FG-4592 in the treatment of anemia in chronic kidney disease patients

• Register: EUCTR
• Last refreshed on: 1 February 2020
• Main ID: EUCTR2013-000951-42-FR
• Date of registration: 14/05/2014
• Prospective Registration: No
• Primary sponsor: Astellas Pharma Europe B.V.
• Public title: FG-4592 in the treatment of anemia in chronic kidney disease patients
• Scientific title: 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: 24/04/2014
• Target sample size: 570
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000951-42
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Israel, Latvia, Netherlands, Portugal, Slovakia, Slovenia, Spain, Sweden, United Kingdom

Contacts

• Name: Service Desk - Global Clinical Dev.
• Affiliation: Astellas Pharma Europe B.V.

• Name: Service Desk - Global Clinical Dev.
• Affiliation: Astellas Pharma Europe B.V.

Key inclusion & exclusion criteria

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

Health Condition(s) or Problem(s) studied

Anemia in Chronic Kidney Disease patients not on Dialysis
MedDRA version: 17.0 Level: LLT Classification code 10002272 Term: Anemia System Organ Class: 100000004851

Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Intervention(s)

Product Code: FG-4592 20mg
Pharmaceutical Form: Tablet
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
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
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
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

Primary Outcome(s)

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.

Timepoint(s) of evaluation of this end point: 36 Weeks

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.

Primary end point(s): The primary objective of this study is to establish non-inferiority in efficacy of FG-4592 compared to Darbepoetin alfa in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) subjects.

Secondary Outcome(s)

Secondary end point(s): Compare the safety of FG-4592 to Darbepoetin alfa in the treatment of anemia in non dialysis CKD subjects.

Compare health-related quality of life (HRQoL) benefit of FG-4592 to Darbepoetin alfa in the treatment of anemia in non-dialysis CKD subjects.

Timepoint(s) of evaluation of this end point: 36 weeks

Secondary ID(s)

1517-CL-0610

2013-000951-42-GB

Source(s) of Monetary Support

Astellas Pharma Europe B.V.

Ethics review

Status: Approved
Approval date: 24/04/2014
Contact: