Roxadustat in the treatment of anemia in chronic kidney disease patients

• Register: EUCTR
• Last refreshed on: 23 November 2020
• Main ID: EUCTR2013-000951-42-NL
• Date of registration: 04/11/2013
• Prospective Registration: Yes
• Primary sponsor: Astellas Pharma Europe B.V.
• Public title: Roxadustat 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 Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis - Dolomites
• Date of first enrolment: 13/08/2014
• 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: 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

Austria, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Israel, Latvia, Macedonia, the former Yugoslav Republic of, Montenegro, Netherlands, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Spain, Sweden, Ukraine, United Kingdom

Contacts

• Name: Service Desk
• Affiliation: Astellas Pharma Europe B.V.- Global Development Operations

• Name: Service Desk
• Affiliation: Astellas Pharma Europe B.V.- Global Development Operations

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 two most recent (prior to randomization) Hb values during the screening period, obtained at least 4 days apart, must be =10.5 g/dL, with a difference of =1.0 g/dL. 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) =95mm Hg, 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: 19.0 Level: LLT Classification code 10002272 Term: Anemia System Organ Class: 100000004851

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

Intervention(s)

Product Name: Roxadustat
Product Code: FG-4592/ASP1517 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 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 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-

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 microgram(s)
Concentration type: equal
Concentration number: 40-

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

Primary Outcome(s)

Main Objective: To evaluate the efficacy of roxadustat compared to Darbepoetin alfa in the treatment of anemia in non-dialysis dependent Chronic Kidney Disease (NDD-CKD)
subjects.

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 prior to Hb response.

Secondary Objective: Evaluate the safety of roxadustat compared to Darbepoetin alfa in the treatment of anemia in NDD-CKD subjects.

Evaluate the health-related quality of life (HRQoL) benefit of roxadustat compared to Darbepoetin alfa in the treatment of anemia in NDD-CKD subjects.

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

Secondary Outcome(s)

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

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)
-Change from BL in 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 subscore of weeks 12 to 28
- Blood pressure effect:
o Change from BL in mean arterial pressure (MAP) to the average MAP value of weeks 20 to 28
o Occurrence & time to occurrence of hypertension (defined as either systolic blood pressure [SBP] >170 mmHg AND an increase from BL of =20 mmHg SBP or diastolic blood pressure [DBP] >110 mmHg AND an increase from BL of =15 mmHg DBP on 2 consecutive visits) 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 sub-score of weeks 12 to 28

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: 13/08/2014
Contact:

Results

• Results available: Yes
• Date Posted: 04/11/2020
• Date Completed: 15/11/2019
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-000951-42/results