AnemiaPhase 3NCT02648347

Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease

A Phase 3 study testing Vadadustat and Darbepoetin alfa in people with Anemia and Non-Dialysis-Dependent Chronic Kidney Disease, run by Akebia Therapeutics at 439 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of anemia and maintenance of hemoglobin (Hb) in participants with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anemia, Non-Dialysis-Dependent Chronic Kidney Disease
What is being tested?: Vadadustat and Darbepoetin alfa
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,751 participants
Where: 439 sitesin 20 countries
Study dates: Dec 2015to 31 Jul 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥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
Mean Screening hemoglobin <10.0 grams per deciliter (g/dL)
Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening

Who cannot join

Anemia due to a cause other than CKD or participants with active bleeding or recent blood loss
Red blood cell transfusion within 8 weeks prior to randomization.
Any erythropoietic stimulating agent 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

Trial locations and contacts

439 sites in 20 countries.

Country

City, postcode or hospital

439 sites in 20 countries

United States208 sites

Research Site
Akron, Ohio, 44302
Research Site
Albuquerque, New Mexico, 87106
Research Site
Albuquerque, New Mexico, 87108
Research Site
Albuquerque, New Mexico, 87109
Research Site
Alexandria, Virginia, 22304
Research Site
Anaheim, California, 92801
Research Site
Anderson, Indiana, 46011
Research Site
Anderson, South Carolina, 29625
Research Site
Arlington, Texas, 76015
Research Site
Arlington, Virginia, 22207
Research Site
Arvada, Colorado, 80002
Research Site
Asheville, North Carolina, 28801
Research Site
Atlanta, Georgia, 30338
Research Site
Atlanta, Georgia, 30342
Research Site
Atlanta, Georgia, 30350
Research Site #1
Augusta, Georgia, 30909
Research Site #2
Augusta, Georgia, 30909
Research Site
Bakersfield, California, 93309
Research Site
Baltimore, Maryland, 21218
Research Site
Berlin, New Jersey, 08009
Research Site
Bradenton, Florida, 34209
Research Site
Brandon, Florida, 33511
Research Site
Butte, Montana, 59701
Research Site
Chattanooga, Tennessee, 37408
Research Site
Chicago, Illinois, 60637
Research Site #1
Chula Vista, California, 91910
Research Site #2
Chula Vista, California, 91910
Research Site
Cincinnati, Ohio, 45206
Research Site
Clinton, Utah, 84015
Research Site
Columbia, Missouri, 65201
Research Site
Columbus, Georgia, 31901
Research Site #1
Columbus, Georgia, 31904
Research Site #2
Columbus, Georgia, 31904
Research Site
Cooper City, Florida, 33024
Research Site #1
Coral Gables, Florida, 33134
Research Site #2
Coral Gables, Florida, 33134
Research Site
Coral Springs, Florida, 33065
Research Site
Coral Springs, Florida, 33071
Research Site
Dallas, Texas, 75246
Research Site
Dallas, Texas, 75390
Research Site
Danville, Virginia, 24541
Research Site
Dayton, Ohio, 45417
Research Site
Denver, Colorado, 80230
Research Site
DeSoto, Texas, 75115
Research Site
Detroit, Michigan, 48202
Research Site
Doral, Florida, 33166
Research Site
East Providence, Rhode Island, 02915
Research Site
El Paso, Texas, 79935
Research Site
Evanston, Illinois, 60201
Research Site
Flushing, New York, 11355
Research Site
Fort Myers, Florida, 33901
Research Site
Fort Wayne, Indiana, 46804
Research Site
Fort Worth, Texas, 76104
Research Site #1
Fountain Valley, California, 92708
Research Site #2
Fountain Valley, California, 92708
Research Site
Glendale, Arizona, 85306
Research Site
Glendale, California, 91206
Research Site
Gonzales, Texas, 78629
Research Site
Granada Hills, California, 91344
Research Site
Greenbelt, Maryland, 20770
Research Site #1
Greenville, North Carolina, 27834
Research Site #2
Greenville, North Carolina, 27834
Research Site
Greenville, Texas, 75401
Research Site
Greenville, Texas, 75402
Research Site
Gulfport, Mississippi, 39501
Research Site
Hampton, Virginia, 23666
Research Site
Hialeah, Florida, 33010
Research Site #1
Hialeah, Florida, 33012
Research Site #2
Hialeah, Florida, 33012
Research Site #3
Hialeah, Florida, 33012
Research Site
Hialeah, Florida, 33018
Research Site #1
Hollywood, Florida, 33024
Research Site #2
Hollywood, Florida, 33024
Research Site #1
Houston, Texas, 77004
Research Site #2
Houston, Texas, 77004
Research Site
Houston, Texas, 77030
Research Site
Houston, Texas, 77040
Research Site
Huntsville, Alabama, 35805
Research Site
Jacksonville, Florida, 32204
Research Site #1
Jacksonville, Florida, 32216
Research Site #2
Jacksonville, Florida, 32216
Research Site
Jeffersonville, Indiana, 47130
Research Site
Kansas City, Missouri, 64128
Research Site
Kinston, North Carolina, 28504
Research Site
Knoxville, Tennessee, 37923
Research Site
La Mesa, California, 91942
Research Site
Laguna Hills, California, 92653
Research Site
Lake Worth, Florida, 33467
Research Site
Lansdowne Town Center, Virginia, 20176
Research Site #1
Las Vegas, Nevada, 89106
Research Site #2
Las Vegas, Nevada, 89106
Research Site
Lauderdale Lakes, Florida, 33313
Research Site
Laurelton, New York, 11413
Research Site #1
Lawrenceville, Georgia, 30046
Research Site #2
Lawrenceville, Georgia, 30046
Research Site
Lewisville, Texas, 75057
Research Site
Lincoln, Nebraska, 68510
Research Site
Long Beach, California, 90807
Research Site
Long Beach, California, 92886
Research Site
Los Angeles, California, 90020
Research Site
Lynwood, California, 90262
Research Site
Macon, Georgia, 31217
Research Site
Madison, Wisconsin, 53705
Research Site
Marion, Ohio, 43302
Research Site
Maumee, Ohio, 43537
Research Site #1
McAllen, Texas, 78503
Research Site #2
McAllen, Texas, 78503
Research Site
McHenry, Illinois, 60050
Research Site
McKinney, Texas, 75069
Research Site
McKinney, Texas, 75071
Research Site
Memphis, Tennessee, 38104
Research Site
Meridian, Idaho, 83642
Research Site #1
Merrillville, Indiana, 46410
Research Site #2
Merrillville, Indiana, 46410
Research Site
Mesa, Arizona, 85210
Research Site
Methuen, Massachusetts, 01844
Research Site
Miami, Florida, 33122
Research Site
Miami, Florida, 33125-4141
Research Site #1
Miami, Florida, 33126
Research Site #2
Miami, Florida, 33126
Research Site
Miami, Florida, 33133
Research Site
Miami, Florida, 33134
Research Site
Miami, Florida, 33135
Research Site
Miami, Florida, 33143
Research Site
Miami, Florida, 33144
Research Site
Miami, Florida, 33145
Research Site
Miami, Florida, 33150
Research Site
Miami, Florida, 33157
Research Site
Miami, Florida, 33165
Research Site
Miami, Florida, 33169
Research Site #1
Miami, Florida, 33175
Research Site #2
Miami, Florida, 33175
Research Site
Miami Beach, Florida, 33140
Research Site
Miami Lakes, Florida, 33014
Research Site
Miami Lakes, Florida, 33016
Research Site
Miami Springs, Florida, 33166
Research Site
Michigan City, Indiana, 46360
Research Site
Monroe, Louisiana, 71201
Research Site
Morehead City, North Carolina, 28557
Research Site
Nashville, Tennessee, 37205
Research Site
New Bern, North Carolina, 28560
Research Site
New Haven, Connecticut, 06511
Research Site
New Orleans, Louisiana, 70115
Research Site
New York, New York, 10010
Research Site
Newport News, Virginia, 23606
Research Site
Norfolk, Virginia, 23507
Research Site #2
Northridge, California, 91324
Research Site
Northridge, California, 91324
Research Site
Omaha, Nebraska, 68124
Research Site
Orangeburg, South Carolina, 29118
Research Site
Pembroke Pines, Florida, 33026
Research Site
Peoria, Illinois, 61603
Research Site
Philadelphia, Pennsylvania, 19140
Research Site
Phoenix, Arizona, 85027
Research Site
Plano, Texas, 75093
Research Site
Plymouth, Massachusetts, 02360
Research Site
Pompano Beach, Florida, 33060
Research Site
Pontiac, Michigan, 48341
Research Site
Portland, Maine, 04102
Research Site
Portland, Oregon, 97216
Research Site
Portsmouth, New Hampshire, 03801
Research Site
Riverside, California, 92505
Research Site
Roseville, California, 95661
Research Site
Roseville, Michigan, 48066
Research Site
Sacramento, California, 95825
Research Site
Saint Paul, Minnesota, 55102
Research Site
Salem, Virginia, 24153
Research Site
Salinas, California, 93901
Research Site
Salt Lake City, Utah, 84115
Research Site
San Antonio, Texas, 78207
Research Site
San Antonio, Texas, 78212-4740
Research Site
San Antonio, Texas, 78224
Research Site
San Antonio, Texas, 78229
Research Site
San Antonio, Texas, 78240-1501
Research Site
San Diego, California, 92103-6204
Research Site #1
San Dimas, California, 91773
Research Site #2
San Dimas, California, 91773
Research Site
Santa Ana, California, 92704
Research Site
Santa Fe, New Mexico, 87505
Research Site
Santa Monica, California, 90404
Research Site
Sherman, Texas, 75090
Research Site
Sherman Oaks, California, 91403
Research Site #1
Shreveport, Louisiana, 71101
Research Site
Shreveport, Louisiana, 71103
Research Site
St Louis, Missouri, 63128
Research Site
Stamford, Connecticut, 06902
Research Site
Sweetwater, Florida, 33172
Research Site
Tacoma, Washington, 98405
Research Site
Takoma Park, Maryland, 20912
Research Site
Tampa, Florida, 33604
Research Site
Tampa, Florida, 33612
Research Site
Tampa, Florida, 33614
Research Site
The Bronx, New York, 10467
Research Site
Thousand Oaks, California, 91360
Research Site
Tucson, Arizona, 85718
Research Site
Tucson, Arizona, 85724
Research Site
Tuscumbia, Alabama, 35674
Research Site
Upland, California, 91786
Research Site
Victoria, Texas, 77901
Research Site
Voorhees Township, New Jersey, 08043
Research Site
Waterbury, Connecticut, 06708
Research Site
Wenatchee, Washington, 98801
Research Site
West Columbia, South Carolina, 29169
Research Site
Westminster, Colorado, 80031
Research Site #1
Whittier, California, 90603
Research Site #2
Whittier, California, 90603
Research Site
Winston-Salem, North Carolina, 27103
Research Site
Woodbridge, Virginia, 22191

Other trials in United States

Brazil29 sites

Research Site
Belo Horizonte, Minas Gerais, 30150-320
Research Site
Botucatu, São Paulo, 18618-970
Research Site
Campinas, São Paulo, 13087-567
Research Site
Canoas, Rio Grande do Sul, 92425-900
Research Site
Caxias do Sul, Rio Grande do Sul, 95010-005
Research Site
Criciúma, Santa Catarina, 88801-250
Research Site
Curitiba, Paraná, 80230-130
Research Site #1
Curitiba, Paraná, 80810-040
Research Site #2
Curitiba, Paraná, 80810-040
Research Site
Feira de Santana, Estado de Bahia, 44001-584
Research Site
Fortaleza, Ceará, 60115-282
Research Site
Fortaleza, Ceará, 60430-370
Research Site
Itabuna, Estado de Bahia, 45600-625
Research Site
Joinville, Santa Catarina, 89202-050
Research Site
Juiz de Fora, Minas Gerais, 36036-330
Research Site
Maringá, Paraná, 87060-040
Research Site
Passo Fundo, Rio Grande do Sul, 99010-080
Research Site
Porto Alegre, Rio Grande do Sul, 90035-074
Research Site
Porto Alegre, Rio Grande do Sul, 90035-903
Research Site
Porto Alegre, Rio Grande do Sul, 90160-093
Research Site
Porto Alegre, Rio Grande do Sul, 90610-000
Research Site
Rio de Janeiro, Rio Do Janeiro, 20551-030
Research Site
Santo André, São Paulo, 09080-110
Research Site
Santo André, São Paulo, 09090-790
Research Site
São Bernardo do Campo, São Paulo, 09715-090
Research Site
São Paulo, São Paulo, 01141-020
Research Site
São Paulo, São Paulo, 01406-200
Research Site
São Paulo, São Paulo, 04039-000
Research Site
Vitória, Espírito Santo, 29055-450

Other trials in Brazil

Argentina26 sites

Research Site
Bahía Blanca, Buenos Aires, B8001HXM
Research Site
Ciudad Autonoma Buenos Aires, C1093AAS
Research Site
Ciudad Autonoma Buenos Aires, C1430CKE
Research Site
Córdoba, 5000
Research Site
Córdoba, X5000AAW
Research Site
Córdoba, X5000EVQ
Research Site
Córdoba, X5020AAA
Research Site
Corrientes, 3400
Research Site
Godoy Cruz, Mendoza Province, 5501
Research Site
Junín, Buenos Aires, 6000
Research Site
Junín, Buenos Aires, B6000BHA
Research Site
Mar del Plata, Buenos Aires, B7600FYK
Research Site
Mar del Plata, Buenos Aires, B7600FZ
Research Site
Pergamino, Buenos Aires, B2700CPM
Research Site
Ramos Mejía, Buenos Aires, B1704ETD
Research Site
Rosario, Santa Fe Province, S2000DIF
Research Site
Salta, 4406
Research Site
San Luis, 5700
Research Site
San Miguel, Buenos Aires, B1663CNJ
Research Site
San Miguel de Tucumán, Tucumán Province, 4000
Research Site
San Miguel de Tucumán, Tucumán Province, T4000AXL
Research Site
San Miguel de Tucumán, Tucumán Province, T4000ICL
Research Site
San Miguel de Tucumán, Tucumán Province, T4000
Research Site
San Nicolás de los Arroyos, Buenos Aires, B2900DMH
Research Site
Sarandí, Buenos Aires, B1872EEA
Research Site
Temperley, Buenos Aires, 1834

Other trials in Argentina

Ukraine20 sites

Research Site
Dnipro, 49005
Research Site
Ivano-Frankivsk, 76008
Research Site
Ivano-Frankivsk, 76018
Research Site
Kharkiv, 61037
Research Site
Kharkiv, 61039
Research Site
Kharkiv, 61103
Research Site
Kharkiv, 61157
Research Site
Kropyvnytskyi, 25006
Research Site
Kyiv, 02125
Research Site
Kyiv, 04050
Research Site
Lviv, 79010
Research Site
Lviv, 79013
Research Site
Mykolaiv, 54058
Research Site
Odesa, 65025
Research Site
Vinnytsia, 21001
Research Site
Vinnytsia, 21005
Research Site
Vinnytsia, 21018
Research Site
Zaporizhzhya, 69118
Research Site
Zaporizhzhya, 69600
Research Site
Zhytomyr, 10002

Other trials in Ukraine

Mexico19 sites

Research Site
Acapulco de Juárez, Guerrero, 39670
Research Site
Chihuahua City, 31203
Research Site
Chihuahua City, 31217
Research Site
Culiacán, Sinaloa, 80030
Research Site
Culiacán, Sinaloa, 80200
Research Site
Culiacán, Sinaloa, 80230
Research Site
Durango, 34000
Research Site
Guadalajara, Jalisco, 44130
Research Site
Mazatlán, Sinaloa, 82110
Research Site
Mexico City, Mexico City, 06100
Research Site
Mexico City, Mexico City, 06700
Research Site
Monterrey, Nuevo León, 64710
Research Site
Morelia, Michoacán, 58260
Research Site
Pachuca, Hidalgo, 42070
Research Site
Pachuca, Hidalgo, 42090
Research Site
San Juan del Río, Querétaro, 76800
Research Site
Veracruz, 91900
Research Site
Zapopan, Jalisco, 45116
Research Site
Zapopan, Jalisco, 45200

Other trials in Mexico

Bulgaria18 sites

Research Site
Dobrich, 9300
Research Site
Lom, 3600
Research Site
Silistra, 7500
Research Site
Sliven, 8800
Research Site
Smolyan, 4700
Research Site
Sofia, 1233
Research Site
Sofia, 1407
Research Site #1
Sofia, 1431
Research Site #2
Sofia, 1431
Research Site
Sofia, 1606
Research Site
Sofia, 1784
Research Site
Stara Zagora, 6000
Research Site
Stara Zagora, 6003
Research Site
Varna, 9000
Research Site
Varna, 9002
Research Site #1
Veliko Tarnovo, 5000
Research Site #2
Veliko Tarnovo, 5000
Research Site
Vidin, 3700

Other trials in Bulgaria

Russia17 sites

Research Site
Kazan', 420012
Research Site
Kemerovo, 650066
Research Site
Krasnoyarsk, 660062
Research Site
Moscow, 115516
Research Site
Nizhny Novgorod, 603076
Research Site
Novosibirsk, 630008
Research Site
Novosibirsk, 630054
Research Site
Novosibirsk, 630091
Research Site
Petrozavodsk, 185019
Research Site
Pushkin, 196603
Research Site
Saint Petersburg, 195271
Research Site
Saint Petersburg, 197022
Research Site
Saint Petersburg, 199106
Research Site
Saint Petersburg, 199226
Research Site
Tomsk, 634050
Research Site
Tosno, 187000
Research Site
Yaroslavl, 150062

Other trials in Russia

South Africa17 sites

Research Site
Bloemfontein, Free State, 9301
Research Site
Cape Town, Western Cape, 7925
Research Site #1
Durban, KwaZulu-Natal, 4001
Research Site #2
Durban, KwaZulu-Natal, 4001
Research Site
Durban, KwaZulu-Natal, 4092
Research Site
Durban, KwaZulu-Natal, 4096
Research Site
Durban, KwaZulu-Natal, 4320
Research Site
George, Western Cape, 6529
Research Site
Port Elizabeth, Eastern Cape, 6001
Research Site #1
Pretoria, Gauteng, 0002
Research Site #2
Pretoria, Gauteng, 0002
Research Site
Pretoria, Gauteng, 1692
Research Site
Somerset West, Western Cape, 7130
Research Site
Tongaat, KwaZulu-Natal, 4399
Research Site
Vereeniging, Gauteng, 1935
Research Site
Winnie Mandela, Free State, 9400
Research Site
Worcester, Western Cape, 6850

Other trials in South Africa

Hungary15 sites

Research Site #1
Baja, 6500
Research Site #2
Baja, 6500
Research Site
Balatonfüred, 8230
Research Site
Budapest, 1076
Research Site
Budapest, 1145
Research Site
Debrecen, 4032
Research Site
Hódmezővásárhely, 6800
Research Site
Kalocsa, 6300
Research Site
Kaposvár, 7400
Research Site
Kecskemét, 6000
Research Site
Kistarcsa, 2143
Research Site
Nyíregyháza, 4400
Research Site
Pécs, 7623
Research Site
Szeged, 6720
Research Site
Szigetvár, 7900

Other trials in Hungary

Italy14 sites

Research Site
Bari, 70124
Research Site
Bergamo, 24127
Research Site
Cremona, 26100
Research Site
Genova, 16132
Research Site
Lecco, 23900
Research Site
Milan, 20142
Research Site
Naples, 80131
Research Site
Naples, 80138
Research Site
Parma, 43100
Research Site
Pavia, 27100
Research Site
Piedimonte Matese, Caserta, 81016
Research Site
Roma, 00168
Research Site
San Giovanni Rotondo, Foggia, 71013
Research Site
Siena, 53100

Other trials in Italy

Spain14 sites

Research Site
Almería, 04007
Research Site
Almería, 04009
Research Site
Badajoz, 06006
Research Site
Barcelona, 08003
Research Site
Elche, Alicante, 03293
Research Site
L'Hospitalet de Llobregat, Barcelona, 08907
Research Site
Madrid, 28041
Research Site
Málaga, Málaga, 29010
Research Site
Palma de Mallorca, Balearic Islands, 07120
Research Site
Seville, 41013
Research Site
Seville, 41071
Research Site
Torrevieja, Alicante, 03186
Research Site
Valencia, 46014
Research Site
Valencia, 46026

Other trials in Spain

Australia10 sites

Research Site
Adelaide, South Australia, 5000
Research Site
Bedford Park, South Australia, 5042
Research Site
Box Hill, Victoria, 3128
Research Site
Cairns, Queensland, 4870
Research Site
Camperdown, New South Wales, 2050
Research Site
Gold Coast, Queensland, 9726
Research Site
Herston, Queensland, 4006
Research Site
Liverpool, New South Wales, 2170
Research Site
Nedlands, Western Australia, 6009
Research Site
Perth, Western Australia, 6000

Other trials in Australia

United Kingdom9 sites

Research Site
Aberdeen, Grampian Region, AB25 2ZB
Research Site
Doncaster, South Yorkshire, DN2 5LT
Research Site
Leicester, Leicestershire, LE5 4PW
Research Site
London, Greater London, E1 1BB
Research Site
London, Greater London, SE5 9RS
Research Site
Salford, Greater Manchester, M6 8HD
Research Site
Sheffield, South Yorkshire, S5 7AU
Research Site
Stevenage, Hertfordshire, SG1 4AB
Research Site
Swansea, SA6 6NL

Other trials in United Kingdom

South Korea7 sites

Research Site
Bucheon-si, Gyeonggi-do, 14647
Research Site
Busan, 47392
Research Site
Busan, 49201
Research Site
Daegu, 41944
Research Site
Guri-si, Gyeonggi-do, 11923
Research Site
Seoul, 02841
Research Site
Seoul, 03080

Other trials in South Korea

Israel5 sites

Research Site
Ashkelon, 78278
Research Site
Haifa, 3109601
Research Site
Nahariya, 2210001
Research Site
Ramat Gan, 52363
Research Site
Rishon LeZiyyon, 75141

Other trials in Israel

Poland5 sites

Research Site
Lodz, 90-153
Research Site
Lodz, 93-338
Research Site
Nowa Sól, 67-100
Research Site
Warsaw, 04-749
Research Site
Wroclaw, 50-414

Other trials in Poland

Malaysia2 sites

Research Site
Kota Bharu, Kelantan, 15586
Research Site
Kuantan, Pahang, 25100

Other trials in Malaysia

New Zealand2 sites

Research Site
Hamilton, 3200
Research Site
New Plymouth, 4342

Other trials in New Zealand

France1 site

Research Site
Pontoise, Val d'Oise, 95300

Other trials in France

Puerto Rico1 site

Research Site
Caguas, 00725

Other trials in Puerto Rico

About this study

Official title: Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction of Anemia in Subjects With Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CORRECTION)

Read the 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 correction of anemia and maintenance of Hb in participants with NDD-CKD

Conditions: Anemia, Non-Dialysis-Dependent Chronic Kidney Disease
Being tested: Vadadustat, Darbepoetin alfa
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
Medical subject headings: Anemia, Renal Insufficiency, Chronic, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VadadustatDrug
Also called AKB-6548
Oral dose administered once daily for ≥36 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
Darbepoetin alfaDrug
Also called Aranesp
Subcutaneous or intravenous dose administered for ≥36 weeks. Initial dose based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics for all other investigational sites (non-US) for adult participants with chronic kidney disease not on dialysis.

Study groups in NCT02648347
Study group	Role	What they receive
Vadadustat	Experimental	Not described Receives: Drug: Vadadustat
Darbepoetin alfa	Active comparator	Not described Receives: Drug: Darbepoetin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36)
The Baseline average was calculated as the average of the Hb values obtained at the screening visit closest to the date of randomization and the randomization visit. The average for the Primary Efficacy Period was calculated as the average Hb value over Weeks 24 to 36. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with Baseline Hb concentration (<9.5 versus ≥9.5 grams per deciliter [g/dL]), geographic region (United States [US] versus European Union [EU] versus Rest of World [ROW]), and New York Heart Association congestive heart failure (NYHA CHF) class (Class 0 [no CHF] or I versus II or III) as covariates.
Measured: Baseline; Weeks 24 to 36
Median Time to First Major Adverse Cardiovascular Event (MACE)
MACE was defined as all-cause mortality, non-fatal myocardial infarction (MI), or non-fatal stroke. The primary safety outcome was positively adjudicated first MACE, which was defined as any death, Endpoint Adjudication Committee (EAC)-confirmed non-fatal MI, or EAC-confirmed non-fatal stroke occurring between the first dose date and each participant's last participation date. PROTECT MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Results and statistical analysis from study AKB-6548-CI-0014 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0014 and AKB-6548-CI-0015 has been reported under section "Statistical Analysis 2" of this outcome measure.
Measured: Up to Week 208

Secondary outcomes (5)

Change From Baseline in Hb to the Average Over the Secondary Efficacy Period (Weeks 40 to 52)
The Baseline average was calculated as the average of the Hb values obtained at the screening visit closest to the date of randomization and the randomization visit. The average for the Secondary Efficacy Period was calculated as the average Hb value over Weeks 40 to 52. Analysis was conducted using an ANCOVA model with multiple imputation for missing data with Baseline Hb concentration (<9.5 versus ≥9.5 g/dL), geographic region (US versus EU versus ROW), and NYHA CHF class (Class 0 [no CHF] or I versus II or III) as covariates.
Measured: Baseline; Weeks 40 to 52
Median Time to First MACE Plus Hospitalization for Heart Failure or Thromboembolic Event Excluding Vascular Access Thrombosis
MACE was defined as all-cause mortality, non-fatal MI, or non-fatal stroke. Hospitalization for EAC adjudicated heart failure included presentation of participants to an acute care facility requiring an overnight hospitalization (change in calendar day) with an exacerbation of heart failure requiring treatment. EAC confirmed thromboembolic events for this secondary outcome measure included arterial thrombosis, deep vein thrombosis, and pulmonary embolism. PROTECT MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Results and statistical analysis from study AKB-6548-CI-0014 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0014 and AKB-6548-CI-0015 has been reported under section "Statistical Analysis 2" of this outcome measure.
Measured: Up to Week 208
Median Time to First Cardiovascular MACE
MACE was defined as all-cause mortality, non-fatal MI, or non-fatal stroke. Cardiovascular MACE analysis differed from the primary MACE endpoint as it included only deaths adjudicated by the EAC as cardiovascular deaths (i.e, only EAC-confirmed cardiovascular deaths) in addition to first events of non-fatal MI or non-fatal stroke. PROTECT MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Results and statistical analysis from study AKB-6548-CI-0014 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0014 and AKB-6548-CI-0015 has been reported under section "Statistical Analysis 2" of this outcome measure.
Measured: Up to Week 208
Median Time to First Cardiovascular Death
Cardiovascular death included EAC adjudicated fatal MI, pump failure, sudden death, presumed sudden death, fatal stroke, fatal pulmonary embolism, cardiovascular procedure-related death, other cardiovascular death, and presumed cardiovascular death. PROTECT MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Results and statistical analysis from study AKB-6548-CI-0014 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0014 and AKB-6548-CI-0015 has been reported under section "Statistical Analysis 2" of this outcome measure.
Measured: Up to Week 208
Median Time to First All-cause Mortality
Only events that were positively adjudicated and confirmed by the EAC were included in the MACE analyses. PROTECT MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Results and statistical analysis from study AKB-6548-CI-0014 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0014 and AKB-6548-CI-0015 has been reported under section "Statistical Analysis 2" of this outcome measure.
Measured: Up to Week 208

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 201531 Jul 2020

First posted7 Jan 2016 (estimated)
Study startDec 2015
Primary completion4 Jun 2020
Study completion31 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for AnemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,751 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02648347
Sponsor's protocol ID: AKB-6548-CI-0014
Other IDs: 2015-004265-81, 2015
Status last verified: Jun 2022
First submitted: 4 Jan 2016
Last updated: 27 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Chertow GM, Eckardt KU, Sarnak MJ, Winkelmayer WC, Agarwal R, Minga T, Luo W, Burke SK. Safety and Efficacy of Vadadustat for the Treatment of CKD-Related Anemia within and outside the United States. J Am Soc Nephrol. 2025 Oct 1;36(10):1984-1997. doi: 10.1681/ASN.0000000708. Epub 2025 May 13.
PubMed 40359056
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.
PubMed 36005278
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.
PubMed 33913637

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome

All Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction of Anemia in Subjects With Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CORRECTION)
ClinicalTrials.gov ID: NCT02648347
Acronym / sponsor ID: AKB-6548-CI-0014
Conditions: Anemia, Non-Dialysis-Dependent Chronic Kidney Disease
Keywords: Vadadustat, AKB-6548, Chronic kidney disease, anemia, CKD, chronic renal insufficiency, renal impairment, erythropoietin
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,751 participants (actual)
Lead sponsor: Akebia TherapeuticsIndustry (pharma, biotech, devices)
Study start: Dec 2015 (actual)
Primary completion: 4 Jun 2020 (actual)
Study completion: 31 Jul 2020 (actual)
First posted: 7 Jan 2016 (estimated)
Results: Posted 27 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Vadadustat	Experimental	Drug: Vadadustat
Darbepoetin alfa	Active comparator	Drug: Darbepoetin alfa

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

≥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
Mean Screening hemoglobin <10.0 grams per deciliter (g/dL)
Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening

Key exclusion criteria (7 listed)

Anemia due to a cause other than CKD or participants with active bleeding or recent blood loss
Red blood cell transfusion within 8 weeks prior to randomization.
Any erythropoietic stimulating agent within 8 weeks prior to randomization
Uncontrolled hypertension
Severe heart failure at Screening (New York Heart Association Class IV)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VadadustatAlso: AKB-6548Oral dose administered once daily for ≥36 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.	Drug	Vadadustat
Darbepoetin alfaAlso: AranespSubcutaneous or intravenous dose administered for ≥36 weeks. Initial dose based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics for all other investigational sites (non-US) for adult participants with chronic kidney disease not on dialysis.	Drug	Darbepoetin alfa

Primary outcome

Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36)
Time frame: Baseline; Weeks 24 to 36
The Baseline average was calculated as the average of the Hb values obtained at the screening visit closest to the date of randomization and the randomization visit. The average for the Primary Efficacy Period was calculated as the average Hb value over Weeks 24 to 36. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with Baseline Hb concentration (<9.5 versus ≥9.5 grams per deciliter [g/dL]), geographic region (United States [US] versus European Union [EU] versus Rest of World [ROW]), and New York Heart Association congestive heart failure (NYHA CHF) class (Class 0 [no CHF] or I versus II or III) as covariates.
Median Time to First Major Adverse Cardiovascular Event (MACE)
Time frame: Up to Week 208
MACE was defined as all-cause mortality, non-fatal myocardial infarction (MI), or non-fatal stroke. The primary safety outcome was positively adjudicated first MACE, which was defined as any death, Endpoint Adjudication Committee (EAC)-confirmed non-fatal MI, or EAC-confirmed non-fatal stroke occurring between the first dose date and each participant's last participation date. PROTECT MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Results and statistical analysis from study AKB-6548-CI-0014 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0014 and AKB-6548-CI-0015 has been reported under section "Statistical Analysis 2" of this outcome measure.

5 secondary outcomes

Change From Baseline in Hb to the Average Over the Secondary Efficacy Period (Weeks 40 to 52)
Time frame: Baseline; Weeks 40 to 52
Median Time to First MACE Plus Hospitalization for Heart Failure or Thromboembolic Event Excluding Vascular Access Thrombosis
Time frame: Up to Week 208
Median Time to First Cardiovascular MACE
Time frame: Up to Week 208
Median Time to First Cardiovascular Death
Time frame: Up to Week 208
Median Time to First All-cause Mortality
Time frame: Up to Week 208

Results and safety

Results posted to the registry on 27 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vadadustat	879	670
Darbepoetin Alfa	872	675

Primary outcome: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36)

Time frame: Baseline; Weeks 24 to 36. Least squares mean (Standard Error). Unit: g/dL

Measure	Vadadustat n = 879	Darbepoetin Alfa n = 872
Value	1.43 (0.046)	1.38 (0.047)

Vadadustat vs Darbepoetin Alfa: Least squares mean difference: 0.05 (95% CI -0.04 to 0.15)

Population analysed: Randomized Population: All participants randomized. Analyses of this population were based on the randomized treatment.

Primary outcome: Median Time to First Major Adverse Cardiovascular Event (MACE)

Time frame: Up to Week 208. Median (Inter-Quartile Range). Unit: Weeks

Measure	Vadadustat n = 214	Darbepoetin Alfa n = 192
Value	45.71 (21.71 to 83.14)	46.71 (25.93 to 85.57)

Vadadustat vs Darbepoetin Alfa: Hazard Ratio (HR): 1.16 (95% CI 0.955 to 1.412), p =0.2050, Log Rank
Vadadustat vs Darbepoetin Alfa: Hazard Ratio (HR): 1.17 (95% CI 1.012 to 1.355), p =0.0725, Log Rank

Population analysed: Safety Population (PRO2TECT): All participants from the PRO2TECT (Non-dialysis-dependent chronic kidney disease \[NDD-CKD\]) population who received 1 or more doses of study drug. Only those participants with MACE events were analyzed for this outcome measure.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 208 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vadadustat	573 of 878 (65.3%)	561 of 878 (63.9%)	180 of 878
Darbepoetin Alfa	561 of 870 (64.5%)	565 of 870 (64.9%)	168 of 870

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40359056Chertow GM, Eckardt KU, Sarnak MJ, Winkelmayer WC, Agarwal R, Minga T, Luo W, Burke SK. Safety and Efficacy of Vadadustat for the Treatment of CKD-Related Anemia within and outside the United States. J Am Soc Nephrol. 2025 Oct 1;36(10):1984-1997. doi: 10.1681/ASN.0000000708. Epub 2025 May 13.
Derived from this study: PubMed 36005278Natale 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.
Derived from this study: PubMed 33913637Chertow 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.
Individual participant dataSharing planned: No

Related trials for Anemia

RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chief Medical Officer study director

Akebia Therapeutics

439 sites in 20 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vadadustat and Darbepoetin alfa in people with Anemia and Non-Dialysis-Dependent Chronic Kidney Disease, run by Akebia Therapeutics at 439 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 439 sites in United States, Brazil, Argentina, Ukraine, Mexico and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) (time frame: Baseline; Weeks 24 to 36). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02648347, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.