas
country: Puerto Rico
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site #1
city: Bucuresti
country: Romania
facility: Research Site #2
city: Bucuresti
country: Romania
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Petrozavodsk
country: Russian Federation
facility: Research Site
city: Pushkin
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: Yaroslavl
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: Kragujevac
country: Serbia
facility: Research Site
city: Lazarevac
country: Serbia
facility: Research Site
city: Nis
country: Serbia
facility: Research Site
city: Zajecar
country: Serbia
facility: Research Site
city: Bardejov
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Galanta
country: Slovakia
facility: Research Site
city: Svidnik
country: Slovakia
facility: Research Site
city: Trstena
country: Slovakia
facility: Research Site
city: Bloemfontein
country: South Africa
facility: Research Site
state: Free State
city: Brandfort
country: South Africa
facility: Research Site
state: Free State
city: Pretoria
country: South Africa
facility: Research Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Research Site
state: Gauteng
city: Vereeniging
country: South Africa
facility: Research Site
state: Gauteng
city: Durban
country: South Africa
facility: Research Site #1
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Research Site #2
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Research Site
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Research Site
state: KwaZulu-Natal
city: Tongaat
country: South Africa
facility: Research Site
state: KwaZulu-Natal
city: Worcester
country: South Africa
facility: Research Site
state: Western Cape
city: Elche
country: Spain
facility: Research Site
state: Alicante
city: Torrevieja
country: Spain
facility: Research Site
state: Alicante
city: Palma de Mallorca
country: Spain
facility: Research Site
state: Baleares
city: L'Hospitalet de Llobregat
country: Spain
facility: Research Site
state: Barcelona
city: Malaga
country: Spain
facility: Research Site
state: Málaga
city: Almeria
country: Spain
facility: Research Site
city: Almeria
country: Spain
facility: Research Site
city: Badajoz
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Pamplona
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Erciyes
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Kocaeli
country: Turkey
facility: Research Site
city: Dnipro
country: Ukraine
facility: Research Site
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kropyvnytskyi
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Lutsk
country: Ukraine
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site
city: Mykolaiv
country: Ukraine
facility: Research Site
city: Odesa
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Zaporizhzhia
country: Ukraine
facility: Research Site
city: Exeter
country: United Kingdom
facility: Research Site
state: Devon
city: London
country: United Kingdom
facility: Research Site
state: Greater London
city: London
country: United Kingdom
facility: Research Site
state: Greater London
city: Salford
country: United Kingdom
facility: Research Site
state: Greater Manchester
city: Stevenage
country: United Kingdom
facility: Research Site
state: Hertfordshire
city: Leicester
country: United Kingdom
facility: Research Site
state: Leicestershire
city: King's Lynn
country: United Kingdom
facility: Research Site
state: Norfolk
city: Doncaster
country: United Kingdom
facility: Research Site
state: South Yorkshire
city: Swansea
country: United Kingdom
facility: Research Site
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.
citation: Chertow GM, Pergola PE, Farag YMK, Agarwal R, Arnold S, Bako G, Block GA, Burke S, Castillo FP, Jardine AG, Khawaja Z, Koury MJ, Lewis EF, Lin T, Luo W, Maroni BJ, Matsushita K, McCullough PA, Parfrey PS, Roy-Chaudhury P, Sarnak MJ, Sharma A, Spinowitz B, Tseng C, Tumlin J, Vargo DL, Walters KA, Winkelmayer WC, Wittes J, Eckardt KU; PRO2TECT Study Group. Vadadustat in Patients with Anemia and Non-Dialysis-Dependent CKD. N Engl J Med. 2021 Apr 29;384(17):1589-1600. doi: 10.1056/NEJMoa2035938.