Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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16 December 2019 |
Main ID: |
EUCTR2013-000951-42-ES |
Date of registration:
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31/10/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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FG-4592 in the treatment of anemia in chronic kidney disease patients
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Scientific title:
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A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate
the Efficacy and Safety of FG-4592 in the Treatment of Anemia in Chronic
Kidney Disease Patients Not on Dialysis
- Dolomites |
Date of first enrolment:
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26/12/2013 |
Target sample size:
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570 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000951-42 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 4
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Bulgaria
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Croatia
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Czech Republic
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Denmark
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Finland
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France
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Germany
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Ireland
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Israel
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Latvia
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Netherlands
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Portugal
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Slovakia
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Slovenia
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Spain
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Sweden
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United Kingdom
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Contacts
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Name:
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Service Desk - Global Clinical Dev.
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Address:
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Sylviusweg 62
2333 BE
Leiden
Netherlands |
Telephone:
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+31715455050 |
Email:
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contact@nl.astellas.com |
Affiliation:
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Astellas Pharma Europe B.V. |
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Name:
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Service Desk - Global Clinical Dev.
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Address:
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Sylviusweg 62
2333 BE
Leiden
Netherlands |
Telephone:
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+31715455050 |
Email:
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contact@nl.astellas.com |
Affiliation:
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Astellas Pharma Europe B.V. |
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Key inclusion & exclusion criteria
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Inclusion criteria: Subject is eligible for the study if all of the following apply: Subject age is ? 18 years. Subject has a diagnosis of CKD, with Kidney Disease Outcomes Quality Initiative (KDOQI) Stage 3, 4 or 5, not on dialysis; with an eGFR <60 mL/min/1.73 m2 estimated using the abbreviated 4-variable Modification of Diet in Renal Disease (MDRD) equation. The mean of the subject?s three most recent (prior to randomization) Hb values during the Screening period, obtained at least 4 days apart, must be ?10.0 g/dL, with a difference of ?1.0 g/dL between the highest and the lowest values. The last Hb value must be within 10 days prior to randomization. Subject?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. Subject?s body weight is 45.0 kg to a maximum of 160.0 kg. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 170
Exclusion criteria: Subject will be excluded from participation if any of the following apply: Subject has received any ESA treatment within 12 weeks prior to randomization. Subject has received any dose of IV iron within 6 weeks prior to randomization. Subject has received a Red Blood Cell (RBC) transfusion within 8 weeks prior to randomization Subject has a known chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosus, rheumatoid arthritis, celiac disease) even if it is currently in remission. Subject has had a myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization. Subject has an uncontrolled hypertension in the opinion of the investigator, or two or more blood pressure values of systolic blood pressure (SBP) ?160 mmHg or diastolic blood pressure (DBP) ?95mmHg, within 2 weeks prior to randomization.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Anemia in Chronic Kidney Disease patients not on Dialysis
MedDRA version: 14.1
Level: LLT
Classification code 10002272
Term: Anemia
System Organ Class: 100000004851
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Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
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Intervention(s)
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Product Code: FG-4592 20mg Pharmaceutical Form: Tablet INN or Proposed INN: roxadustat CAS Number: 808118-40-3 Current Sponsor code: FG-4592 Other descriptive name: ASP1517 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20-
Product Code: FG-4592 - 50 mg Pharmaceutical Form: Tablet INN or Proposed INN: roxadustat CAS Number: 808118-40-3 Current Sponsor code: FG-4592 Other descriptive name: ASP1517 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50-
Product Code: FG-4592 - 100 mg Pharmaceutical Form: Tablet INN or Proposed INN: roxadustat CAS Number: 808118-40-3 Current Sponsor code: FG-4592 Other descriptive name: ASP1517 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-
Trade Name: Aranesp Product Name: Aranesp 20 mcg 4 FS Pharmaceutical Form: Solution for injection INN or Proposed INN: DARBEPOETIN ALFA CAS Number: 209810-58-2 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 20-
Trade Name: Aranesp Product Name: Aranesp 30 mcg 4 FS Pharmaceutical Form: Solution for injection INN or Proposed INN: DARBEPOETIN ALFA CAS Number: 209810-58-2 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 30-
Tra
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Primary Outcome(s)
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Secondary Objective: Evaluate the safety of FG-4592 compared to Darbepoetin alfa in the treatment of anemia in non-dialysis CKD subjects.
Evaluate the health-related quality of life (HRQoL) benefit of FG-4592 compared to Darbepoetin alfa in the treatment of anemia in non-dialysis CKD subjects.
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Primary end point(s): The primary efficacy endpoint is Hb response defined as: - Hb ?11.0 g/dL and a Hb increase from BL Hb by ?1.0 g/dL in any subject with BL Hb>8.0 g/dL, OR - An increase from BL Hb by ?2.0 g/dL in any subject with BL Hb ?8.0 g/dL as measured at 2 consecutive visits separated by at least 5 days during the first 24 weeks of treatment without administration of rescue therapy (i.e., RBC transfusion for all subjects or darbepoetin alfa for FG-4592 treated subjects) prior to Hb response.
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Timepoint(s) of evaluation of this end point: 36 Weeks
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Main Objective: To evaluate the efficacy of FG-4592 compared to Darbepoetin alfa in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) subjects.
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Secondary Outcome(s)
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Secondary end point(s): - Hb change from BL Hb to the average Hb of weeks 28 to 36, without having received rescue therapy within 6 weeks prior to and during this 8-week evaluation period - Change from BL in Low Density Lipoprotein (LDL) cholesterol to the average LDL cholesterol of weeks 12 to 28 - Mean monthly IV iron (mg) use per subject during weeks 1 to 36 (monthly defined as a period of 4 weeks) - Blood pressure effect: o Change from BL in mean arterial pressure (MAP) to the average MAP value of weeks 20 to 28 o Occurrence of hypertension (SBP >170 mmHg or DBP >110 mmHg, or an increase from BL of ?15 mmHg [DBP] or ?20 mmHg [SBP] on 2 consecutive visits) or intensification of antihypertensive therapy during weeks 1 to 36 - Change from BL in SF-36 Physical Functioning (PF) sub-score to the average PF subscore of weeks 12 to 28 - Change from BL in SF-36 Vitality (VT) sub-score to the average VT subscore of weeks 12 to 28
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Timepoint(s) of evaluation of this end point: 36 weeks
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Secondary ID(s)
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1517-CL-0610
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2013-000951-42-GB
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Source(s) of Monetary Support
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Astellas Pharma Europe B.V.
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Ethics review
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Status: Approved
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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