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Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis (Pyrenees)

Primary Purpose

Anemia, End Stage Renal Disease (ESRD)

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Roxadustat

Epoetin alfa

Darbepoetin alfa

Iron

About this trial

This is an interventional treatment trial for Anemia focused on measuring ASP1517, FG-4592, Anemia, End Stage Renal Disease (ESRD), Erythropoetin Stimulating Agents (ESAs), Chronic Kidney Disease, Hematopoetic Agents, HIF-PH inhibitor, Hemoglobin, Dialysis, roxadustat

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Main Inclusion:

Participant is on stable hemodialysis (HD), hemodiafiltration (HDF) or peritoneal dialysis (PD) treatment with the same mode of dialysis for ≥4 months prior to randomization.
Participant is on IV or SC epoetin or IV or SC darbepoetin alfa treatment for ≥8 weeks prior to randomization with stable weekly doses (during 4 weeks prior to randomization).
Mean of the participant's three most recent Hb values, as measured by central laboratory, during the Screening Period.
Participant'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

Exclusion Criteria:

Main Exclusion:

Participant has received a red blood cell (RBC) transfusion within 8 weeks prior to randomization.
Participant 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).
Participant 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.
Participant has had uncontrolled hypertension, in the opinion of the investigator, within 2 weeks prior to randomization.
Participant 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.
Participant has had any prior organ transplant (that has not been explanted), or participant is scheduled for organ transplantation.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Roxadustat

ESA (Erythropoiesis Stimulating Agent) treatment

Arm Description

Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.

Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from the epoetin alfa to darbepoetin alfa or vice versa.

Outcomes

Primary Outcome Measures

Change From Baseline (BL) to the Average Hemoglobin (Hb) in Weeks 28-36 Without Rescue Therapy [EU (EMA)]

Baseline Hb was defined as the mean of four central laboratory Hb values; four latest Hb values prior or on the same date as the first study drug intake. For participants who did not have an available Hb value during the week 28-36 period, imputation rules were applied. For analyses without rescue therapy, participants who used rescue therapy after the initiation of rescue therapy were set to missing for 6 weeks from the start date of rescue therapy. If no Hb value was available, an imputation technique was used, with the mean of all available values from Day 1 to minimum (End of Efficacy Emergent Period) carried forward.

Change From BL to the Average Hb in Weeks 28 to 52 Regardless of Rescue Therapy [US (FDA)]

Baseline Hb was defined as the mean of four central laboratory Hb values: four latest Hb values prior or on the same date as first study drug intake. Change from baseline to the average Hb are observed values. Missing hemoglobin data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the Monte Carlo Markov Chain (MCMC) imputation model with treatment, baseline hemoglobin, randomization stratification factors and the available non missing hemoglobin for each scheduled week.

Secondary Outcome Measures

Percentage of Participants With Hb Response During Weeks 28 to 36

Hb response during weeks 28-36, was defined as mean Hb from 10-12 g/dL without receiving rescue therapy in the 6 weeks prior to, or during, the evaluation period. The percentages and 95% CI were unadjusted, the exact method of Clopper-Pearson was used for 95% CI. The Efficacy Emergent Period was defined as the evaluation period from the Analysis date of first dose intake up to end of treatment (EOT) Visit or last non-missing Hb assessment (for participants who died during the treatment period).

Change From BL in Low Density Lipoprotein Cholesterol (LDL-C) to the Average LDL-C of Weeks 12 to 28

Baseline LDL was defined as the LDL value on Day 1. If this value was missing, the latest value prior to first study drug administration was used.

Mean Monthly Intravenous (IV) Iron Use

Participants with no or missing medication records of IV Iron have their monthly IV Iron use set to 0 mg. For participants who took IV Iron, but without a dosing frequency, the average values were set to missing.

Change From BL in Short Form-36 (SF-36) Health Survey Physical Functioning (PF) Sub-score to the Average of Weeks 12 to 28

Baseline SF-36 PF was defined as the SF-36 PF value on Day 1.The SF-36 is a Quality of Life (QoL) instrument designed to assess generic health concepts relevant across age, disease, and treatment groups. The SF-36 contains 36 items that measure eight scales: (1) physical functioning (PF); (2) role limitations due to physical health problems (RP); (3) bodily pain (BP); (4) social functioning (SF); (5) general health perceptions (GH); (6) role limitations due to emotional problems (RE); (7) vitality, energy or fatigue (VT); and (8) mental health(MH). Each scale is transformed into 0-100 score, with higher scores indicating better health status. The SF-36 PF consists of 11 questions focused on health and ability to do usual activities, with higher scores indicating better health status.

Change From BL in SF-36 Vitality (VT) Sub-score to the Average of Weeks 12 to 28

Baseline VT Subscore was defined as the VT value on Day 1. The SF-36 is a QoL instrument designed to assess generic health concepts relevant across age, disease, and treatment groups. The SF-36 vitality has four questions with score range from 0-100 with higher scores indicating better vitality status.

Change From BL in Mean Arterial Pressure (MAP) to the Average of Weeks 20 to 28

Baseline MAP was defined as the MAP value on Day 1. If this value was missing, the latest value prior to first study drug administration was used. Mean Arterial Pressure (MAP) is derived as: MAP = (2/3)*DBP + (1/3)*SBP.

Time to First Occurrence of an Increase in Blood Pressure

Increase in Blood Pressure was defined as either: Systolic Blood Pressure (SBP) ≥ 170 mmHg and an increase from BL ≥ 20 mmHg, or as: Diastolic Blood Pressure (DBP) ≥ 100 mmHg and an increase from BL ≥ 15 mmHg. For participants who have experienced more than one event, only their first event following study treatment was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula.

Change From BL in Mean Arterial Pressure (MAP) to the Average MAP Value of Weeks 20 to 28

Baseline MAP was defined as the MAP value on day 1. If this value was missing, the latest value prior to first study drug administration was used. Mean Arterial Pressure (MAP) is derived as: MAP = (2/3)*DBP + (1/3)*SBP.

Time to First Occurrence of an Increase in Blood Pressure

Increase in Blood Pressure was defined as either: SBP ≥ 170 mmHg and an increase from BL ≥ 20 mmHg, or as: DBP ≥ 100 mmHg and an increase from BL ≥ 15 mmHg. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula.

Percentage of Participants With a Hb Response During Weeks 28 and 36 Regardless of Use of Rescue Therapy

Hb response was defined as mean Hb during weeks 28 to 36 within the target range of 10.0 to 12.0 g/dL. The percentages and 95% CI are unadjusted, the exact method of Clopper-Pearson was used for 95% CI.

Change From BL in Hb to Each Postdosing Time Point

Baseline Hb was defined as the mean of four latest central laboratory Hb values prior or on the same date as first study drug intake (pre-dose).

Hb Level Averaged Over Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy

Baseline Hb was defined as the mean of four latest central laboratory Hb values prior or on the same date as first study drug intake (pre-dose). Averaged Hb values over weeks 28-36, weeks 44-52 and weeks 96-104 are observed values.

Change From BL in Hb to the Average of Weeks 28 to 36, 44 to 52, and 96 to 104 Regardless of the Use of Rescue Therapy

Change from baseline to the average Hb are observed values. Baseline Hb was defined as the mean of four latest central laboratory Hb values prior or on the same date as first study drug intake (pre-dose).

Percentage of Hb Values ≥ 10 g/dL in Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy

Percentage for each participant was calculated as Number of Hb values >= 10.0 g/dL / Total number of Hb values*100 in weeks 28 to 36, 44 to 52 and 96 to 104 without use of rescue therapy within 6 weeks prior to and during the 8 week evaluation period.

Percentage of Hb Values Within 10.0 to 12.0 g/dL in Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy

Percentage for each participant was calculated as Number of Hb values within 10.0-12.0 g/dL / Total number of Hb values*100 in weeks 28 to 36, 44 to 52 and 96 to 104 without use of rescue therapy within 6 weeks prior to and during the 8 week evaluation period.

Number of Hospitalizations

The number of hospitalizations per participant were calculated during the Efficacy Emergent Period. The Efficacy Emergent Period was defined as the evaluation period from the Analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period). It included all Non-Hemodialysis (HD) hospitalizations. The HD days were not counted as hospitalizations, even when performed overnight.

Number of Days of Hospitalization Per Year

The number of days of hospitalizations per year was calculated as the sum of the durations of all non-HD hospitalizations in days (Date of discharge - Date of admission + 1)] / (duration of efficacy emergent period in days / 365.25). In case of missing dates, the hospitalization duration was imputed by the average duration per stay derived from the participants with non-missing duration within the same treatment group.

Time to First Hospitalization

Time to first hospitalization in years was defined in years as: (First event date during the Efficacy Emergent Period - Analysis date of First dose intake +1)/365.25, and the 'First event date' was defined as 'Date of first Admission and 'Analysis Date of first dose intake. For participants without hospitalization, the time to censoring was calculated as: (Date of End of Efficacy Emergent Period - Analysis Date of first dose intake + 1) / 365.25. Date of End of Efficacy Emergent Period was defined as as the treatment period up to the EOT visit. For participants who have experienced more than one hospitalization, only their first event following study treatment was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula.

Time to First Use of Rescue Therapy

Rescue therapy was defined as red blood cell (RBC) transfusion for both treatment groups and ESA for roxadustat participants. Only rescue medication that was started during the study treatment and up to end of efficacy emergent period was taken into account and considered as use of rescue medication. For participants who have experienced more than one use of rescue therapy, only their first event following study treatment was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula.

Time to First RBC Transfusion

For participants who have experienced more than one RBC transfusion, only their first event following study treatment was used. For RBC transfusions, when the number of units was not given but the volume transfused was, the number of units were estimated by volume transfused/250 mL (for transfusion of packed cell units) or volume transfused/500 mL (for transfusion of full blood). Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula.

Mean Monthly Number of RBC Packs Per Participant

During efficacy emergent period, the mean monthly number of RBC packs was calculated as the sum of blood volume and units transfused between the first dose and up to the last dose in the period divided by duration of efficacy emergent period (in days) divided by 28 days. Participants without medication records of RBC have their number of RBC packs and volume set to 0.

Mean Monthly Volume of RBC Transfusion Per Participant

During Efficacy Emergent Period, the mean monthly volume of blood transfused was calculated as the sum of blood volume and units transfused between the first dose and up to the last dose in the period divided by duration of efficacy emergent period (in days) divided by 28 days. The Efficacy Emergent Period was defined as the evaluation period from the Analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period).

Time to First Use of IV Iron Supplementation

For participants who have received more than one IV iron, only their first event following study treatment was used. Data reported was analyzed by Kaplan-Meier estimate for cumulative proportion and the 95% confidence interval was calculated with Greenwood's formula.

Mean Monthly Intravenous (IV) Iron Per Participant During Weeks 37-52 and Weeks 53-104

Participants with no or missing medication records of IV Iron had their monthly IV Iron use set to 0 mg.

Percentage of Participants With Oral Iron Use Only

Percentage of participants with/without IV iron only was calculated based on total number of participants within the Efficacy Emergent Period. The Efficacy Emergent Period is defined as the evaluation period from the Analysis date of first dose intake up to EOT Visit or last non-missing Hb assessment (for participants who died during the treatment period).

Change From BL to Each Post-dosing Study Visit in Total Cholesterol

Baseline assessment was the assessment from Day 1 visit. If baseline value was missing, then the latest screening period value was used as the baseline regardless of fasting status.

Change From BL to Each Post-dosing Study Visit in LDL-C/High-density Lipoprotein Cholesterol (HDL-C) Ratio

Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting.

Change From BL to Each Postdosing Study Visit in Non-HDL Cholesterol

Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting.

Change From BL to Each Postdosing Study Visit in Apolipoproteins A1 (ApoA1)

Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting.

Change From BL to Each Postdosing Study Visit in Apolipoproteins B (ApoB)

Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting.

Change From BL to Each Postdosing Study Visit in ApoB/ApoA1 Ratio

Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used.

Number of Participants With Mean LDL Cholesterol < 100 mg/dL Over Weeks 12 to 28

Missing category for Fasting Only includes non-fasting participants and the participants with missing values.

Number of Participants With CKD Who Achieved Antihypertensive Treatment Goal

Achieved antihypertensive treatment goal was defined as SBP < 140 mmHg and DBP < 90 mmHg over an evaluation period based on the average of available values in weeks 12-28 (pre-dialysis).

Change From BL to the Average of Weeks 12 to 28 in SF-36 Physical Component Score (PCS)

Baseline SF-36 PCS was defined as the SF-36 PCS value on Day 1. SF-36 contains 36-item that measures 8 scales with scores ranging from 0-100: physical functioning (PF); role limitations due to physical health problems (RP); bodily pain (BP); social functioning (SF); general health perceptions (GH); role limitations due to emotional problems (RE); vitality, energy or fatigue (VT); and mental health (MH). These scores are normed to the US population (norm-based scoring had very little impact on results when data was collected in Western European countries) to have a mean of 50 and standard deviation of 10. The PCS was calculated based on all 8 scales and ranges from 5.02-79.78. For each of these above scales, higher scores always indicating better health status.

Change From BL to the Average of Weeks 12 to 28 in Anemia Subscale (AnS) ("Additional Concerns") of Functional Assessment of Cancer Therapy-Anemia (FACT-An) Score

Baseline FACT-An AnS was defined as the FACT-An AnS value on Day 1. Together with the Functional Assessment of Cancer Therapy - General (FACT-G), the Anemia Subscale (AnS) is referred to as the FACT-An Total. The AnS scale contains 13 fatigue specific items (the Fatigue Score) plus 7 items related to anemia. The Anemia AnS score range is 0 to 80. For the above score, a higher score indicates better QoL.

Change From BL to the Average Value of Weeks 12 to 28 in Total FACT-An Score

Baseline FACT-An Total Score was defined on Day 1. Total Fact-An score is composed of FACT-G and Ans scales. FACT-G contains 27 items that cover four dimensions of well-being: physical (PWB) - 7 items, functional (FWB) - 7 items, social/family (SWB) - 7 items, and emotional (EWB) - 6 items. The AnS scale contains 13 fatigue specific items (the Fatigue Score) plus 7 items related to anemia. The total score is obtained by summation of the scores from PWB, SWB, EWB, FWB and AnS. The FACT-An Total Score scale range is 0-188. A higher score indicates better QoL.

Change From BL to the Average of Weeks 12 to 28 in Euroqol Questionnaire-5 Dimensions 5 Levels (EQ-5D 5L) Visual Analogue Scale (VAS) Score

Baseline assessment was defined as the value on Day 1. The EuroQol Questionnaire -5 Dimensions -5 Levels (EQ-5D-5L) is a self-reported questionnaire, used as a measure of respondents' Health Related Quality of Life (HRQoL) and utility values. The EQ-5D consists of the descriptive system and the visual analogue scale (VAS). The EQ-5D descriptive system comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, extreme problems. The VAS records the respondent's self rated health status on a graduated (0-100) scale, where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state' with higher scores for higher HRQoL.

Percentage of Participants With Improvements Measured by Patients' Global Impression of Change (PGIC)

The PGIC is a patient-rated instrument that measures change in participant's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), when compared to the start of treatment. The percentage of participants presented includes very much improved, much improved and minimally improved.

Change From BL in Serum Hepcidin

Baseline assessment was assessment from Day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied.

Change From BL in Serum Ferritin

Baseline assessment was assessment from Day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied.

Change From BL in Transferrin Saturation (TSAT)

Baseline assessment was assessment from Day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied.

Change From BL in Glycated Hemoglobin (HbA1c) Level to Weeks 12, 28, 36, 44, 52, 60, 84, 104 and EOS (up to Week 108)

Percentage of change from baseline to each study visit were calculated for HbA1c. Baseline assessment was assessment from Day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Safety was assessed by evaluation of the following variables: (TEAEs; frequency, severity, seriousness, and relationship to study drug), Vital signs (systolic and diastolic blood pressure, pulse, respiratory rate and weight), Clinical laboratory variables (hematology, biochemistry including liver enzymes and total bilirubin, and urinalysis), Physical examination, 12-lead electrocardiogram (ECG) and Vascular Access Thrombosis. All AEs collected during the Safety Emergent Period were counted as TEAE. The TEAE was defined as an adverse event (AE) if it was observed after starting administration of the roxadustat or ESA. Any clinically significant abnormalities were reported as an AEs. All reported deaths after the first study drug administration and up to 28 days after the Analysis Date of Last Dose and considering last dosing frequency.

Full Information

NCT ID

NCT02278341

First Posted

October 28, 2014

Last Updated

January 14, 2021

Sponsor

Astellas Pharma Europe B.V.

Collaborators

FibroGen

1. Study Identification

Unique Protocol Identification Number

NCT02278341

Brief Title

Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis

Acronym

Pyrenees

Official 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 Patients on Stable Dialysis

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

November 21, 2014 (Actual)

Primary Completion Date

June 8, 2017 (Actual)

Study Completion Date

July 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Europe B.V.

Collaborators

FibroGen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study was conducted to explore a new therapy for anemia in participants with end stage renal disease (ESRD) on dialysis. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin (which contains iron) is important for the transport of oxygen in your blood. The purpose of this study was to evaluate if roxadustat is effective and safe in the maintenance treatment of anemia in ESRD participants on stable dialysis. Roxadustat was compared to epoetin alfa and darbepoetin alfa, commercially available medicines for treatment of anemia.

Detailed Description

This study consisted of three study periods as follows: Screening Period: up to 6 weeks Treatment Period: a minimum of 52 weeks up to a maximum of 104 weeks Follow-up Period: 4 weeks

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia, End Stage Renal Disease (ESRD)

Keywords

ASP1517, FG-4592, Anemia, End Stage Renal Disease (ESRD), Erythropoetin Stimulating Agents (ESAs), Chronic Kidney Disease, Hematopoetic Agents, HIF-PH inhibitor, Hemoglobin, Dialysis, roxadustat

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

838 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Roxadustat

Arm Type

Experimental

Arm Description

Arm Title

ESA (Erythropoiesis Stimulating Agent) treatment

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Roxadustat

Other Intervention Name(s)

ASP1517, FG-4592

Intervention Description

Participants received initial dose of roxadustat orally as a tablet in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.

Intervention Type

Drug

Intervention Name(s)

Epoetin alfa

Other Intervention Name(s)

Eprex

Intervention Description

Participants received epoetin alfa via intravenous or subcutaneous injection, once a week, twice a week, or three times a week (TIW). Epoetin alfa dosage was adjusted to maintain Hb level within the target range. Dosing of epoetin alfa was per UK SmPC of Eprex®. Participants received IV iron supplementation according to the standard of care.

Intervention Type

Drug

Intervention Name(s)

Darbepoetin alfa

Other Intervention Name(s)

Aranesp

Intervention Description

Participants received darbepoetin alfa via intravenous or subcutaneous injection, once a week or once every other week. Darbepoetin alfa dosage was adjusted to maintain Hb level within the target range. Dosing of darbepoetin alfa was per EU SmPC of Aranesp®. Participants received IV iron supplementation according to the standard of care.

Intervention Type

Drug

Intervention Name(s)

Iron

Intervention Description

Oral iron treatment was recommended for supplementation to support erythropoiesis and as first-line treatment for iron deficiency, unless participant was intolerant to this treatment. For participants receiving roxadustat the recommended daily dose was 200 mg of elemental iron. Participants were advised to take roxadustat at least 1 hour before or 1 hour after oral iron. Intravenous iron supplementation for participants receiving roxadustat was allowed if all of the following criteria were met: The participant's Hb level had not responded adequately to roxadustat following two consecutive dose increases or reached the maximum dose limit, and participant's ferritin was < 100 ng/mL (< 220 pmol/L) or TSAT < 20%, or the participant was intolerant of oral iron therapy. For participants treated with epoetin alfa or darbepoetin alfa, IV iron supplementation was given according to standard of care.

Primary Outcome Measure Information:

Title

Change From Baseline (BL) to the Average Hemoglobin (Hb) in Weeks 28-36 Without Rescue Therapy [EU (EMA)]

Description

Time Frame

Baseline and weeks 28 to 36

Title

Change From BL to the Average Hb in Weeks 28 to 52 Regardless of Rescue Therapy [US (FDA)]

Description

Time Frame

Baseline and weeks 28 to 52

Secondary Outcome Measure Information:

Title

Percentage of Participants With Hb Response During Weeks 28 to 36

Description

Time Frame

Weeks 28 to 36

Title

Change From BL in Low Density Lipoprotein Cholesterol (LDL-C) to the Average LDL-C of Weeks 12 to 28

Description

Baseline LDL was defined as the LDL value on Day 1. If this value was missing, the latest value prior to first study drug administration was used.

Time Frame

Baseline and weeks 12 to 28

Title

Mean Monthly Intravenous (IV) Iron Use

Description

Time Frame

Day 1 to week 36

Title

Change From BL in Short Form-36 (SF-36) Health Survey Physical Functioning (PF) Sub-score to the Average of Weeks 12 to 28

Description

Time Frame

Baseline and weeks 12 to 28

Title

Change From BL in SF-36 Vitality (VT) Sub-score to the Average of Weeks 12 to 28

Description

Time Frame

Baseline and weeks 12 to 28

Title

Change From BL in Mean Arterial Pressure (MAP) to the Average of Weeks 20 to 28

Description

Time Frame

Baseline and weeks 20 to 28

Title

Time to First Occurrence of an Increase in Blood Pressure

Description

Time Frame

Weeks 1 to 36

Title

Change From BL in Mean Arterial Pressure (MAP) to the Average MAP Value of Weeks 20 to 28

Description

Time Frame

Baseline and weeks 20 to 28

Title

Time to First Occurrence of an Increase in Blood Pressure

Description

Time Frame

Weeks 1 to 36

Title

Percentage of Participants With a Hb Response During Weeks 28 and 36 Regardless of Use of Rescue Therapy

Description

Time Frame

Weeks 28 to 36

Title

Change From BL in Hb to Each Postdosing Time Point

Description

Baseline Hb was defined as the mean of four latest central laboratory Hb values prior or on the same date as first study drug intake (pre-dose).

Time Frame

Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 16, 18,20, 22, 24, 26, 28, 30, 32, 34, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72,76, 80, 84, 88, 92, 96, 100, and 104

Title

Hb Level Averaged Over Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy

Description

Time Frame

Weeks 28 to 36, 44 to 52, and 96 to 104

Title

Change From BL in Hb to the Average of Weeks 28 to 36, 44 to 52, and 96 to 104 Regardless of the Use of Rescue Therapy

Description

Time Frame

Baseline and weeks 28 to 36, 44 to 52, and 96 to 104

Title

Percentage of Hb Values ≥ 10 g/dL in Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy

Description

Time Frame

Weeks 28-36, 44-52 and 96-104

Title

Percentage of Hb Values Within 10.0 to 12.0 g/dL in Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy

Description

Time Frame

Weeks 28-36, 44-52 and 96-104

Title

Number of Hospitalizations

Description

Time Frame

Baseline to End of Treatment (EOT) (Up to week 104)

Title

Number of Days of Hospitalization Per Year

Description

Time Frame

Baseline to EOT (Up to week 104)

Title

Time to First Hospitalization

Description

Time Frame

Baseline to EOT (Up to week 104)

Title

Time to First Use of Rescue Therapy

Description

Time Frame

Baseline to EOT (Up to week 104)

Title

Time to First RBC Transfusion

Description

Time Frame

Baseline to EOT (Up to week 104)

Title

Mean Monthly Number of RBC Packs Per Participant

Description

Time Frame

Baseline to EOT (Up to week 104)

Title

Mean Monthly Volume of RBC Transfusion Per Participant

Description

Time Frame

Baseline to EOT (Up to week 104)

Title

Time to First Use of IV Iron Supplementation

Description

Time Frame

Baseline to EOT (Up to week 104)

Title

Mean Monthly Intravenous (IV) Iron Per Participant During Weeks 37-52 and Weeks 53-104

Description

Participants with no or missing medication records of IV Iron had their monthly IV Iron use set to 0 mg.

Time Frame

Weeks 37-52 and weeks 53-104

Title

Percentage of Participants With Oral Iron Use Only

Description

Time Frame

Baseline to EOT (Up to week 104)

Title

Change From BL to Each Post-dosing Study Visit in Total Cholesterol

Description

Baseline assessment was the assessment from Day 1 visit. If baseline value was missing, then the latest screening period value was used as the baseline regardless of fasting status.

Time Frame

Baseline and weeks 8, 28, 52, 104

Title

Change From BL to Each Post-dosing Study Visit in LDL-C/High-density Lipoprotein Cholesterol (HDL-C) Ratio

Description

Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting.

Time Frame

Baseline and weeks 8, 28, 52, 104

Title

Change From BL to Each Postdosing Study Visit in Non-HDL Cholesterol

Description

Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting.

Time Frame

Baseline and weeks 8, 28, 52, 104

Title

Change From BL to Each Postdosing Study Visit in Apolipoproteins A1 (ApoA1)

Description

Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting.

Time Frame

Baseline and weeks 8, 28, 52, 104

Title

Change From BL to Each Postdosing Study Visit in Apolipoproteins B (ApoB)

Description

Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used regardless of fasting.

Time Frame

Baseline and weeks 8, 28, 52, 104

Title

Change From BL to Each Postdosing Study Visit in ApoB/ApoA1 Ratio

Description

Baseline was defined as the value on Day 1. If baseline value was missing, the latest value prior to first study drug administration was used.

Time Frame

Baseline and weeks 8, 28, 52, 104

Title

Number of Participants With Mean LDL Cholesterol < 100 mg/dL Over Weeks 12 to 28

Description

Missing category for Fasting Only includes non-fasting participants and the participants with missing values.

Time Frame

Weeks 12 to 28

Title

Number of Participants With CKD Who Achieved Antihypertensive Treatment Goal

Description

Achieved antihypertensive treatment goal was defined as SBP < 140 mmHg and DBP < 90 mmHg over an evaluation period based on the average of available values in weeks 12-28 (pre-dialysis).

Time Frame

Weeks 12 to 28

Title

Change From BL to the Average of Weeks 12 to 28 in SF-36 Physical Component Score (PCS)

Description

Time Frame

Baseline and weeks 12 to 28

Title

Change From BL to the Average of Weeks 12 to 28 in Anemia Subscale (AnS) ("Additional Concerns") of Functional Assessment of Cancer Therapy-Anemia (FACT-An) Score

Description

Time Frame

Baseline and weeks 12 to 28

Title

Change From BL to the Average Value of Weeks 12 to 28 in Total FACT-An Score

Description

Time Frame

Baseline and weeks 12 to 28

Title

Change From BL to the Average of Weeks 12 to 28 in Euroqol Questionnaire-5 Dimensions 5 Levels (EQ-5D 5L) Visual Analogue Scale (VAS) Score

Description

Time Frame

Baseline and weeks 12 to 28

Title

Percentage of Participants With Improvements Measured by Patients' Global Impression of Change (PGIC)

Description

Time Frame

Baseline and weeks 8, 12, 28, 36, 52, 76, 104

Title

Change From BL in Serum Hepcidin

Description

Baseline assessment was assessment from Day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied.

Time Frame

Baseline and weeks 4, 12, 20, 36, 52, 104, and End of Study (EOS - up to 108 weeks)

Title

Change From BL in Serum Ferritin

Description

Baseline assessment was assessment from Day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied.

Time Frame

Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104, and EOS (up to 108 weeks)

Title

Change From BL in Transferrin Saturation (TSAT)

Description

Baseline assessment was assessment from Day 1 visit. If baseline value was missing, the value from screening visit was used. In case of missing data, no imputation rules were applied.

Time Frame

Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104 and EOS (up to 108 weeks)

Title

Change From BL in Glycated Hemoglobin (HbA1c) Level to Weeks 12, 28, 36, 44, 52, 60, 84, 104 and EOS (up to Week 108)

Description

Time Frame

Baseline and weeks 12, 28, 36, 44, 52, 60, 84, 104 and EOS (up to 108 weeks)

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Description

Time Frame

Baseline up to EOS (Up to week 108)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Main Inclusion: Participant is on stable hemodialysis (HD), hemodiafiltration (HDF) or peritoneal dialysis (PD) treatment with the same mode of dialysis for ≥4 months prior to randomization. Participant is on IV or SC epoetin or IV or SC darbepoetin alfa treatment for ≥8 weeks prior to randomization with stable weekly doses (during 4 weeks prior to randomization). Mean of the participant's three most recent Hb values, as measured by central laboratory, during the Screening Period. Participant'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 Exclusion Criteria: Main Exclusion: Participant has received a red blood cell (RBC) transfusion within 8 weeks prior to randomization. Participant 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). Participant 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. Participant has had uncontrolled hypertension, in the opinion of the investigator, within 2 weeks prior to randomization. Participant 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. Participant has had any prior organ transplant (that has not been explanted), or participant is scheduled for organ transplantation.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Physician

Organizational Affiliation

Astellas Pharma Europe B.V.

Official's Role

Study Director

Facility Information:

Facility Name

Site BE32004

City

Brussels

State/Province

Flemish Brabant

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Site BE32001

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

Site BE32019

City

Antwerpen

ZIP/Postal Code

2020

Country

Belgium

Facility Name

Site BE32002

City

Antwerp

ZIP/Postal Code

2060

Country

Belgium

Facility Name

Site BE32012

City

Baudour

ZIP/Postal Code

7331

Country

Belgium

Facility Name

Site BE32017

City

Bonheiden

ZIP/Postal Code

2820

Country

Belgium

Facility Name

Site BE32003

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Site BE32013

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Site BE32011

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

Site BG35925

City

Blagoevgrad

ZIP/Postal Code

2700

Country

Bulgaria

Facility Name

Site BG35931

City

Haskovo

ZIP/Postal Code

6300

Country

Bulgaria

Facility Name

Site BG35915

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Site BG35909

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Site BG35919

City

Plovdiv

ZIP/Postal Code

4003

Country

Bulgaria

Facility Name

Site BG35920

City

Rousse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

Site BG35938

City

Shumen

ZIP/Postal Code

9700

Country

Bulgaria

Facility Name

Site BG35924

City

Sofia

ZIP/Postal Code

1309

Country

Bulgaria

Facility Name

Site BG35906

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Site BG35921

City

Sofia

ZIP/Postal Code

1527

Country

Bulgaria

Facility Name

Site BG35907

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Site BG35916

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Site BG35918

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Site BG35903

City

Veliko Tarnovo

ZIP/Postal Code

5000

Country

Bulgaria

Facility Name

Site BG35937

City

Yambol

ZIP/Postal Code

8600

Country

Bulgaria

Facility Name

Site HR38509

City

Zagreb

State/Province

Grad Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Site HR38508

City

Cakovec

ZIP/Postal Code

40000

Country

Croatia

Facility Name

Site HR38505

City

Karlovac

ZIP/Postal Code

47000

Country

Croatia

Facility Name

Site HR38507

City

Osijek

ZIP/Postal Code

31 000

Country

Croatia

Facility Name

Site HR38506

City

Rijeka

ZIP/Postal Code

51000

Country

Croatia

Facility Name

Site HR38504

City

Slavonski Brod

ZIP/Postal Code

35000

Country

Croatia

Facility Name

Site HR38501

City

Zadar

ZIP/Postal Code

23 000

Country

Croatia

Facility Name

Site CZ42008

City

Liberec

ZIP/Postal Code

46063

Country

Czechia

Facility Name

Site CZ42021

City

Praha 6

ZIP/Postal Code

169 00

Country

Czechia

Facility Name

Site CZ42015

City

Rakovnik

ZIP/Postal Code

26929

Country

Czechia

Facility Name

Site FR33005

City

Amiens cedex 1

ZIP/Postal Code

80054

Country

France

Facility Name

Site FR33010

City

La Tronche

ZIP/Postal Code

38701

Country

France

Facility Name

Site FR33055

City

Saint Ouen

ZIP/Postal Code

93400

Country

France

Facility Name

Site FR33007

City

Saint Priez En Jarez

ZIP/Postal Code

42270

Country

France

Facility Name

Site FR33056

City

Valenciennes

ZIP/Postal Code

59300

Country

France

Facility Name

Site GE99503

City

Tbilisi

ZIP/Postal Code

0144

Country

Georgia

Facility Name

Site GE99504

City

Tbilisi

ZIP/Postal Code

0144

Country

Georgia

Facility Name

Site GE99508

City

Tbilisi

ZIP/Postal Code

159

Country

Georgia

Facility Name

Site DE49056

City

Dormagen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

41540

Country

Germany

Facility Name

Site DE49067

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Site DE49073

City

Cloppenburg

ZIP/Postal Code

49661

Country

Germany

Facility Name

Site DE49008

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Site DE49054

City

Dusseldorf

ZIP/Postal Code

40210

Country

Germany

Facility Name

Site DE49020

City

Frankfurt am Main

ZIP/Postal Code

60590

Country

Germany

Facility Name

Site DE49065

City

Hamburg

ZIP/Postal Code

23397

Country

Germany

Facility Name

Site DE49075

City

Heilbronn

ZIP/Postal Code

74076

Country

Germany

Facility Name

Site DE49001

City

Kaiserslautern

ZIP/Postal Code

67655

Country

Germany

Facility Name

Site DE49070

City

Muenchen

ZIP/Postal Code

81695

Country

Germany

Facility Name

Site DE49002

City

Solingen

ZIP/Postal Code

42653

Country

Germany

Facility Name

Site DE49071

City

Villingen-Schwenningen

ZIP/Postal Code

78052

Country

Germany

Facility Name

Site HU36033

City

Baja

ZIP/Postal Code

6500

Country

Hungary

Facility Name

Site HU36036

City

Esztergom

ZIP/Postal Code

2500

Country

Hungary

Facility Name

Site HU36031

City

Gyor

ZIP/Postal Code

9002

Country

Hungary

Facility Name

Site HU36026

City

Kaposvar

ZIP/Postal Code

H 7400

Country

Hungary

Facility Name

Site HU36027

City

Kistarcsa

ZIP/Postal Code

2143

Country

Hungary

Facility Name

Site HU36032

City

Pecs

ZIP/Postal Code

7624

Country

Hungary

Facility Name

Site HU36035

City

Pecs

ZIP/Postal Code

7633

Country

Hungary

Facility Name

Site HU36034

City

Salgotarjan

ZIP/Postal Code

3100

Country

Hungary

Facility Name

Site HU36004

City

Szeged

ZIP/Postal Code

6724

Country

Hungary

Facility Name

Site HU36046

City

Szekesfehervar

ZIP/Postal Code

8000

Country

Hungary

Facility Name

Site HU36006

City

Szombathely

ZIP/Postal Code

H 9700

Country

Hungary

Facility Name

Site HU36003

City

Zalsaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Site IT39028

City

Prato

State/Province

Frazione Di Galciana

ZIP/Postal Code

59100

Country

Italy

Facility Name

Site IT39039

City

Cremona

State/Province

Lombardia

ZIP/Postal Code

26100

Country

Italy

Facility Name

Site IT39014

City

Mestre

State/Province

Venezia

ZIP/Postal Code

30174

Country

Italy

Facility Name

Site IT39010

City

Brescia

ZIP/Postal Code

25123

Country

Italy

Facility Name

Site IT39008

City

Lecco

ZIP/Postal Code

23900

Country

Italy

Facility Name

Site IT39006

City

Milano

ZIP/Postal Code

20162

Country

Italy

Facility Name

Site IT39037

City

Modena

ZIP/Postal Code

41124

Country

Italy

Facility Name

Site IT39022

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Site IT39036

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Site IT39005

City

Roma

ZIP/Postal Code

122

Country

Italy

Facility Name

Site IT39035

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Site IT39032

City

Trieste

ZIP/Postal Code

34142

Country

Italy

Facility Name

Site PL48002

City

Katowice

ZIP/Postal Code

40 027

Country

Poland

Facility Name

Site PL48001

City

Krakow

ZIP/Postal Code

30 501

Country

Poland

Facility Name

Site PL48013

City

Szczecin

ZIP/Postal Code

70-111

Country

Poland

Facility Name

Site PL48005

City

Warszawa

ZIP/Postal Code

00 507

Country

Poland

Facility Name

Site PL48006

City

Wroclaw

ZIP/Postal Code

50-556

Country

Poland

Facility Name

Site PL48009

City

Wroclaw

ZIP/Postal Code

51 124

Country

Poland

Facility Name

Site PL48014

City

Zamosc

ZIP/Postal Code

20-400

Country

Poland

Facility Name

Site PT35121

City

Almada

ZIP/Postal Code

2800-455

Country

Portugal

Facility Name

Site PT35127

City

Aveiro

ZIP/Postal Code

3800-266

Country

Portugal

Facility Name

Site PT35139

City

Cascais

ZIP/Postal Code

2750-663

Country

Portugal

Facility Name

Site PT35117

City

Faro

ZIP/Postal Code

8005-546

Country

Portugal

Facility Name

Site PT35128

City

Gaeiras

ZIP/Postal Code

2510-702

Country

Portugal

Facility Name

Site PT35114

City

Leiria

ZIP/Postal Code

2400-441

Country

Portugal

Facility Name

Site PT35102

City

Porto

ZIP/Postal Code

4099-001

Country

Portugal

Facility Name

Site PT35122

City

Setubal

ZIP/Postal Code

2900-655

Country

Portugal

Facility Name

Site RO40018

City

Bucharest

ZIP/Postal Code

011794

Country

Romania

Facility Name

Site RO40015

City

Bucharest

Country

Romania

Facility Name

Site RO40019

City

Bucharest

Country

Romania

Facility Name

Site RO40003

City

Bucuresti

ZIP/Postal Code

22328

Country

Romania

Facility Name

Site RO40004

City

Oradea

ZIP/Postal Code

410562

Country

Romania

Facility Name

Site RU70008

City

Kaluga

ZIP/Postal Code

248007

Country

Russian Federation

Facility Name

Site RU70051

City

Moscow

ZIP/Postal Code

119992

Country

Russian Federation

Facility Name

Site RU70005

City

Moscow

ZIP/Postal Code

125284

Country

Russian Federation

Facility Name

Site RU70003

City

Nizhny Novgorod

ZIP/Postal Code

603032

Country

Russian Federation

Facility Name

Site RU70004

City

Omsk

ZIP/Postal Code

644112

Country

Russian Federation

Facility Name

Site RU70014

City

Rostov-on-Don

ZIP/Postal Code

344029

Country

Russian Federation

Facility Name

Site RU70072

City

Saint Petersburg

ZIP/Postal Code

190103

Country

Russian Federation

Facility Name

Site RU70002

City

Saint Petersburg

ZIP/Postal Code

197089

Country

Russian Federation

Facility Name

Site RU70011

City

Saint-Petersburg

ZIP/Postal Code

196247

Country

Russian Federation

Facility Name

Site RU70050

City

Saint-Petersburg

ZIP/Postal Code

197374

Country

Russian Federation

Facility Name

Site RU70030

City

Sankt-Peterburg

ZIP/Postal Code

197110

Country

Russian Federation

Facility Name

Site RU70006

City

Smolensk

ZIP/Postal Code

214006

Country

Russian Federation

Facility Name

Site RU70037

City

Volgograd

ZIP/Postal Code

404120

Country

Russian Federation

Facility Name

Site RU70001

City

Yaroslavl

ZIP/Postal Code

150062

Country

Russian Federation

Facility Name

Site RS38102

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Site RS38105

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Site RS38120

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Site RS38104

City

Belgrade

Country

Serbia

Facility Name

Site RS38117

City

Krusevac

ZIP/Postal Code

37000

Country

Serbia

Facility Name

Site RS38101

City

Nis

Country

Serbia

Facility Name

Site RS38116

City

Zrenjanin

Country

Serbia

Facility Name

Site SK42102

City

Koshice

ZIP/Postal Code

04001

Country

Slovakia

Facility Name

Site SK42119

City

Levice

ZIP/Postal Code

93401

Country

Slovakia

Facility Name

Site SK42120

City

Lučenec

ZIP/Postal Code

984 01

Country

Slovakia

Facility Name

Site SK42113

City

Puchov

ZIP/Postal Code

020 01

Country

Slovakia

Facility Name

Site SK42116

City

Senica

ZIP/Postal Code

90501

Country

Slovakia

Facility Name

Site ES34041

City

Santiago de Compostela

State/Province

A Coruna

ZIP/Postal Code

15706

Country

Spain

Facility Name

Site ES34009

City

El Ejido

State/Province

Almeria

ZIP/Postal Code

04700

Country

Spain

Facility Name

Site ES34010

City

Alcorcon

State/Province

Madrid

ZIP/Postal Code

28922

Country

Spain

Facility Name

Site ES34030

City

Majadahonda

State/Province

Madrid

ZIP/Postal Code

28222

Country

Spain

Facility Name

Site ES34011

City

Galdakao

State/Province

Vizcaya

ZIP/Postal Code

48960

Country

Spain

Facility Name

Site ES34002

City

Badalona-Barcelona

ZIP/Postal Code

8916

Country

Spain

Facility Name

Site ES34008

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Site ES34006

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Site ES34017

City

Jaen

ZIP/Postal Code

23007

Country

Spain

Facility Name

Site ES34037

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Site ES34052

City

Valencia

ZIP/Postal Code

46017

Country

Spain

Facility Name

Site GB44087

City

Brighton

State/Province

EastSussex

ZIP/Postal Code

BN2 5BD

Country

United Kingdom

Facility Name

Site GB44011

City

Canterbury

State/Province

Kent

ZIP/Postal Code

CT1 3NG

Country

United Kingdom

Facility Name

Site GB44080

City

Stoke on Trent

State/Province

Staffordshire

ZIP/Postal Code

ST4 6QG

Country

United Kingdom

Facility Name

Site GB44008

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Site GB44010

City

Hull

ZIP/Postal Code

HU3 2JZ

Country

United Kingdom

Facility Name

Site GB44081

City

Leicester

ZIP/Postal Code

LE5 4PW

Country

United Kingdom

Facility Name

Site GB44079

City

Liverpool

ZIP/Postal Code

L9 7AL

Country

United Kingdom

Facility Name

Site GB44001

City

Swansea

ZIP/Postal Code

SA6 6NL

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

IPD Sharing Time Frame

Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.

IPD Sharing Access Criteria

Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

IPD Sharing URL

https://www.clinicalstudydatarequest.com/

Citations:

PubMed Identifier

36005278

Citation

Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

Results Reference

derived

Links:

URL

https://astellasclinicalstudyresults.com/study.aspx?ID=364

Description

Link to results on Astellas Clinical Study Results website

Learn more about this trial

Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis

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Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis (Pyrenees)

Anemia, End Stage Renal Disease (ESRD)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial