Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Roxadustat for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

The purpose of the study is to evaluate the safety and efficacy of roxadustat for treatment of anemia in patients with chronic kidney disease not on dialysis

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: Roxadustat; Drug: Placebo

Detailed Description

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in anemic patients with Stage 3, 4 or 5 chronic kidney disease (CKD) who are not on dialysis.

• Study Type: Interventional
• Enrollment (Actual): 2781
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, C1012AAR
    • Research Site
  • Caba, Argentina, C1440AAD
    • Research Site
  • Capital Federal, Argentina, C1425AGC
    • Research Site
  • Ciudad Autónoma de Bs. As., Argentina, C1199ABB
    • Research Site
  • Ciudadela, Argentina, 1702
    • Research Site
  • La Plata, Argentina, 1900
    • Research Site
  • La Plata, Argentina, C1427ARO
    • Research Site
  • Lanus, Argentina, B1824KAJ
    • Research Site
  • Mar del Plata, Argentina, 7600
    • Research Site
  • Munro, Argentina, 1605
    • Research Site
  • Ramos Mejía, Argentina, B1704ETD
    • Research Site
  • Rosario, Argentina, 2000
    • Research Site
  • Rosario, Argentina, S2000DNM
    • Research Site
  • San Isidro, Argentina, B1642DCD
    • Research Site
  • San Miguel de Tucuman, Argentina, 4000
    • Research Site
  • Santa Rosa, Argentina, 6300
    • Research Site
• Brazil
  • Curitiba, Brazil, 80230-130
    • Research Site
  • Curitiba, Brazil, 80440-020
    • Research Site
  • Curitiba, Brazil, 80810-040
    • Research Site
  • Feira de Santana, Brazil, 44001-584
    • Research Site
  • Fortaleza, Brazil, 60115282
    • Research Site
  • Fortaleza, Brazil, 60430-350
    • Research Site
  • Fortaleza, Brazil, 60430-370
    • Research Site
  • Goiânia, Brazil, 74043-011
    • Research Site
  • Joinville, Brazil
    • Research Site
  • Juiz de Fora, Brazil, 36036-330
    • Research Site
  • Maringa, Brazil, 87083-240
    • Research Site
  • Porto Alegre, Brazil, 90035-003
    • Research Site
  • Porto Alegre, Brazil, 90610-000
    • Research Site
  • Porto Alegre, Brazil, 90160-093
    • Research Site
  • Sao Bernardo do Campo, Brazil, 09715090
    • Research Site
  • Sao Paulo, Brazil, 05403-000
    • Research Site
  • Sao Paulo, Brazil, 01323-030
    • Research Site
  • Sao Paulo, Brazil, 08270-070
    • Research Site
  • São Paulo, Brazil, 04039-000
    • Research Site
• Bulgaria
  • Botevgrad, Bulgaria, 2140
    • Research Site
  • Dupnitsa, Bulgaria, 2600
    • Research Site
  • Gotse Delchev, Bulgaria, 2900
    • Research Site
  • Haskovo, Bulgaria, 6300
    • Research Site
  • Kozloduy, Bulgaria, 3320
    • Research Site
  • Samokov, Bulgaria, 2000
    • Research Site
  • Sandanski, Bulgaria, 2800
    • Research Site
  • Silistra, Bulgaria, 7500
    • Research Site
  • Sliven, Bulgaria, 8800
    • Research Site
  • Smolyan, Bulgaria, 3700
    • Research Site
  • Yambol, Bulgaria, 8600
    • Research Site
• Canada
  • Quebec, Canada, G1R 2J6
    • Research Site
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Research Site
  • British Columbia
    • Kamloops, British Columbia, Canada, V2C 2T1
      • Research Site
    • New Westminster, British Columbia, Canada, V3L 0A6
      • Research Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2V 3M3
      • Research Site
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Research Site
  • Nova Scotia
    • Sydney, Nova Scotia, Canada, B1P 1P3
      • Research Site
  • Ontario
    • Brampton, Ontario, Canada, L6R 3J7
      • Research Site
    • Brampton, Ontario, Canada, L6T 0G1
      • Research Site
    • Kitchener, Ontario, Canada, N2H 5Z8
      • Research Site
    • London, Ontario, Canada, N6A 5A5
      • Research Site
    • Oakville, Ontario, Canada, L6K 3V3
      • Research Site
    • Scarborough, Ontario, Canada, M1H 3G4
      • Research Site
    • Toronto, Ontario, Canada, M4C 5T2
      • Research Site
    • Toronto, Ontario, Canada, M4S 1Y2
      • Research Site
    • Toronto, Ontario, Canada, M5C 2T2
      • Research Site
    • Toronto, Ontario, Canada, M9N 1N8
      • Research Site
    • Whitby, Ontario, Canada, L1N 5T2
      • Research Site
  • Quebec
    • Gatineau, Quebec, Canada, J8Y 6S8
      • Research Site
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Research Site
    • Montreal, Quebec, Canada, H4J 1C5
      • Research Site
    • Montreal, Quebec, Canada, H1T 2M4
      • Research Site
• Colombia
  • Cali, Colombia, 760032
    • Research Site
  • Chia, Colombia, 250008
    • Research Site
  • Medellin, Colombia, 5001000
    • Research Site
  • Zipaquira, Colombia, 250258
    • Research Site
• Czechia
  • Brno, Czechia, 625 00
    • Research Site
  • Havlickuv Brod, Czechia, 580 22
    • Research Site
  • Ivancice, Czechia, 664 91
    • Research Site
  • Praha, Czechia, 190 61
    • Research Site
  • Rychnov nad Kneznou, Czechia, 516 01
    • Research Site
  • Slany, Czechia, 274 01
    • Research Site
  • Slavkov u Brna, Czechia
    • Research Site
  • Sumperk, Czechia, 787 01
    • Research Site
  • Usti nad Labem, Czechia, 401 13
    • Research Site
  • Usti nad Orlici, Czechia, 562 18
    • Research Site
• Germany
  • Berlin, Germany, 10117
    • Research Site
  • Cloppenburg, Germany, 49661
    • Research Site
  • Köln, Germany, 50937
    • Research Site
• Hungary
  • Ajka, Hungary, 8400
    • Research Site
  • Budapest, Hungary, 1134
    • Research Site
  • Budapest, Hungary, 1096
    • Research Site
  • Gyula, Hungary, 5700
    • Research Site
  • Hatvan, Hungary, 3000
    • Research Site
  • Kecskemét, Hungary, 6000
    • Research Site
  • Nyíregyháza, Hungary, 4400
    • Research Site
  • Polgár, Hungary, 4090
    • Research Site
  • Pécs, Hungary, 7623
    • Research Site
  • Salgótarján, Hungary, 3100
    • Research Site
  • Siófok, Hungary, 8600
    • Research Site
  • Tatabánya, Hungary, 2800
    • Research Site
  • Velence, Hungary, 2481
    • Research Site
• India
  • Ahmedabad, India, 380016
    • Research Site
  • Bangalore, India, 560068
    • Research Site
  • Bangalore, India, 560052
    • Research Site
  • Bangalore, India, 560070
    • Research Site
  • Chennai, India, 600006
    • Research Site
  • Ghaziabad NCR, India, 201012
    • Research Site
  • Hyderabad, India, 500018
    • Research Site
  • Hyderabad, India, 500072
    • Research Site
  • Kolkatta, India, 700027
    • Research Site
  • Lucknow, India, 226003
    • Research Site
  • Maharashtra, India, 411013
    • Research Site
  • Mumbai, India, 400008
    • Research Site
  • Mysore, India, 570004
    • Research Site
  • Nagpur, India, 420012
    • Research Site
  • Nagpur, India, 440003
    • Research Site
  • Nagpur, India, 440012
    • Research Site
  • New Delhi, India, 110017
    • Research Site
  • New Delhi, India, 110060
    • Research Site
  • Pune, India, 411001
    • Research Site
  • Vijayawada, India, 520 008
    • Research Site
  • Vijayawada, India, 522002
    • Research Site
  • Vishakhapatnam, India, 530002
    • Research Site
• Korea, Republic of
  • Ansan-si, Korea, Republic of, 15355
    • Research Site
  • Busan, Korea, Republic of, 49241
    • Research Site
  • Daegu, Korea, Republic of, 42415
    • Research Site
  • Daejeon, Korea, Republic of, 35015
    • Research Site
  • Goyang-si, Korea, Republic of, 10380
    • Research Site
  • Goyang-si, Korea, Republic of, 10444
    • Research Site
  • Incheon, Korea, Republic of, 403-720
    • Research Site
  • Seongnam-si, Korea, Republic of, 13620
    • Research Site
  • Seoul, Korea, Republic of, 06273
    • Research Site
  • Seoul, Korea, Republic of, 03312
    • Research Site
  • Seoul, Korea, Republic of, 08308
    • Research Site
  • Seoul, Korea, Republic of, 139-711
    • Research Site
  • Uijeongbu-si, Korea, Republic of, 11765
    • Research Site
• Malaysia
  • George Town, Malaysia, 10990
    • Research Site
  • Kubang Kerian, Malaysia, 16150
    • Research Site
  • Putrajaya, Malaysia, 62250
    • Research Site
  • Taiping, Malaysia, 34000
    • Research Site
• Mexico
  • Aguascalientes, Mexico, 20219
    • Research Site
  • Culiacán, Mexico, 80230
    • Research Site
  • Guadalajara, Mexico, 44670
    • Research Site
  • Guadalajara, Mexico, 44676
    • Research Site
  • Minatitlán, Mexico, 96730
    • Research Site
  • México, Mexico, 06726
    • Research Site
  • Veracruz, Mexico, 91900
    • Research Site
  • Xalapa, Mexico, 91020
    • Research Site
• Peru
  • Bellavista, Peru, CALLAO 2
    • Research Site
  • Ica, Peru
    • Research Site
  • Lima, Peru, LIMA 27
    • Research Site
  • Lima, Peru, 14
    • Research Site
  • Lima, Peru, L17
    • Research Site
  • Lima, Peru, LIMA 01
    • Research Site
  • Lima, Peru, LIMA 1
    • Research Site
  • Lima, Peru, LIMA 31
    • Research Site
  • Trujillo, Peru, 044
    • Research Site
• Philippines
  • Cebu City, Philippines, 6000
    • Research Site
  • Iloilo, Philippines, 5000
    • Research Site
  • Iloilo City, Philippines, 5000
    • Research Site
  • Quezon City, Philippines, 1101
    • Research Site
• Poland
  • Ciechanów, Poland, 06-400
    • Research Site
  • Końskie, Poland, 26-200
    • Research Site
  • Poznań, Poland, 60-355
    • Research Site
  • Sochaczew, Poland, 96-500
    • Research Site
  • Tczew, Poland, 83-110
    • Research Site
  • Łódź, Poland, 90-141
    • Research Site
• Puerto Rico
  • Cidra, Puerto Rico, 00739
    • Research Site
  • Rio Grande, Puerto Rico, 00745
    • Research Site
  • Rio Piedras, Puerto Rico, 00935
    • Research Site
  • San Juan, Puerto Rico, 00909
    • Research Site
  • San Juan, Puerto Rico, 00917
    • Research Site
  • San Juan, Puerto Rico, 00921
    • Research Site
  • San Juan, Puerto Rico, 00927
    • Research Site
  • Toa Baja, Puerto Rico, 00949
    • Research Site
• Romania
  • Arad, Romania, 310017
    • Research Site
  • Bucuresti, Romania, 010731
    • Research Site
  • Bucuresti, Romania, 020475
    • Research Site
  • Targu Mures, Romania, 540000
    • Research Site
  • Timisoara, Romania, 300736
    • Research Site
• Russian Federation
  • Arkhangelsk, Russian Federation, 163001
    • Research Site
  • Barnaul, Russian Federation, 656024
    • Research Site
  • Irkutsk, Russian Federation, 664049
    • Research Site
  • Izhevsk, Russian Federation, 426035
    • Research Site
  • Kemerovo, Russian Federation, 650066
    • Research Site
  • Krasnoyarsk, Russian Federation, 660062
    • Research Site
  • Moscow, Russian Federation, 105229
    • Research Site
  • Moscow, Russian Federation, 109263
    • Research Site
  • Moscow, Russian Federation, 129344
    • Research Site
  • Nizhniy Novgorod, Russian Federation, 603076
    • Research Site
  • Nizhny Novgorod, Russian Federation, 603126
    • Research Site
  • Perm, Russian Federation, 614000
    • Research Site
  • Ryazan, Russian Federation, 390027
    • Research Site
  • Saint Petersburg, Russian Federation, 194354
    • Research Site
  • Saint Petersburg, Russian Federation, 196601
    • Research Site
  • Saint Petersburg, Russian Federation, 191015
    • Research Site
  • Ufa, Russian Federation, 450000
    • Research Site
  • Ufa, Russian Federation, 450005
    • Research Site
  • Ufa, Russian Federation, 450071
    • Research Site
  • Volgograd, Russian Federation, 404120
    • Research Site
• Slovakia
  • Bratislava, Slovakia, 82606
    • Research Site
  • Bratislava, Slovakia, 831 03
    • Research Site
  • Kosice, Slovakia, 04011
    • Research Site
  • Kralovsky Chlmec, Slovakia, 077 01
    • Research Site
  • Nove Zamky, Slovakia, 940 34
    • Research Site
  • Zvolen, Slovakia, 960 01
    • Research Site
• Spain
  • Almería, Spain, 04009
    • Research Site
  • Málaga, Spain, 29010
    • Research Site
  • Santiago de Compostela, Spain, 15706
    • Research Site
  • Sevilla, Spain, 41013
    • Research Site
  • Valencia, Spain, 46010
    • Research Site
  • Valencia, Spain, 46026
    • Research Site
  • Valencia, Spain, 46017
    • Research Site
• Taiwan
  • Kaohsiung City, Taiwan, 82445
    • Research Site
  • Keelung, Taiwan, 20401
    • Research Site
  • New Taipei, Taiwan, 220
    • Research Site
  • New Taipei, Taiwan, 231
    • Research Site
  • New Taipei, Taiwan, 23561
    • Research Site
  • Taichung, Taiwan, 402
    • Research Site
  • Taipei, Taiwan
    • Research Site
  • Taipei, Taiwan, 0116
    • Research Site
  • Taipei, Taiwan, 10491
    • Research Site
  • TaoYuan, Taiwan, 333
    • Research Site
• Thailand
  • Bangkok, Thailand, 10300
    • Research Site
  • Bangkok, Thailand, 10330
    • Research Site
  • Bangkok, Thailand, 10400
    • Research Site
  • Bangkok, Thailand, 10700
    • Research Site
  • Khon Kaen, Thailand, 40002
    • Research Site
  • Khon Kaen, Thailand, 40000
    • Research Site
• Turkey
  • Adana, Turkey, 01330
    • Research Site
  • Ankara, Turkey, 06230
    • Research Site
  • Ankara, Turkey, 06490
    • Research Site
  • Antalya, Turkey
    • Research Site
  • Istanbul, Turkey, 34098
    • Research Site
  • Istanbul, Turkey, 34093
    • Research Site
  • Izmir, Turkey, 35040
    • Research Site
• Ukraine
  • Chernivtsi, Ukraine, 58002
    • Research Site
  • Dnipro, Ukraine, 49005
    • Research Site
  • Ivano-Frankivsk, Ukraine, 76008
    • Research Site
  • Kharkiv, Ukraine, 61002
    • Research Site
  • Kharkiv, Ukraine, 61039
    • Research Site
  • Kharkiv, Ukraine, 61058
    • Research Site
  • Kharkiv, Ukraine, 61103
    • Research Site
  • Khmelnytsky, Ukraine, 29000
    • Research Site
  • Kirovograd, Ukraine, 25006
    • Research Site
  • Kyiv, Ukraine, 01601
    • Research Site
  • Kyiv, Ukraine, 02125
    • Research Site
  • Kyiv, Ukraine, 04050
    • Research Site
  • Kyiv, Ukraine, 04107
    • Research Site
  • Kyiv, Ukraine, 04114
    • Research Site
  • Lutsk, Ukraine, 43005
    • Research Site
  • Lviv, Ukraine, 79010
    • Research Site
  • Odesa, Ukraine, 65009
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  • Rivne, Ukraine, 33027
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  • Vinnytsia, Ukraine, 21029
    • Research Site
  • Vinnytsia, Ukraine, 21018
    • Research Site
  • Zaporizhzhya, Ukraine, 69001
    • Research Site
  • Zaporizhzhya, Ukraine, 69068
    • Research Site
  • Zaporizhzhya, Ukraine, 69118
    • Research Site
  • Zaporizhzhya, Ukraine, 69600
    • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Research Site
    • Huntsville, Alabama, United States, 35805
      • Research Site
  • Arizona
    • Phoenix, Arizona, United States, 85027
      • Research Site
  • California
    • Bakersfield, California, United States, 93309
      • Research Site
    • El Centro, California, United States, 92243
      • Research Site
    • Escondido, California, United States, 92025
      • Research Site
    • Glendale, California, United States, 91204
      • Research Site
    • Long Beach, California, United States, 90806
      • Research Site
    • Long Beach, California, United States, 90807
      • Research Site
    • Los Angeles, California, United States, 90022
      • Research Site
    • Los Angeles, California, United States, 90095
      • Research Site
    • Lynwood, California, United States, 90262
      • Research Site
    • National City, California, United States, 91950
      • Research Site
    • Northridge, California, United States, 91324
      • Research Site
    • Orange, California, United States, 92868
      • Research Site
    • Sacramento, California, United States, 95825
      • Research Site
    • Sacramento, California, United States, 95831
      • Research Site
    • San Diego, California, United States, 92103
      • Research Site
    • San Dimas, California, United States, 91773
      • Research Site
    • San Francisco, California, United States, 94110
      • Research Site
    • San Luis Obispo, California, United States, 93401
      • Research Site
    • Upland, California, United States, 91786
      • Research Site
  • Colorado
    • Arvada, Colorado, United States, 80002
      • Research Site
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Research Site
  • Florida
    • Aventura, Florida, United States, 33180
      • Research Site
    • Coral Gables, Florida, United States, 33134
      • Research Site
    • Coral Springs, Florida, United States, 33071
      • Research Site
    • Edgewater, Florida, United States, 32132
      • Research Site
    • Hollywood, Florida, United States, 33021
      • Research Site
    • Kissimmee, Florida, United States, 34741
      • Research Site
    • Lauderdale Lakes, Florida, United States, 33313
      • Research Site
    • Miami, Florida, United States, 33126
      • Research Site
    • Miami, Florida, United States, 33173
      • Research Site
    • Miami, Florida, United States, 33165
      • Research Site
    • Miami, Florida, United States, 33133
      • Research Site
    • Miami, Florida, United States, 33150
      • Research Site
    • Miami, Florida, United States, 33130
      • Research Site
    • Miami, Florida, United States, 33145
      • Research Site
    • Miami, Florida, United States, 33169
      • Research Site
    • Port Charlotte, Florida, United States, 33952
      • Research Site
    • Tampa, Florida, United States, 33607
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Research Site
    • Columbus, Georgia, United States, 31904
      • Research Site
    • Columbus, Georgia, United States, 31901
      • Research Site
  • Illinois
    • Joliet, Illinois, United States, 60435
      • Research Site
    • La Grange, Illinois, United States, 60525
      • Research Site
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Research Site
    • Shreveport, Louisiana, United States, 71101
      • Research Site
  • Maine
    • Rockport, Maine, United States, 04856
      • Research Site
  • Maryland
    • Greenbelt, Maryland, United States, 20770
      • Research Site
    • Rockville, Maryland, United States, 20852
      • Research Site
  • Michigan
    • Port Huron, Michigan, United States, 48060
      • Research Site
  • Mississippi
    • Gulfport, Mississippi, United States, 39501
      • Research Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States, 68124
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Research Site
    • Las Vegas, Nevada, United States, 89128
      • Research Site
    • Reno, Nevada, United States, 89511
      • Research Site
  • New Hampshire
    • Rochester, New Hampshire, United States, 03867
      • Research Site
  • New York
    • Flushing, New York, United States, 11355
      • Research Site
    • Great Neck, New York, United States, 11021
      • Research Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Research Site
    • High Point, North Carolina, United States, 27262
      • Research Site
    • Jacksonville, North Carolina, United States, 28546
      • Research Site
    • New Bern, North Carolina, United States, 28562
      • Research Site
    • Wilmington, North Carolina, United States, 28401
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45206
      • Research Site
    • Cincinnati, Ohio, United States, 45220
      • Research Site
    • Columbus, Ohio, United States, 43215
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73116
      • Research Site
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Research Site
    • Lansdale, Pennsylvania, United States, 19446
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19104
      • Research Site
    • Uniontown, Pennsylvania, United States, 15401
      • Research Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02908
      • Research Site
    • Providence, Rhode Island, United States, 02915
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  • South Carolina
    • Columbia, South Carolina, United States, 29203
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  • Tennessee
    • Knoxville, Tennessee, United States, 37923
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  • Texas
    • Corpus Christi, Texas, United States, 78404
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    • Cypress, Texas, United States, 77429
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    • Dallas, Texas, United States, 75231
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    • Houston, Texas, United States, 77074
      • Research Site
    • Houston, Texas, United States, 77090
      • Research Site
    • Houston, Texas, United States, 77004
      • Research Site
    • Houston, Texas, United States, 77024
      • Research Site
    • Houston, Texas, United States, 77084
      • Research Site
    • Houston, Texas, United States, 77099
      • Research Site
    • Lufkin, Texas, United States, 75904
      • Research Site
    • San Antonio, Texas, United States, 78229
      • Research Site
    • San Antonio, Texas, United States, 78212
      • Research Site
    • San Antonio, Texas, United States, 78258
      • Research Site
    • San Antonio, Texas, United States, 78207
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  • Utah
    • Saint George, Utah, United States, 84790
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    • Salt Lake City, Utah, United States, 84115
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  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Research Site
    • Salem, Virginia, United States, 24153
      • Research Site
    • Woodbridge, Virginia, United States, 22191
      • Research Site
• Vietnam
  • Can Tho, Vietnam, 900000
    • Research Site
  • Hanoi, Vietnam, 100000
    • Research Site
  • Ho Chi Minh City, Vietnam, 700000
    • Research Site
  • Hochiminh, Vietnam, 550000
    • Research Site
  • Hochiminh, Vietnam, 700000
    • Research Site
  • Hue, Vietnam, 530000
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures.
2. Age ≥18 years at screening visit 1
3. eGFR <60 mL/min/1.73 m2, (calculated by central lab) corresponding to stage 3, 4 or 5CKD according to the Kidney Disease Outcomes Quality Initiative (KDOQI), not receiving dialysis
4. Mean of 2 most recent central laboratory Hb values during the screening period, obtained at least 7 days apart, must be <10.0 g/dL
5. Ferritin ≥50 ng/mL at randomization (obtained from screening visit)
6. TSAT ≥15 % at randomization (obtained from screening visit)
7. Serum folate level ≥ lower limit of normal (LLN) at randomization (obtained from screening visit)
8. Serum vitamin B12 level ≥LLN at randomization (obtained from screening visit)
9. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN) and total bilirubin (Tbili) ≤1.5 x ULN at randomization (obtained from screening visit)
10. Body weight 45 to 160 kg

Exclusion Criteria:

1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
2. Previous randomization in the present study
3. Any erythropoietin analogue treatment within 6 weeks of randomization
4. New York Heart Association Class III or IV congestive heart failure at enrollment
5. Myocardial infarction (MI), acute coronary syndrome, stroke, seizure or a thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization
6. History of chronic liver disease (e.g., chronic infectious hepatitis, chronic auto- immune liver disease, cirrhosis or fibrosis of the liver)
7. Known hereditary hematologic disease such as thalassemia, sickle cell anemia, a history of pure red cell aplasia or other known causes for anemia other than CKD
8. Known and untreated retinal vein occlusion or known and untreated proliferative diabetic retinopathy (risk for retinal vein thrombosis)
9. Diagnosis or suspicion (e.g. complex kidney cyst of Bosniak Category IIF, III or IV) of renal cell carcinoma on renal ultrasound (or other imaging procedure e.g. CT scan or MRI) conducted at screening or within 12 weeks prior to randomization
10. Systolic BP ≥160 mmHg or diastolic BP ≥95 mmHg (confirmed by repeated measurement), within 2 weeks prior to randomization. Patients may be rescreened once BP controlled
11. History of prostate cancer, breast cancer or any other malignancy, except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps
12. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibody (anti-HCV Ab)
13. Chronic inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematosus (SLE), ankylosing spondylitis, psoriatic arthritis or inflammatory bowel disease that is determined to be the principal cause of anemia
14. Known hemosiderosis, hemochromatosis or hypercoagulable condition
15. Any prior organ transplant or a scheduled organ transplantation date
16. Any red blood cell transfusion (RBC) during the screening period
17. Any current condition leading to active significant blood loss
18. Any treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)
19. Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within at least 1 month of the first administration of IP in this study. (Note: patients consented and screened, but not randomized in this study or a previous study are not excluded)
20. History of alcohol or drug abuse within 2 years prior to randomization
21. Females of childbearing potential, unless using contraception as detailed in the protocol or sexual abstinence
22. Pregnant or breastfeeding females
23. Known allergy to the investigational product or any of its ingredients
24. Any medical condition, including active, clinically significant infection, that in the opinion of the investigator or Sponsor may pose a safety risk to a patient in this study, which may confound efficacy or safety assessment or may interfere with study participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; The initial study drug dose is 70 mg three times a week (TIW). The dose is subsequently adjusted to achieve and maintain Hb 11±1 g/dL.
Experimental: Roxadustat	Drug: Roxadustat; The initial study drug dose is 70 mg three times a week (TIW). The dose is subsequently adjusted to achieve and maintain Hb 11±1 g/dL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52	Baseline Hb was defined as the mean of the last 3 central laboratory Hb values from the screening and randomization visits. Mean change in Hb from baseline to mean value from Week 28 to Week 52 was analyzed using a missing at random (MAR) based multiple imputation analysis of covariance (ANCOVA) model with baseline Hb, baseline estimated glomerular filtration rate (eGFR), cardiovascular (CV) history, geographic region and treatment group as fixed effect covariates. The adjusted least squares (LS) mean estimates of change from baseline to mean during Week 28 to Week 52 are presented.	Baseline (Day 1, Week 0) and Week 28 to Week 52.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Hb Response During the First 24 Weeks of Treatment	Hb response was defined as: Hb ≥ 11.0 g/dL and Hb increase from baseline by ≥ 1.0 g/dL for participants with baseline Hb > 8.0 g/dL; or; Hb increase from baseline by ≥ 2.0 g/dL, for participants with baseline Hb ≤ 8.0 g/dL at 2 consecutive visits (with available data) separated at least 5 days during the first 24 weeks of treatment without having received rescue therapy (red blood cell [RBC] transfusion, erythropoietin analogue, or intravenous [IV] iron) prior to Hb response. The percentage of participants with an Hb response during the first 24 weeks of treatment is presented.	Baseline (Day 1, Week 0) up to Week 24.
Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 in Participants With Baseline High Sensitivity C-Reactive Protein (hsCRP) Greater Than the Upper Limit of Normal (ULN)	Baseline hsCRP was quantified from stored biomarker samples obtained at randomization. Baseline Hb was defined as the mean of the last 3 central laboratory Hb values from the screening and randomization visits. Mean change in Hb from baseline to mean value during Week 28 to Week 52 was analyzed using a MAR based multiple imputation ANCOVA model with baseline Hb, baseline eGFR, CV history, geographic region and treatment group as fixed effect covariates. The adjusted LS mean estimates of change from baseline in participants with baseline hsCRP >ULN to mean during Week 28 to Week 52 are presented.	Baseline (Day 1, Week 0) and Week 28 to Week 52.
Proportion of Total Time of Interpolated Hb Values Greater Than or Equal To 10 g/dL From Week 28 to Week 52	Proportion of total time of interpolated Hb values ≥10 g/dL was calculated as the time the linearly interpolated curve between measurements ≥10 g/dL divided by the time between measurements from Week 28 to Week 52. Proportion of total time was analyzed using an ANCOVA model with baseline Hb and baseline eGFR as covariates, and CV history, geographic region and treatment group as fixed effects. The adjusted LS mean estimates of change from Week 28 to Week 52 are presented.	Week 28 up to Week 52.
Proportion of Total Time of Interpolated Hb Values Within the Interval of 10 to 12 g/dL From Week 28 to Week 52	Proportion of total time of interpolated Hb values within the interval of 10 to 12 g/dL was calculated as the time the linearly interpolated curve between measurements were within 10 to 12 g/dL divided by the time between measurements from Week 28 to Week 52. Proportion of total time was analyzed using an ANCOVA model with baseline Hb and baseline eGFR as covariates, and CV history, geographic region and treatment group as fixed effects. The adjusted LS mean estimates of change from Week 28 to Week 52 are presented.	Week 28 up to Week 52.
Mean Change in Low-Density Lipoprotein (LDL) Cholesterol From Baseline to Week 24	Baseline LDL was defined as the last result obtained prior to randomization. Mean changes in LDL cholesterol from baseline to Week 24 was analyzed using an ANCOVA model with baseline LDL, baseline Hb and baseline eGFR as covariates, and CV history, geographic region and treatment group as fixed effects. The adjusted LS mean estimates of change from baseline to Week 24 are presented.	Baseline (Day 1, Week 0) and Week 24
Time-To-First Instance of Receiving IV Iron, RBC Transfusion or Erythropoietin Analogue as Rescue Therapy	Time-to-first rescue therapy (IV iron, RBC transfusion or erythropoietin analogue) was calculated as (date of first rescue therapy, or date of censoring if no rescue therapy was taken) minus (date of first dose of IP) +1. Event rate was calculated as (number of participants with event) divided by (the total number of days at risk for event across all participants in given group divided by 365.25) multiplied by 100. The event rate is presented for participants with events.	Baseline (Day1, Week 0) up to End of Study (EOS) visit (4 weeks after the treatment period) (or up to date of first rescue therapy), with treatment duration up to 4 years.
Time-To-First Instance of Receiving a RBC Transfusion As Rescue Therapy	Time-to-first RBC rescue therapy was calculated as (date of first RBC rescue therapy, or date of censoring if no rescue therapy was taken) minus (date of first dose of IP) +1. Event rate was calculated as (number of participants with event) divided by (the total number of days at risk for event across all participants in given group divided by 365.25) multiplied by 100. The event rate is presented for participants with events.	Baseline (Day1, Week 0) up to EOS visit (4 weeks after the treatment period) (or up to date of first RBC rescue therapy), with treatment duration up to 4 years.
Mean Change From Baseline in Short Form 36 (SF-36) Vitality Sub-Score From Week 12 to Week 28	SF-36 is a Quality of Life (QoL) scale comprising 8 domains of health status: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health. Each domain score is on a scale from 0-100 (worst health possible to best health possible); higher scores indicate better health status. Mean change in SF-36 Vitality sub-score from baseline to mean from Week 12 to Week 28 was analyzed using a mixed model for repeated measures (MMRM) with terms for baseline score, treatment group, baseline Hb, baseline eGFR, CV history, geographic region, visit and treatment-by-visit interaction as fixed effects and participant as random effect. The adjusted LS mean estimates of change from baseline to mean score from Week 12 to Week 28 are presented.	Baseline (Day 1, Week 0) and Week 12 to Week 28.
Annual Rate of eGFR Change From Baseline Prior to the Initiation of Dialysis or Kidney Transplant	Baseline eGFR was defined as the mean of all available central laboratory values prior to or at randomization. Rate of change in eGFR from baseline during the entire treatment period (in millilitres/minute/1.73 meters squared/years [mL/min/1.73m^2/years]) was estimated using a random effects model using all post-baseline eGFR values prior to initiation of dialysis/transplant. Baseline eGFR, baseline Hb, geographic region, CV history, treatment group and post-baseline eGFR measurement time were used as fixed effects and participant and time (years) as random effects, ie, random intercept and slope.	Baseline (Day1, Week 0) up to EOS visit (4 weeks after the treatment period), with treatment duration up to 4 years.
Mean Change From Baseline in SF-36 Physical Functioning Sub-Score From Week 12 to Week 28	SF-36 is a QoL scale comprising 8 domains of health status: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health. Each domain score is on a scale from 0-100 (worst health possible to best health possible); higher scores indicate better health status. Mean change in SF-36 Physical Functioning sub-score from baseline to mean from Week 12 to Week 28 was analyzed using a MMRM with terms for baseline score, treatment group, baseline Hb, baseline eGFR, CV history, geographic region, visit and treatment-by-visit interaction as fixed effects and participant as random effect. The adjusted LS mean estimates of change from baseline to mean score from Week 12 to Week 28 are presented.	Baseline (Day 1, Week 0) and Week 12 to Week 28.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: FibroGen
• Investigators: Study Director: Mark Houser, MD, AZ R&D Gaithersburg, USA

Publications and helpful links

General Publications

• 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.
• Provenzano R, Szczech L, Leong R, Saikali KG, Zhong M, Lee TT, Little DJ, Houser MT, Frison L, Houghton J, Neff TB. Efficacy and Cardiovascular Safety of Roxadustat for Treatment of Anemia in Patients with Non-Dialysis-Dependent CKD: Pooled Results of Three Randomized Clinical Trials. Clin J Am Soc Nephrol. 2021 Aug;16(8):1190-1200. doi: 10.2215/CJN.16191020.
• Fishbane S, El-Shahawy MA, Pecoits-Filho R, Van BP, Houser MT, Frison L, Little DJ, Guzman NJ, Pergola PE. Roxadustat for Treating Anemia in Patients with CKD Not on Dialysis: Results from a Randomized Phase 3 Study. J Am Soc Nephrol. 2021 Mar;32(3):737-755. doi: 10.1681/ASN.2020081150. Epub 2021 Feb 10.

Helpful Links

• Related Info
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Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2014
• Primary Completion (Actual): October 4, 2018
• Study Completion (Actual): October 4, 2018

Study Registration Dates

• First Submitted: June 24, 2014
• First Submitted That Met QC Criteria: June 24, 2014
• First Posted (Estimate): June 25, 2014

Study Record Updates

• Last Update Posted (Actual): December 16, 2019
• Last Update Submitted That Met QC Criteria: November 27, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Renal,; CKD,; Roxadustat,; anemia,; non-dialysis
• Additional Relevant MeSH Terms: Urologic Diseases; Hematologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Anemia
• Other Study ID Numbers: D5740C00001