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Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis (ALPS)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01887600
First Posted: June 27, 2013
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
FibroGen
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
  Purpose
This study is conducted to treat anemia in patients with chronic kidney disease. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin is important for the transport of oxygen in your blood. The purpose of the study is to see if Roxadustat is both effective and safe as a treatment for anemia in patients with chronic kidney disease.

Condition Intervention Phase
Anemia in Chronic Kidney Disease in Non-dialysis Patients Drug: Roxadustat Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):

Primary Outcome Measures:
  • Hemoglobin (Hb) response to treatment with Roxadustat without the use of rescue therapy [ Time Frame: Up to week 24 ]
  • Change in Hb from Baseline (BL) to the average level regardless of rescue therapy [ Time Frame: Baseline and week 28 to week 52 ]

Secondary Outcome Measures:
  • Hb maintenance: Hb change from BL to the average Hb, without having received rescue therapy within 6 weeks prior to and during the 8-week evaluation period (weeks 28 to 36) [ Time Frame: Baseline and weeks 28 to 36 ]
  • Change from BL in low-density lipoprotein (LDL) cholesterol to the average value of LDL cholesterol [ Time Frame: Baseline and weeks 12 to 28 ]
  • Use of rescue therapy [ Time Frame: Up to 24 weeks ]
    Rescue therapy: composite of Red Blood Cell (RBC) transfusions, Erythropoiesis-Stimulating Agent (ESA) use and Intravenous (IV) iron

  • Time to use of rescue therapy [ Time Frame: Up to 24 weeks ]
  • Change from BL in Short Form (SF)-36 Physical Functioning (PF) subscore to the average SF-36 PF subscore [ Time Frame: Baseline and weeks 12 to 28 ]
  • Change from BL in SF-36 Vitality (VT) subscore to the average SF-36 VT subscore [ Time Frame: Baseline and weeks 12 to 28 ]
  • Change from BL in Mean Arterial Pressure (MAP) to the average MAP [ Time Frame: Baseline and weeks 20 to 28 ]
  • Occurrence of hypertension [ Time Frame: Up to week 108 ]
    Defined as either systolic blood pressure [SBP] > 170 mmHg and an increase from BL greater than or equal to 20 mmHg or as DBP > 110 mmHg, and an increase from BL of greater than or equal to 15 mmHg)

  • Time to occurrence of hypertension [ Time Frame: Up to week 108 ]
  • Hb averaged over weeks 28-36, without use of rescue therapy within 6 weeks prior to and during the evaluation period [ Time Frame: Up to week 36 ]
  • Time to achieve the first Hb response as defined by primary endpoint [ Time Frame: Up to week 24 ]
  • Hb change from BL to each post-dosing time point [ Time Frame: Baseline up to End of Study (EOS) (Up to week 108) ]
  • Hb level averaged over weeks 44-52, without use of rescue therapy within 6 weeks prior to and during the evaluation period [ Time Frame: Up to week 52 ]
  • Hb change from BL to the average Hb value, regardless of the use of rescue therapy [ Time Frame: Baseline, week 28 to week 36 and week 44 to week 52 ]
  • Proportion of Hb values within 10.0-12.0 g/dL in weeks 28-36, without use of rescue therapy within 6 weeks prior to and during the 8-week evaluation period [ Time Frame: Up to week 36 ]
  • Occurrence of hospitalization [ Time Frame: Up to End of Treatment (EOT) (Up to week 104) ]
  • Number of days of hospitalization [ Time Frame: Up to End of Treatment (EOT) (Up to week 104) ]
  • Number of subjects having received RBC transfusions [ Time Frame: Up to End of Treatment (EOT) (Up to week 104) ]
  • Number of RBC packs per subject [ Time Frame: Up to End of Treatment (EOT) (Up to week 104) ]
  • Volume of RBC transfused per subject [ Time Frame: Up to End of Treatment (EOT) (Up to week 104) ]
  • Number of subjects having received IV iron therapy [ Time Frame: Up to End of Treatment (EOT) (Up to week 104) ]
  • Number of Erythropoiesis-Stimulating Agent (ESA)-week dose per subject [ Time Frame: Up to End of Treatment (EOT) (Up to week 104) ]
    1-3 doses of epoetin alfa or beta or biosimilar thereof (in EU) administered within 1 week = 1 ESA-week; 1 darbepoetin SQ or IV dose = 2 ESA-week; 1 Mircera IV or subcutaneous (SQ) dose = 4 ESA-week

  • Change from BL to each post-dosing visit in total cholesterol [ Time Frame: Baseline up to End of Study (EOS) (Up to week 108) ]
  • Change from BL to each post-dosing visit in low density lipoprotein (LDL)/high-density lipoprotein (HDL) ratio [ Time Frame: Baseline up to End of Study (EOS) (Up to week 108) ]
  • Change from BL to each post-dosing visit in non-HDL cholesterol [ Time Frame: Baseline up to End of Study (EOS) (Up to week 108) ]
  • Occurrence of mean LDL cholesterol < 100 mg/dLdL (mean LDL calculated over weeks 12-28 of treatment) [ Time Frame: Up to week 28 ]
  • Occurrence of achieved antihypertensive treatment goal in CKD subjects (SBP < 130 mmHg and DBP < 80 mmHg) based on the mean SBP and mean DBP calculated over weeks 12-28 of treatment with study drug [ Time Frame: Up to week 28 ]
  • Change from BL to the average value in Physical Component Score of SF-36 [ Time Frame: Baseline and weeks 12 to 28 ]
  • Change from BL to the average value in Anemia Subscale ("Additional Concerns") of Functional Assessment of Cancer Therapy-Anemia (FACT-An) Score [ Time Frame: Baseline and weeks 12 to 28 ]
  • Change from BL to the average value in Total FACT-An Score [ Time Frame: Baseline and weeks 12 to 28 ]
  • Change from BL to the average value in Health Related Quality of Life Questionnaire consisting of Five Levels (EQ-5D 5) visual analogue scale (VAS) Score [ Time Frame: Baseline and weeks 12 to 28 ]
  • Patients' Global Impression of Change (PGIC) [ Time Frame: Up to End of Treatment (EOT) (Up to week 104) ]
  • Changes from BL to each study visit in hepcidin [ Time Frame: Baseline up to End of Study (EOS) (Up to week 108) ]
    Serum hepcidin

  • Changes from BL to each study visit in HbA1c [ Time Frame: Baseline up to End of Study (EOS) (Up to week 108) ]
    Hemoglobin A1c glycated hemoglobin (HbA1c) level

  • Time to first occurrence of serum Cr having doubled during study [ Time Frame: Up to End of Study (EOS) (Up to week 108) ]
  • Occurrence of ESRD [ Time Frame: Up to End of Study (EOS) (Up to week 108) ]
    End Stage Renal Disease (ESRD)

  • Safety assessed by nature, frequency, and severity of Adverse Events (AEs) [ Time Frame: Up to End of Study (EOS) (Up to week 108) ]
  • Safety assessed by nature, frequency, and severity of Serious Adverse Events (SAEs) [ Time Frame: Up to End of Study (EOS) (Up to week 108) ]
  • Number of participants with vital signs abnormalities and/or adverse events related to treatment [ Time Frame: Up to End of Study (EOS) (Up to week 108) ]
  • Safety assessed by 12- lead electrocardiogram (ECG) [ Time Frame: Up to End of Study (EOS) (Up to week 108) ]
    Local 12-lead ECGs will be performed on all subjects at specific time points. A single ECG will be taken with the subject in the supine position, after the subject has been lying quietly for 5 minutes

  • Number of participants with laboratory value abnormalities and/or adverse events related to treatment [ Time Frame: Up to End of Study (EOS) (Up to week 108) ]
  • Changes from BL to each study visit in serum ferritin [ Time Frame: Baseline up to End of Study (EOS) (Up to week 108) ]
  • Changes from BL to each study visit in Transferrin Saturation (TSAT) [ Time Frame: Baseline up to End of Study (EOS) (Up to week 108) ]
  • Changes from BL to each study visit in estimated Glomerular Filtration Rate (eGFR), including eGFR slope over time [ Time Frame: Baseline up to End of Study (EOS) (Up to week 108) ]
  • Changes from BL to each study visit in urine albumin/Creatinine (Cr) ratio [ Time Frame: Baseline up to End of Study (EOS) (Up to week 108) ]
  • Changes from BL to each study visit in fasting blood glucose [ Time Frame: Baseline up to End of Study (EOS) (Up to week 108) ]
  • Change from BL to each post-dosing visit in Apolipoproteins (Apo) A1 [ Time Frame: Baseline up to End of Study (EOS) (Up to week 108) ]
  • Change from BL to each post-dosing visit in Apolipoproteins B (ApoB) [ Time Frame: Baseline up to End of Study (EOS) (Up to week 108) ]
  • Change from BL to each post-dosing visit in ApoB/ApoA1 ratio [ Time Frame: Baseline up to End of Study (EOS) (Up to week 108) ]

Enrollment: 597
Actual Study Start Date: September 3, 2013
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Roxadustat
Study drug will be dosed three times weekly (TIW) during correction period and three times weekly (TIW) during the maintenance period. Dose adjustments will be made during the study
Drug: Roxadustat
tablet
Other Names:
  • ASP1517
  • FG-4592
Placebo Comparator: Placebo
Placebo will be dosed three times weekly (TIW) during correction period and three times weekly (TIW) during the maintenance period. Dose adjustments will be made during the study
Drug: Placebo
tablet

Detailed Description:

The study will consist of three study periods as follows:

  • 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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Subject has a diagnosis of chronic kidney disease, with Kidney Disease Outcomes Quality Initiative (KDOQI) Stage 3, 4 or 5, not receiving dialysis; with an Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73 m^2 estimated using the abbreviated 4-variable Modification of Diet in Renal Disease (MDRD) equation.
  • The mean of the subject'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.
  • Subject has a ferritin level greater than or equal to 30 ng/mL (greater than or equal to 67.4 pmol/L) at screening.
  • Subject has a transferrin saturation (TSAT) level greater than or equal to 5% at screening.
  • Subject has a serum folate level greater than or equal to lower limit of normal at screening.
  • Subject has a serum vitamin B12 level greater than or equal to lower limit of normal at screening.
  • Subject'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.
  • Subject's body weight is 45.0 kg up to a maximum of 160.0 kg.

Exclusion criteria:

  • Subject has received any ESA treatment within 12 weeks prior to randomization.
  • Subject has had more than one dose of IV iron within 12 weeks prior to randomization.
  • Subject has received a RBC transfusion within 8 weeks prior to randomization.
  • Subject has a known history of myelodysplastic syndrome or multiple myeloma.
  • Subject 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.
  • Subject has a known hemosiderosis, hemochromatosis, coagulation disorder, or hypercoagulable condition.
  • Subject has chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosus, rheumatoid arthritis, celiac disease) even if it is currently in remission.
  • Subject is anticipated to have elective surgery that is expected to lead to significant blood loss or anticipated elective coronary revascularization.
  • Subject has active or chronic gastrointestinal bleeding.
  • Subject has received any prior treatment with roxadustat or a hypoxia-inducible factor Prolyl Hydroxylase Inhibitor (HIF-PHI).
  • Subject has been treated with iron-chelating agents within 4 weeks prior to randomization.
  • Subject has a history of chronic liver disease (e.g., cirrhosis or fibrosis of the liver)
  • Subject has a known New York Heart Association Class III or Intravenous (IV) congestive heart failure.
  • Subject 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.
  • Subject 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.
  • Subject 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.
  • Subject 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).
  • Subject 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.
  • Subject has a known untreated proliferative diabetic retinopathy, diabetic macular edema, macular degeneration and retinal vein occlusion.
  • Subject has had any prior organ transplant (that has not been explanted) or a scheduled organ transplantation.
  • Subject 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.
  • Subject 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.
  • Subject has a history of alcohol or drug abuse within 2 years prior to randomization.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887600


  Hide Study Locations
Locations
Belarus
Site BY37503
Brest, Belarus, 224027
Site BY37504
Gomel, Belarus, 246027
Site BY37501
Grodno, Belarus, 230017
Site BY37506
Minsk, Belarus, 220036
Site BY37507
Minsk, Belarus, 220116
Site BY37505
Minsk, Belarus, 223040
Site BY37502
Vitebsk, Belarus, 210037
Belgium
Site BE32004
Brussels, Flemish Brabant, Belgium, 1200
Site BE32002
Antwerp, Belgium, 2060
Site BE32012
Baudour, Belgium, 7331
Site BE32017
Bonheiden, Belgium, 2820
Site BE32014
Ieper, Belgium, 8900
Site BE32005
Liege, Belgium, 4000
Site BE32013
Liege, Belgium, 4000
Bulgaria
Site BG35923
Pazardjik, Bulgaria, 4400
Site BG35906
Sofia, Bulgaria, 1431
Site BG35908
Sofia, Bulgaria, 1431
Site BG35910
Sofia, Bulgaria, 1431
Site BG35907
Stara Zagora, Bulgaria, 6000
Site BG35916
Varna, Bulgaria, 9000
Site BG35903
Veliko Tarnovo, Bulgaria, 5000
Colombia
Site CO57007
Barranquilla, Colombia
Site CO57008
Barranquilla, Colombia
Site CO57002
Pereira, Colombia
Dominican Republic
Site DO17101
La Fe Santo Domingo, Dominican Republic, 5072
Site DO17102
Santiago de los Caballeros, Dominican Republic, 51000
Site DO17104
Santo Domingo, Dominican Republic, 10124
Site DO17103
Santo Domingo, Dominican Republic, 103201
Estonia
Site EE37201
Tallinn, Estonia, 13419
Georgia
Site GE99503
Tbilisi, Georgia, 0144
Site GE99504
Tbilisi, Georgia, 0144
Site GE99502
Tbilisi, Georgia, 0159
Greece
Site GR30003
Heraklion, Greece, 71409
Site GR30002
Patras, Greece, 26504
Site GR30001
Thessaloniki, Greece, 54642
Guatemala
Site GT50209
Chiquimula, Guatemala, 01001
Site GT50202
Ciudad de Guatemala, Guatemala, AP 01015
Site GT50208
Ciudad de Guatemala, Guatemala, CP 01001
Site GT50207
Ciudad de Guatemala, Guatemala, CP 01010
Site GT50201
Ciudad de Guatemala, Guatemala, CP 01016
Site GT50205
Guatemala, Guatemala, 01010
Site GT50206
Guatemala, Guatemala, 01010
Site GT50203
Guatemala, Guatemala, 01014
Hungary
Site HU36029
Budapest, Hungary, H-1036
Site HU36025
Gyor, Hungary, 9002
Site HU36026
Kaposvar, Hungary, H 7400
Site HU36027
Kistarcsa, Hungary, 2143
Site HU36008
Pecs, Hungary, H 7624
Site HU36028
Szent, Hungary, H-1097
Site HU36003
Zalsaegerszeg, Hungary, 8900
Italy
Site IT39001
Bari, Italy, 70124
Site IT39008
Lecco, Italy, 23900
Site IT39006
Milano, Italy, 20162
Site IT39037
Modena, Italy, 41124
Site IT39036
Pavia, Italy, 27100
Panama
Site PA50703
Ciudad de Colon, Panama, 0302-00504 Z.L.
Site PA50701
Ciudad de Panama, Panama
Peru
Site PE51001
Iquitos, Peru, 16001
Site PE51002
Trujillo, Peru, 13001
Poland
Site PL48001
Krakow, Malopolska, Poland, 31-559
Site PL48002
Katowice, Poland, 40 027
Site PL48058
Kutno, Poland, 99-300
Site PL48012
Lodz, Poland, 90549
Site PL48008
Lodz, Poland, 92-213
Site PL48057
Nowy Tomyśl, Poland, 64-300
Site PL48018
Opole, Poland, 45-418
Site PL48013
Szczecin, Poland, 70-111
Site PL48007
Tarnow, Poland, 33 100
Site PL48005
Warszawa, Poland, 02-507
Site PL48004
Warszawa, Poland, 04 749
Site PL48006
Wroclaw, Poland, 50-556
Site PL48014
Zamosc, Poland, 20-400
Romania
Site RO40005
Timisoara, Timis, Romania, 300736
Site RO40001
Brasov, Romania, 500366
Site RO40021
Bucharest, Romania, 022328
Site RO40012
Bucuresti, Romania, 10825
Site RO40003
Bucuresti, Romania, 22328
Site RO40007
Iasi, Romania, 700506
Site RO40004
Oradea, Romania, 410469
Russian Federation
Site RU70024
Chelyabinsk, Russian Federation, 454047
Site RU70054
Irkutsk, Russian Federation, 664079
Site RU70008
Kaluga, Russian Federation, 248007
Site RU70051
Moscow, Russian Federation, 119992
Site RU70007
Moscow, Russian Federation, 123182
Site RU70005
Moscow, Russian Federation, 125284
Site RU70048
Moscow, Russian Federation, 129301
Site RU70047
Moscow, Russian Federation, 129327
Site RU70003
Nizhny Novgorod, Russian Federation, 603032
Site RU70004
Omsk, Russian Federation, 644112
Site RU70043
Petrozavodsk, Russian Federation, 185019
Site RU70014
Rostov-on-don, Russian Federation, 344029
Site RU70022
Saint Petersburg, Russian Federation, 192242
Site RU70011
Saint Petersburg, Russian Federation, 196247
Site RU70002
Saint Petersburg, Russian Federation, 197089
Site RU70045
Saint-Petersburg, Russian Federation, 194354
Site RU70060
Saratov, Russian Federation, 410039
Site RU70006
Smolensk, Russian Federation, 214006
Site RU70057
Yaroslavl, Russian Federation, 150045
Site RU70001
Yaroslavl, Russian Federation, 150062
Serbia
Site RS38102
Belgrade, Serbia, 11000
Site RS38104
Belgrade, Serbia, 11000
Site RS38105
Belgrade, Serbia, 11000
Site RS38103
Belgrade, Serbia, 11080
Site RS38117
Krusevac, Serbia, 37000
Site RS38101
Nis, Serbia, 18000
Site RS38116
Zrenjanin, Serbia, 23000
South Africa
Site ZA27001
Observatory, Cape Town, South Africa, 7925
Site ZA27004
Bloemfontein, Free State, South Africa, 9324
Site ZA27002
Durban, Kwa Zulu Natal, South Africa, 4001
Site ZA27008
Durban, South Africa, 4001
Site ZA27006
Parow, South Africa, 7500
Site ZA27007
Port Elizabeth, South Africa, 6001
Spain
Site ES34001
Bilbao, Bizkaia, Spain, 48013
Site ES34010
Alcorcon, Madrid, Spain, 28922
Site ES34011
Galdakao, Vizcaya, Spain, 48960
Site ES34044
Avila, Spain, 05004
Site ES34002
Badalona-Barcelona, Spain, 8916
Site ES34003
Barcelona, Spain, 08003
Site ES34006
Barcelona, Spain, 08035
Site ES34007
Ciudad Real, Spain, 13005
Turkey
Site TR90003
Ankara, Turkey, 6340
Site TR90016
Edirne, Turkey, 22030
Site TR90024
Kocaeli, Turkey, 41380
Site TR90020
Malatya, Turkey, 44300
Ukraine
Site UA38009
Lviv, Lvivska, Ukraine, 79010
Site UA38021
Cherkasy, Ukraine, 18009
Site UA38003
Chernivtsi, Ukraine, 58002
Site UA38006
Dnepropetrovsk, Ukraine, 49005
Site UA38016
Ivano-Frankivsk, Ukraine, 76018
Site UA38011
Kharkiv, Ukraine, 61103
Site UA38015
Kherson, Ukraine, 73000
Site UA38010
Kyiv, Ukraine, 01016
Site UA38012
Kyiv, Ukraine, 02125
Site UA38017
Kyiv, Ukraine, 04050
Site UA38007
Mykolaiv, Ukraine, 54058
Site UA38008
Odessa, Ukraine, 65000
Site UA38019
Odessa, Ukraine, 65026
Site UA38001
Ternopil, Ukraine, 46002
Site UA38018
Uzhgorod, Ukraine, 88018
Site UA38002
Zaporizhzhya, Ukraine, 69600
United Kingdom
Site GB44008
Cambridge, United Kingdom, CB5 8QD
Site GB44077
Portsmouth, United Kingdom, PO63LY
Site GB44001
Swansea, United Kingdom, SA6 6NL
Site GB44005
Welwyn Garden City, United Kingdom, AL7 4HQ
Site GB44004
Westcliff-on-Sea, United Kingdom, SS0 0RY
Sponsors and Collaborators
Astellas Pharma Europe B.V.
FibroGen
Investigators
Study Chair: Medical Monitor Astellas Pharma Europe B.V.
  More Information

Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT01887600     History of Changes
Other Study ID Numbers: 1517-CL-0608
2012-005180-27 ( EudraCT Number )
First Submitted: June 25, 2013
First Posted: June 27, 2013
Last Update Posted: October 31, 2017
Last Verified: October 2017

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):
anemia
chronic kidney disease (CKD)
Hemoglobin (Hb)
non-dialysis

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency