Roxadustat in the treatment of anemia in end stage renal disease patients on stable dialysis.

• Register: EUCTR
• Last refreshed on: 20 August 2018
• Main ID: EUCTR2013-001497-16-HU
• Date of registration: 03/10/2014
• Prospective Registration: No
• Primary sponsor: Astellas Pharma Europe B.V.
• Public title: Roxadustat in the treatment of anemia in end stage renal disease patients on stable dialysis.
• Scientific title: A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Maintenance Treatment of Anemia in End Stage Renal Disease Subjects on Stable Dialysis - Pyrenees
• Date of first enrolment: 30/09/2014
• Target sample size: 750
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001497-16
• 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: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Bulgaria, Croatia, Czech Republic, France, Georgia, Germany, Hungary, Italy, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Spain, 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 age is =18 years.
Subject is on stable HD, HDF or PD treatment with the same mode of dialysis for =4 months prior to randomization.
Subject is on IV or SC epoetin (i.e. epoetin alfa, beta, theta, zeta, delta or omega) or IV or SC darbepoetin alfa treatment for =8 weeks prior to randomization with stable weekly doses.
Mean of the subject’s three most recent Hb values, as measured by central laboratory, during the Screening Period.
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.
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 550
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion criteria:
Subject has received a Red Blood Cell (RBC) transfusion within 8 weeks prior to randomization.
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 Chronic Kidney Disease (CKD).
Subject 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.
Subject has had uncontrolled hypertension, in the opinion of the investigator, within two weeks prior to randomization.
Subject 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.
Subject has had any prior organ transplant (that has not been explanted), or subject is scheduled for organ transplantation.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Anemia in End Stage Renal Disease (ESRD) subjects on stable dialysis.
MedDRA version: 18.1 Level: LLT Classification code 10002272 Term: Anemia System Organ Class: 100000004851

Intervention(s)

Product Name: roxadustat
Product Code: FG-4592/ASP1517 - 20 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: 20-

Product Name: roxadustat
Product Code: FG-4592/ASP1517 - 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 Name: roxadustat
Product Code: FG-4592/ASP1517 - 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/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 40-

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/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: Aranesp
Product Name: Aranesp 40 mcg 4 FS
Pharmaceutical Form: Solution for injection
INN or Proposed INN: darbepoetin alfa
CAS Number: 209810-58-2
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: Aranesp
Product Name: Aranesp 60 mcg 4 FS
Pharmaceutical Form: Solution for injection
INN or Proposed INN: darbepoetin alfa
CAS Number: 209810-58-2
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 200-

Trade Name: Aranesp
Product Name: Aranesp 100 mc

Primary Outcome(s)

Primary end point(s): There are two separate regionally based primary efficacy endpoints in this study, depending upon whether the data are being filed to support submission to the US Food and Drug Administration (FDA) or to Ex-US health authorities, such as the European Medicines Agency (EMA).

? The EU (EMA) primary efficacy endpoint is change in Hb from baseline (BL) to the average level during the evaluation period (defined as week 28 until week 36), without having received rescue therapy (i.e. RBC transfusion for all subjects or ESA for subjects treated with roxadustat) within 6 weeks prior to and during this 8-week evaluation period.
? The US (FDA) primary efficacy endpoint is change in Hb from BL to the average level during the evaluation period (defined as week 28 until week 52), regardless of rescue therapy.

Timepoint(s) of evaluation of this end point: 36 weeks (for EU primary endpoint) or 52 weeks (for US primary enpoint)

Secondary Objective: Evaluate the safety of roxadustat compared to epoetin alfa and darbepoetin alfa in the maintenance treatment of anemia in ESRD subjects on stable dialysis.

Evaluate the effects on health-related quality of life of roxadustat compared to epoetin alfa and darbepoetin alfa in the maintenance treatment of anemia in ESRD subjects on stable dialysis.

Main Objective: Evaluate the efficacy of roxadustat compared to epoetin alfa and darbepoetin alfa in the maintenance treatment of anemia in End Stage Renal Disease (ESRD) subjects on stable dialysis.

Secondary Outcome(s)

Secondary end point(s): Hb response defined as mean Hb during weeks 28 to 36 within the target range of 10.0 to 12.0 g/dL without having received rescue therapy within 6 weeks prior to and during this 8 week evaluation period.
Change from BL in Short Form 36 (SF-36) Physical Functioning(PF) sub-score to the average PF sub-score of weeks 12 to 28.
Change from BL in SF-36 Vitality (VT) sub-score to the average VT sub-score of weeks 12 to 28.

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

Secondary ID(s)

2013-001497-16-GB

1517-CL-0613

Source(s) of Monetary Support

Astellas Pharma Europe B.V.