Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis
NCT ID: NCT01887600
Last Updated: 2024-11-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
594 participants
INTERVENTIONAL
2013-09-03
2017-11-01
Brief Summary
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Detailed Description
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* Screening period: up to 6 weeks
* Treatment period: minimum 52 weeks (primary treatment period) up to a maximum of 104 weeks (extended treatment period)
* Post-Treatment Follow-Up period: 4 weeks
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Roxadustat
Participants received roxadustat according to the tiered weight-based approach, with starting doses of 70 mg given thrice weekly (TIW) to participants weighing up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg. Dose-titration was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received roxadustat for at least 52 weeks up to a maximum of 104 weeks.
Roxadustat
Roxadustat was administered initially according to the tiered weight-based dosing, where participants with weight from ≥ 45 to ≤ 70 kg received 70 mg and participants with \> 70 to ≤ 160 kg received 100 mg of roxadustat. Dose-titration based upon regular measurement of Hb levels was performed until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL.
Placebo
Participants received matching placebo according to the tiered weight-based approach, with starting doses of 70 mg given thrice weekly (TIW) to participants weighing up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg. Dose-titration was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received matching placebo for at least 52 weeks up to a maximum of 104 weeks.
Placebo
Placebo was administered initially according to the tiered weight-based dosing, where participants with weight from ≥ 45 to ≤ 70 kg received 70 mg and participants with \> 70 to ≤ 160 kg received 100 mg of roxadustat. Dose-titration based upon regular measurement of Hb levels was performed until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL.
Interventions
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Roxadustat
Roxadustat was administered initially according to the tiered weight-based dosing, where participants with weight from ≥ 45 to ≤ 70 kg received 70 mg and participants with \> 70 to ≤ 160 kg received 100 mg of roxadustat. Dose-titration based upon regular measurement of Hb levels was performed until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL.
Placebo
Placebo was administered initially according to the tiered weight-based dosing, where participants with weight from ≥ 45 to ≤ 70 kg received 70 mg and participants with \> 70 to ≤ 160 kg received 100 mg of roxadustat. Dose-titration based upon regular measurement of Hb levels was performed until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The mean of the Participant's three most recent Hb values during the Screening period, obtained at least 4 days apart, must be less than or equal to 10.0 g/dL, with a difference of less than or equal to 1.0 g/dL between the highest and the lowest values. The last Hb value must be within 10 days prior to randomization.
* Participant has a ferritin level greater than or equal to 30 ng/mL (greater than or equal to 67.4 pmol/L) at screening.
* Participant has a transferrin saturation (TSAT) level greater than or equal to 5% at screening.
* Participant has a serum folate level greater than or equal to lower limit of normal at screening.
* Participant has a serum vitamin B12 level greater than or equal to lower limit of normal at screening.
* Participant's alanine aminotransferase (ALT), aspartate aminotransferase (AST) levels are less than or equal to 3 x upper limit of normal (ULN), and total bilirubin (TBL) is less than or equal to 1.5 x ULN.
* Participant's body weight is 45.0 kg up to a maximum of 160.0 kg.
Exclusion Criteria
* Participant has had more than one dose of IV iron within 12 weeks prior to randomization.
* Participant has received a RBC transfusion within 8 weeks prior to randomization.
* Participant has a known history of myelodysplastic syndrome or multiple myeloma.
* Participant has a known hereditary hematologic disease such as thalassemia or sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD.
* Participant has a known hemosiderosis, hemochromatosis, coagulation disorder, or hypercoagulable condition.
* Participant has chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosus, rheumatoid arthritis, celiac disease) even if it is currently in remission.
* Participant is anticipated to have elective surgery that is expected to lead to significant blood loss or anticipated elective coronary revascularization.
* Participant has active or chronic gastrointestinal bleeding.
* Participant has received any prior treatment with roxadustat or a hypoxia-inducible factor Prolyl Hydroxylase Inhibitor (HIF-PHI).
* Participant has been treated with iron-chelating agents within 4 weeks prior to randomization.
* Participant has a history of chronic liver disease (e.g., cirrhosis or fibrosis of the liver)
* Participant has a known New York Heart Association Class III or Intravenous (IV) congestive heart failure.
* Participant has had a myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (e.g., pulmonary embolism) within 12 weeks prior to randomization.
* Uncontrolled hypertension or two or more blood pressure (BP) values of systolic BP (SBP) greater than or equal to 160 mmHg or diastolic BP (DBP) greater than or equal to 95 mmHg confirmed by repeat measurement within 2 weeks prior to randomization.
* Participant has a diagnosis or suspicion (e.g., complex kidney cyst of Bosniak Category 2F or higher) of renal cell carcinoma on renal ultrasound within 12 weeks prior to randomization.
* Participant has a history of malignancy, except the following: cancers determined to be cured or in remission for greater than or equal to 5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps.
* Participant is positive for any of the following: Human Immunodeficiency Virus (HIV); hepatitis B surface antigen (HBsAg); or anti-hepatitis C virus antibody (anti-HCV Ab).
* Participant has an active clinically significant infection manifested by White Blood Count (WBC) \> ULN, and/or fever, in conjunction with clinical signs or symptoms of infection within one week prior to randomization.
* Participant has a known untreated proliferative diabetic retinopathy, diabetic macular edema, macular degeneration and retinal vein occlusion.
* Participant has had any prior organ transplant (that has not been explanted) or a scheduled organ transplantation.
* Participant has participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives or limit set by national law, whichever is longer, prior to the initiation of Screening.
* Participant has an anticipated use of dapsone in any dose amount or chronic use of acetaminophen (paracetamol) \> 2.0 g/day during the treatment or follow-up period of the study.
* Participant has a history of alcohol or drug abuse within 2 years prior to randomization.
18 Years
ALL
No
Sponsors
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FibroGen
INDUSTRY
Astellas Pharma Europe B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_CHAIR
Astellas Pharma Europe B.V.
Locations
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Site BY37503
Brest, , Belarus
Site BY37501
Grodno, , Belarus
Site BY37504
Homyel, , Belarus
Site BY37506
Minsk, , Belarus
Site BY37507
Minsk, , Belarus
Site BY37505
Minsk, , Belarus
Site BY37502
Vitebsk, , Belarus
Site BE32004
Brussels, Flemish Brabant, Belgium
Site BE32002
Antwerp, , Belgium
Site BE32012
Baudour, , Belgium
Site BE32017
Bonheiden, , Belgium
Site BE32014
Ieper, , Belgium
Site BE32013
Liège, , Belgium
Site BG35923
Pazardzhik, , Bulgaria
Site BG35906
Sofia, , Bulgaria
Site BG35908
Sofia, , Bulgaria
Site BG35910
Sofia, , Bulgaria
Site BG35907
Stara Zagora, , Bulgaria
Site BG35916
Varna, , Bulgaria
Site BG35903
Veliko Tarnovo, , Bulgaria
Site CO57007
Barranquilla, , Colombia
Site CO57008
Barranquilla, , Colombia
Site CO57002
Pereira, , Colombia
Site DO17101
La Fe Santo Domingo, , Dominican Republic
Site DO17102
Santiago de los Caballeros, , Dominican Republic
Site DO17104
Santo Domingo, , Dominican Republic
Site DO17103
Santo Domingo, , Dominican Republic
Site EE37201
Tallinn, , Estonia
Site GE99503
Tbilisi, , Georgia
Site GE99504
Tbilisi, , Georgia
Site GE99502
Tbilisi, , Georgia
Site GR30003
Heraklion, , Greece
Site GR30002
Pátrai, , Greece
Site GR30001
Thessaloniki, , Greece
Site GT50209
Chiquimula, , Guatemala
Site GT50205
Guatemala City, , Guatemala
Site GT50206
Guatemala City, , Guatemala
Site GT50203
Guatemala City, , Guatemala
Site GT50202
Guatemala City, , Guatemala
Site GT50208
Guatemala City, , Guatemala
Site GT50207
Guatemala City, , Guatemala
Site GT50201
Guatemala City, , Guatemala
Site HU36029
Budapest, , Hungary
Site HU36025
Győr, , Hungary
Site HU36026
Kaposvár, , Hungary
Site HU36027
Kistarcsa, , Hungary
Site HU36008
Pécs, , Hungary
Site HU36028
Szent, , Hungary
Site HU36003
Zalsaegerszeg, , Hungary
Site IT39001
Bari, , Italy
Site IT39008
Lecco, , Italy
Site IT39006
Milan, , Italy
Site IT39037
Modena, , Italy
Site IT39036
Pavia, , Italy
Site PA50703
Colón, , Panama
Site PA50701
Panama City, , Panama
Site PE51001
Iquitos, , Peru
Site PE51002
Trujillo, , Peru
Site PL48001
Krakow, Malopolska, Poland
Site PL48002
Katowice, , Poland
Site PL48012
Lodz, , Poland
Site PL48008
Lodz, , Poland
Site PL48057
Nowy Tomyśl, , Poland
Site PL48013
Szczecin, , Poland
Site PL48007
Tarnów, , Poland
Site PL48005
Warsaw, , Poland
Site PL48004
Warsaw, , Poland
Site PL48006
Wroclaw, , Poland
Site PL48014
Zamość, , Poland
Site RO40005
Timișoara, Timiș County, Romania
Site RO40001
Brasov, , Romania
Site RO40021
Bucharest, , Romania
Site RO40012
Bucharest, , Romania
Site RO40003
Bucharest, , Romania
Site RO40004
Oradea, , Romania
Site RU70024
Chelyabinsk, , Russia
Site RU70054
Irkutsk, , Russia
Site RU70008
Kaluga, , Russia
Site RU70051
Moscow, , Russia
Site RU70007
Moscow, , Russia
Site RU70005
Moscow, , Russia
Site RU70048
Moscow, , Russia
Site RU70047
Moscow, , Russia
Site RU70003
Nizhny Novgorod, , Russia
Site RU70004
Omsk, , Russia
Site RU70043
Petrozavodsk, , Russia
Site RU70014
Rostov-on-Don, , Russia
Site RU70022
Saint Petersburg, , Russia
Site RU70045
Saint Petersburg, , Russia
Site RU70011
Saint Petersburg, , Russia
Site RU70002
Saint Petersburg, , Russia
Site RU70060
Saratov, , Russia
Site RU70006
Smolensk, , Russia
Site RU70057
Yaroslavl, , Russia
Site RU70001
Yaroslavl, , Russia
Site RS38102
Belgrade, , Serbia
Site RS38104
Belgrade, , Serbia
Site RS38105
Belgrade, , Serbia
Site RS38103
Belgrade, , Serbia
Site RS38117
Kruševac, , Serbia
Site RS38101
Niš, , Serbia
Site RS38116
Zrenjanin, , Serbia
Site ZA27001
Observatory, Cape Town, South Africa
Site ZA27004
Bloemfontein, Free State, South Africa
Site ZA27002
Durban, KwaZulu-Natal, South Africa
Site ZA27008
Durban, , South Africa
Site ZA27006
Parow, , South Africa
Site ZA27007
Port Elizabeth, , South Africa
Site ES34010
Alcorcón, Madrid, Spain
Site ES34011
Galdakao, Vizcaya, Spain
Site ES34002
Badalona-Barcelona, , Spain
Site ES34003
Barcelona, , Spain
Site ES34006
Barcelona, , Spain
Site ES34007
Ciudad Real, , Spain
Site TR90003
Ankara, , Turkey (Türkiye)
Site TR90016
Edirne, , Turkey (Türkiye)
Site TR90024
Kocaeli, , Turkey (Türkiye)
Site TR90020
Malatya, , Turkey (Türkiye)
Site UA38009
Lviv, Lvivska, Ukraine
Site UA38021
Cherkasy, , Ukraine
Site UA38003
Chernivtsi, , Ukraine
Site UA38006
Dnipro, , Ukraine
Site UA38016
Ivano-Frankivsk, , Ukraine
Site UA38011
Kharkiv, , Ukraine
Site UA38015
Kherson, , Ukraine
Site UA38010
Kyiv, , Ukraine
Site UA38012
Kyiv, , Ukraine
Site UA38017
Kyiv, , Ukraine
Site UA38007
Mykolaiv, , Ukraine
Site UA38008
Odesa, , Ukraine
Site UA38019
Odesa, , Ukraine
Site UA38001
Ternopil, , Ukraine
Site UA38018
Uzhhorod, , Ukraine
Site UA38002
Zaporizhzhya, , Ukraine
Site GB44008
Cambridge, , United Kingdom
Site GB44001
Swansea, , United Kingdom
Site GB44005
Welwyn Garden City, , United Kingdom
Site GB44004
Westcliff-on-Sea, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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2012-005180-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1517-CL-0608
Identifier Type: -
Identifier Source: org_study_id
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