Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis
NCT ID: NCT02278341
Last Updated: 2024-11-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
838 participants
INTERVENTIONAL
2014-11-21
2018-07-06
Brief Summary
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Detailed Description
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* Screening Period: up to 6 weeks
* Treatment Period: a minimum of 52 weeks up to a maximum of 104 weeks
* Follow-up Period: 4 weeks
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Roxadustat
Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
Roxadustat
Participants received initial dose of roxadustat orally as a tablet in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
Iron
Oral iron treatment was recommended for supplementation to support erythropoiesis and as first-line treatment for iron deficiency, unless participant was intolerant to this treatment. For participants receiving roxadustat the recommended daily dose was 200 mg of elemental iron. Participants were advised to take roxadustat at least 1 hour before or 1 hour after oral iron. Intravenous iron supplementation for participants receiving roxadustat was allowed if all of the following criteria were met: The participant's Hb level had not responded adequately to roxadustat following two consecutive dose increases or reached the maximum dose limit, and participant's ferritin was \< 100 ng/mL (\< 220 pmol/L) or TSAT \< 20%, or the participant was intolerant of oral iron therapy. For participants treated with epoetin alfa or darbepoetin alfa, IV iron supplementation was given according to standard of care.
ESA (Erythropoiesis Stimulating Agent) treatment
Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from the epoetin alfa to darbepoetin alfa or vice versa.
Epoetin alfa
Participants received epoetin alfa via intravenous or subcutaneous injection, once a week, twice a week, or three times a week (TIW). Epoetin alfa dosage was adjusted to maintain Hb level within the target range. Dosing of epoetin alfa was per UK SmPC of Eprex®. Participants received IV iron supplementation according to the standard of care.
Darbepoetin alfa
Participants received darbepoetin alfa via intravenous or subcutaneous injection, once a week or once every other week. Darbepoetin alfa dosage was adjusted to maintain Hb level within the target range. Dosing of darbepoetin alfa was per EU SmPC of Aranesp®. Participants received IV iron supplementation according to the standard of care.
Iron
Oral iron treatment was recommended for supplementation to support erythropoiesis and as first-line treatment for iron deficiency, unless participant was intolerant to this treatment. For participants receiving roxadustat the recommended daily dose was 200 mg of elemental iron. Participants were advised to take roxadustat at least 1 hour before or 1 hour after oral iron. Intravenous iron supplementation for participants receiving roxadustat was allowed if all of the following criteria were met: The participant's Hb level had not responded adequately to roxadustat following two consecutive dose increases or reached the maximum dose limit, and participant's ferritin was \< 100 ng/mL (\< 220 pmol/L) or TSAT \< 20%, or the participant was intolerant of oral iron therapy. For participants treated with epoetin alfa or darbepoetin alfa, IV iron supplementation was given according to standard of care.
Interventions
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Roxadustat
Participants received initial dose of roxadustat orally as a tablet in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
Epoetin alfa
Participants received epoetin alfa via intravenous or subcutaneous injection, once a week, twice a week, or three times a week (TIW). Epoetin alfa dosage was adjusted to maintain Hb level within the target range. Dosing of epoetin alfa was per UK SmPC of Eprex®. Participants received IV iron supplementation according to the standard of care.
Darbepoetin alfa
Participants received darbepoetin alfa via intravenous or subcutaneous injection, once a week or once every other week. Darbepoetin alfa dosage was adjusted to maintain Hb level within the target range. Dosing of darbepoetin alfa was per EU SmPC of Aranesp®. Participants received IV iron supplementation according to the standard of care.
Iron
Oral iron treatment was recommended for supplementation to support erythropoiesis and as first-line treatment for iron deficiency, unless participant was intolerant to this treatment. For participants receiving roxadustat the recommended daily dose was 200 mg of elemental iron. Participants were advised to take roxadustat at least 1 hour before or 1 hour after oral iron. Intravenous iron supplementation for participants receiving roxadustat was allowed if all of the following criteria were met: The participant's Hb level had not responded adequately to roxadustat following two consecutive dose increases or reached the maximum dose limit, and participant's ferritin was \< 100 ng/mL (\< 220 pmol/L) or TSAT \< 20%, or the participant was intolerant of oral iron therapy. For participants treated with epoetin alfa or darbepoetin alfa, IV iron supplementation was given according to standard of care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant is on stable hemodialysis (HD), hemodiafiltration (HDF) or peritoneal dialysis (PD) treatment with the same mode of dialysis for ≥4 months prior to randomization.
* Participant is on IV or SC epoetin or IV or SC darbepoetin alfa treatment for ≥8 weeks prior to randomization with stable weekly doses (during 4 weeks prior to randomization).
* Mean of the participant's three most recent Hb values, as measured by central laboratory, during the Screening Period.
* Participant's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≤3 x upper limit of normal (ULN), and total bilirubin (TBL) is ≤1.5 x ULN
Exclusion Criteria
* Participant has received a red blood cell (RBC) transfusion within 8 weeks prior to randomization.
* 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 Chronic Kidney Disease (CKD).
* Participant has had a myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thrombo-embolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization.
* Participant has had uncontrolled hypertension, in the opinion of the investigator, within 2 weeks prior to randomization.
* Participant has a history of malignancy, except for 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.
* Participant has had any prior organ transplant (that has not been explanted), or participant is scheduled for organ transplantation.
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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Study Physician
Role: STUDY_DIRECTOR
Astellas Pharma Europe B.V.
Locations
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Site BE32004
Brussels, Flemish Brabant, Belgium
Site BE32001
Aalst, , Belgium
Site BE32019
Antwerp, , Belgium
Site BE32002
Antwerp, , Belgium
Site BE32012
Baudour, , Belgium
Site BE32017
Bonheiden, , Belgium
Site BE32003
Leuven, , Belgium
Site BE32013
Liège, , Belgium
Site BE32011
Roeselare, , Belgium
Site BG35925
Blagoevgrad, , Bulgaria
Site BG35931
Haskovo, , Bulgaria
Site BG35915
Pleven, , Bulgaria
Site BG35909
Plovdiv, , Bulgaria
Site BG35919
Plovdiv, , Bulgaria
Site BG35920
Rousse, , Bulgaria
Site BG35938
Shumen, , Bulgaria
Site BG35924
Sofia, , Bulgaria
Site BG35906
Sofia, , Bulgaria
Site BG35921
Sofia, , Bulgaria
Site BG35907
Stara Zagora, , Bulgaria
Site BG35916
Varna, , Bulgaria
Site BG35918
Varna, , Bulgaria
Site BG35903
Veliko Tarnovo, , Bulgaria
Site BG35937
Yambol, , Bulgaria
Site HR38509
Zagreb, City of Zagreb, Croatia
Site HR38508
Čakovec, , Croatia
Site HR38505
Karlovac, , Croatia
Site HR38507
Osijek, , Croatia
Site HR38506
Rijeka, , Croatia
Site HR38504
Slavonski Brod, , Croatia
Site HR38501
Zadar, , Croatia
Site CZ42008
Liberec, , Czechia
Site CZ42021
Prague, , Czechia
Site CZ42015
Rakovník, , Czechia
Site FR33005
Amiens, , France
Site FR33010
La Tronche, , France
Site FR33007
Saint Priez En Jarez, , France
Site FR33055
Saint-Ouen, , France
Site FR33056
Valenciennes, , France
Site GE99503
Tbilisi, , Georgia
Site GE99504
Tbilisi, , Georgia
Site GE99508
Tbilisi, , Georgia
Site DE49056
Dormagen, North Rhine-Westphalia, Germany
Site DE49067
Berlin, , Germany
Site DE49073
Cloppenburg, , Germany
Site DE49008
Dresden, , Germany
Site DE49054
Düsseldorf, , Germany
Site DE49020
Frankfurt am Main, , Germany
Site DE49065
Hamburg, , Germany
Site DE49075
Heilbronn, , Germany
Site DE49001
Kaiserslautern, , Germany
Site DE49070
München, , Germany
Site DE49002
Solingen, , Germany
Site DE49071
Villingen-Schwenningen, , Germany
Site HU36033
Baja, , Hungary
Site HU36036
Esztergom, , Hungary
Site HU36031
Győr, , Hungary
Site HU36026
Kaposvár, , Hungary
Site HU36027
Kistarcsa, , Hungary
Site HU36032
Pécs, , Hungary
Site HU36035
Pécs, , Hungary
Site HU36034
Salgótarján, , Hungary
Site HU36004
Szeged, , Hungary
Site HU36046
Székesfehérvár, , Hungary
Site HU36006
Szombathely, , Hungary
Site HU36003
Zalsaegerszeg, , Hungary
Site IT39028
Prato, Frazione Di Galciana, Italy
Site IT39039
Cremona, Lombardy, Italy
Site IT39014
Mestre, Venezia, Italy
Site IT39010
Brescia, , Italy
Site IT39008
Lecco, , Italy
Site IT39006
Milan, , Italy
Site IT39037
Modena, , Italy
Site IT39022
Padua, , Italy
Site IT39036
Pavia, , Italy
Site IT39005
Roma, , Italy
Site IT39035
Torino, , Italy
Site IT39032
Trieste, , Italy
Site PL48002
Katowice, , Poland
Site PL48001
Krakow, , Poland
Site PL48013
Szczecin, , Poland
Site PL48005
Warsaw, , Poland
Site PL48006
Wroclaw, , Poland
Site PL48009
Wroclaw, , Poland
Site PL48014
Zamość, , Poland
Site PT35121
Almada, , Portugal
Site PT35127
Aveiro, , Portugal
Site PT35139
Cascais, , Portugal
Site PT35117
Faro, , Portugal
Site PT35128
Gaeiras, , Portugal
Site PT35114
Leiria, , Portugal
Site PT35102
Porto, , Portugal
Site PT35122
Setúbal, , Portugal
Site RO40018
Bucharest, , Romania
Site RO40003
Bucharest, , Romania
Site RO40015
Bucharest, , Romania
Site RO40019
Bucharest, , Romania
Site RO40004
Oradea, , Romania
Site RU70008
Kaluga, , Russia
Site RU70051
Moscow, , Russia
Site RU70005
Moscow, , Russia
Site RU70003
Nizhny Novgorod, , Russia
Site RU70004
Omsk, , Russia
Site RU70014
Rostov-on-Don, , Russia
Site RU70072
Saint Petersburg, , Russia
Site RU70011
Saint Petersburg, , Russia
Site RU70002
Saint Petersburg, , Russia
Site RU70030
Saint Petersburg, , Russia
Site RU70050
Saint Petersburg, , Russia
Site RU70006
Smolensk, , Russia
Site RU70037
Volgograd, , Russia
Site RU70001
Yaroslavl, , Russia
Site RS38102
Belgrade, , Serbia
Site RS38105
Belgrade, , Serbia
Site RS38120
Belgrade, , Serbia
Site RS38104
Belgrade, , Serbia
Site RS38117
Kruševac, , Serbia
Site RS38101
Niš, , Serbia
Site RS38116
Zrenjanin, , Serbia
Site SK42102
Košice, , Slovakia
Site SK42119
Levice, , Slovakia
Site SK42120
Lučenec, , Slovakia
Site SK42113
Púchov, , Slovakia
Site SK42116
Senica, , Slovakia
Site ES34041
Santiago de Compostela, A Coruna, Spain
Site ES34009
El Ejido, Almeria, Spain
Site ES34010
Alcorcón, Madrid, Spain
Site ES34030
Majadahonda, Madrid, Spain
Site ES34011
Galdakao, Vizcaya, Spain
Site ES34002
Badalona-Barcelona, , Spain
Site ES34008
Barcelona, , Spain
Site ES34006
Barcelona, , Spain
Site ES34017
Jaén, , Spain
Site ES34037
Madrid, , Spain
Site ES34052
Valencia, , Spain
Site GB44087
Brighton, EastSussex, United Kingdom
Site GB44011
Canterbury, Kent, United Kingdom
Site GB44080
Stoke-on-Trent, Staffordshire, United Kingdom
Site GB44008
Cambridge, , United Kingdom
Site GB44010
Hull, , United Kingdom
Site GB44081
Leicester, , United Kingdom
Site GB44079
Liverpool, , United Kingdom
Site GB44001
Swansea, , United Kingdom
Countries
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References
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Hamano T, Yamaguchi Y, Goto K, Martin S, Jiletcovici A, Dellanna F, Akizawa T, Barratt J. Risk Factors for Thromboembolic Events in Patients With Dialysis-Dependent CKD: Pooled Analysis of Four Global Roxadustat Phase 3 Trials. Adv Ther. 2024 Apr;41(4):1553-1575. doi: 10.1007/s12325-023-02728-2. Epub 2024 Feb 16.
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.
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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2013-001497-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1517-CL-0613
Identifier Type: -
Identifier Source: org_study_id
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