The multi-purpose, short-form health survey has 36 questions with an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures. The total score is obtained by summation of the scores from PWB, SWB, EWB, FWB and AnS. Change from baseline in PF sub score of SF-36 to the average of weeks 12-28 was compared by treatment arm for all participants (primary analysis) and in the subsets of participants with baseline PF sub score below 35 and equal or above 35. The last Hb value must be within 10 days prior to randomization. Participant has a serum vitamin B12 level greater than or equal to lower limit of normal at screening. Enrollment was completed in the WHITNEY US Phase 2 roxadustat clinical trial in chemotherapy-induced anemia (CIA) in 4Q 2020. Participant has an active clinically significant infection manifested by White Blood Count (WBC) > ULN, and/or fever, in conjunction with clinical signs or symptoms of infection within one week prior to randomization. Data analysis was completed using Kaplan-Meier estimate for cumulative proportion. (NCT02021318) study is a phase III clinical trial which is currently active with an estimated enrollment of approximately 600 participants (Table 2). AstraZeneca in CVRM Fibrogen has a lot riding on pivotal data for roxadustat, its project for anaemia in chronic kidney disease. Patients were given roxadustat twice weekly or TIW in doses ranging from 0.7 and 2.0 mg/kg. Individual Participant Data (IPD) Sharing Statement: 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. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to 7 days after the analysis date of last dose or EOT visit, whichever occured first. Tokyo-based Astellas Pharma announced that its roxadustat met its primary endpoints in the Phase III ALPS clinical trial in chronic kidney disease (CKD) patients with anemia not on dialysis. Changes from baseline to each timepoint were reported in unit 'fraction of 1'. Participants without any blood pressure measurement were excluded. The First event date was defined as First occurrence of 40% decrease in eGFR from baseline, first occurrence of chronic dialysis or renal transplant (whichever occurred first and Analysis date of first dose intake was defined as date of first study drug dose intake collected on day 1 visit. Oncology decisions ahead for the FDA, More patience needed for novel anaemia class’s biggest test. Data analysis was completed using Kaplan-Meier estimate for cumulative proportion. No estimation if values were missing. Occurrence of hypertension was defined as SBP increase from BL ≥20 mmHg and SBP >170 mmHg or DBP increase from BL ≥15 mmHg and DBP ≥110 mmHg. Time to event was defined as (First event date - Analysis date of first dose intake + 1) / 365.25. The efficacy and safety of roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, have been demonstrated in the pivotal Phase III programme including more than 8,000 patients and published in five peer-reviewed journals. The multi-purpose, short-form health survey has 36 questions with an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures. HIF causes the physiological response to low oxygen conditions. HIMALAYAS evaluated roxadustat compared to epoetin alfa in incident dialysis (ID) patients; there were ID patients in ROCKIES and SIERRAS. If the value was missing, the latest value prior to first study drug administration was used. If this value was missing, the latest value prior to first study drug administration was used. HIF-PH inhibitors like roxadustat are designed to stabilise the HIF complex and stimulate endogenous erythropoietin production, effectively mimicking the body’s reaction to high altitude. Dose-titration was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. The number of days of hospitalization per PEY was calculated as the sum of the durations of all hospitalizations in days [Minimum (Date of discharge, End of Efficacy Emergent Period) - Date of admission + 1] / [Duration of Efficacy Emergent Period in days / 365.25]. The endpoint was defined as time to doubling serum creatinine or chronic dialysis or renal transplant what ever came first. The AnS scale contains 13 fatigue specific items (the Fatigue Score) plus 7 items related to anemia. The SF-36 scores ranged from 0-100 with higher scores indicating better health status. For participants with use of ESA, the time to first use of ESA was calculated as (First event date - Analysis date of first dose intake + 1) / 365.25. Baseline was defined as the value on day 1. To compute the geometric mean of albumin/creatinine ratio in urine and associated 95% CI, the mean of log-transformed albumin/creatinine ratio in urine values (ratio) and associated 95% CI are back-transformed to the raw scale. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Read our, ClinicalTrials.gov Identifier: NCT01887600, Interventional Participants without any LDL value within this duration were excluded. Uncontrolled hypertension or two or more blood pressure (BP) values of systolic BP (SBP) greater than or equal to 160 mmHg or diastolic BP (DBP) greater than or equal to 95 mmHg confirmed by repeat measurement within 2 weeks prior to randomization. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, extreme problems. Total Fact-An score is composed of FACT-G and Ans scales. The percentage of Hb values measured during weeks 96-104 within 10.0 -12.0 g/dL, without having received rescue therapy within 6 weeks prior to and during the 8-week evaluation period is reported. Fibrogen’s roxadustat has its first European win from the Alps trial, but the most important event is still to come. Two phase 3 European studies enrolled non–dialysis-dependent (NDD; ALPS) and dialysis-dependent (DD; PYRENEES) patients with CKD anemia. Astellas, which has partnered the project in Europe and Japan, did not give many details about the Alps study, except to say it had met its primary endpoints, haemoglobin response rate in the first 24 weeks and haemoglobin change from baseline at weeks 28 to 52. The data evaluated until the safety emergent period, which was defined as the evaluation period from analysis date of first drug intake up to 28 days after the analysis last dose, and results were presented for every 6 months up to 2 years. Initial data from the rest of the pivotal programme are expected by the end of the year, while a pooled safety analysis on major adverse cardiovascular events (MACE) is due in early 2019. Participant has had more than one dose of IV iron within 12 weeks prior to randomization. The change from baseline to the average Hb values across weeks 28 to 52 without having received rescue therapy. Baseline was defined as the value on day 1. The OLYMPUS, ALPS and ANDES trials evaluated roxadustat vs. placebo in NDD patients. The mean monthly volume transfused was calculated as the sum of the volume transfused between the first dose and up to the last dose in the period divided by duration (in days) and multiplied by 28 days. In case of missing number of packs, values were estimated based on 1 unit for packed cells = 250 mL or 1 unit for whole blood = 500 mL. The 36-Item short-form health survey (SF-36) is a multi-purpose survey with 36 questions. Participant has had a myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (e.g., pulmonary embolism) within 12 weeks prior to randomization. All available SF-36 PF values were used i.e., both scheduled and unscheduled for the calculation of the average PF sub-score of weeks 12 to 28. In case of missing data, no imputation rules were applied. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to 7 days after the analysis date of last dose or EOT visit, whichever occured first. Consistent with results from FibroGen's DD-CKD trials, roxadustat increased Hgb levels in a dose-dependent fashion, with faster responses in the TIW compared to twice weekly dosing groups. Roxadustat inhibits hypoxia inducible factor (HIF) prolyl hydroxylase activity. HIMALAYAS evaluated roxadustat compared to epoetin alfa in incident dialysis (ID) patients; there were ID patients in ROCKIES and SIERRAS. Baseline assessment was the assessment from day 1 visit. To evaluate the consistency of Hb increases across studies and global geographic regions, we analyzed data from three pivotal Phase 3 trials of roxadustat in patients with anemia and NDD-CKD. The current standard of care for anaemia in chronic kidney disease is erythropoiesis-stimulating agents (ESAs), synthetic versions of erythropoietin that spur the patient’s bone marrow to produce red blood cells. Participant has a history of chronic liver disease (e.g., cirrhosis or fibrosis of the liver). Data reported was analysed by Kaplan-Meier estimate for cumulative proportion. Oral iron was allowed in this study. 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-dosing). The Patients' Global Impression of Change (PGIC) is a participant-rated instrument that measures change in participants overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). 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-dosing). Participant's body weight is 45.0 kg up to a maximum of 160.0 kg. FibroGen and Astellas anticipate reporting high-level results from their remaining trials in due course. Data analysis was completed using Kaplan-Meier estimate for cumulative proportion. All eGFR values collected during the safety emergent period are considered, excluding those collected on or after initiation of dialysis (acute or chronic). For the above score, a higher score indicates better QoL. During efficacy emergent period, the mean monthly volume of blood transfused was calculated as the sum of blood volume 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. This should give Fibrogen and its partners a chance to make the most of their first-mover advantage – if they can get a good safety result. The global Phase III programme consists of more than 9,000 patients in trials conducted by AstraZeneca, FibroGen and Astellas. Akebia’s vadadustat and Glaxosmithkline’s daprodustat are also in phase III trials, but data are not due until the end of next year at the earliest. The physical component score was calculated based on the results of the SF-36 scores. https://www.clinicalstudydatarequest.com/, Treatment period: minimum 52 weeks (primary treatment period) up to a maximum of 104 weeks (extended treatment period), Percentage of Participants With a Hemoglobin (Hb) Response to Treatment at Two Consecutive Visits During the First 24 Weeks of Treatment Without Rescue Therapy Prior to Hb Response [ Time Frame: Baseline to week 24 ], Hb Change From Baseline (BL) to the Average Hb in Weeks 28-52 Regardless of Rescue Therapy [ Time Frame: Baseline and weeks 28 to 52 ], Hb Change From BL to the Average Hb in Weeks 28-36 Without Having Received Rescue Therapy Within 6 Weeks Prior to and During 8-Week Evaluation Period [ Time Frame: Baseline and weeks 28 to 36 ], Change From BL in Low-Density Lipoprotein (LDL) Cholesterol (Regardless of Fasting Status) to the Average LDL Cholesterol of Weeks 12 to 28 [ Time Frame: Baseline and weeks 12 to 28 ], Time to First Use of Rescue Therapy (Composite of Red Blood Cell (RBC) Transfusions, Erythropoiesis-stimulating Agent (ESA) Use, and Intravenous (IV) Iron) [ Time Frame: Baseline to week 104 (End of Treatment [EOT]) ], Change From BL in Short Form (SF)-36 Vitality (VT) Sub-score to the Average VT Sub-score of Weeks 12 to 28 [ Time Frame: Baseline and weeks 12 to 28 ], Change From BL in SF-36 Physical Functioning (PF) Sub-score to the Average PF Sub-score of Weeks 12 to 28 [ Time Frame: Baseline and weeks 12 to 28 ], Change From BL in Mean Arterial Pressure (MAP) to the Average MAP of Weeks 20 to 28 [ Time Frame: Baseline and weeks 20 to 28 ], Time to First Occurrence of Hypertension [ Time Frame: Baseline and year 0.5, year 1, year 1.5 and year 2 ], Rate of Progression of CKD Measured by Annualized Estimated Glomerular Filtration Rate (eGFR) Slope Over Time [ Time Frame: Baseline to week 108 ], Average Level of Hb Over Weeks 28 to 36 Without Use of Rescue Therapy Within 6 Weeks Prior to and During the Evaluation Period [ Time Frame: Weeks 28 to 36 ], Average Level of Hb Over Weeks 44 to 52 Without Use of Rescue Therapy Within 6 Weeks Prior to and During the Evaluation Period [ Time Frame: Weeks 44 to 52 ], Average Level of Hb Over Weeks 96 to 104 Without Use of Rescue Therapy Within 6 Weeks Prior to and During the Evaluation Period [ Time Frame: Weeks 96 to 104 ], Time to Achieve the First Hb Response Without Rescue Therapy, as Defined by Primary Endpoint [ Time Frame: Baseline to week 24 ], Hb Change From BL to Each Post-Dosing Time Point [ Time Frame: Baseline (day 1) and weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104 ], Hb Change From BL to the Average Hb Value of Weeks 28-36 Regardless of the Use of Rescue Therapy [ Time Frame: Baseline and weeks 28 to 36 ], Hb Change From BL to the Average Hb Value of Weeks 44-52 Regardless of the Use of Rescue Therapy [ Time Frame: Baseline and weeks 44 to 52 ], Hb Change From BL to the Average Hb Value of Weeks 96-104 Regardless of the Use of Rescue Therapy [ Time Frame: Baseline and weeks 96 to 104 ], Percentage of Hb Values Within 10.0-12.0 g/dL in Weeks 28-36 Without Use of Rescue Therapy [ Time Frame: Baseline and weeks 28 to 36 ], Percentage of Hb Values Within 10.0-12.0 g/dL in Weeks 44-52 Without Use of Rescue Therapy [ Time Frame: Baseline and weeks 44 to 52 ], Percentage of Hb Values Within 10.0-12.0 g/dL in Weeks 96-104 Without Use of Rescue Therapy [ Time Frame: Baseline and weeks 96 to 104 ], Time to First Hospitalization [ Time Frame: Baseline to week 104 ], Number of Days of Hospitalization Per Patient Exposure Year (PEY) [ Time Frame: Baseline to week 104 ], Time to First Use of Rescue Therapy (Composite of RBC, Transfusions, ESA Use, and IV Iron) in the First 24 Weeks of Treatment [ Time Frame: Baseline to week 24 ], Time to First Use of RBC Transfusions [ Time Frame: Baseline to week 104 ], Mean Monthly Number of RBC Packs [ Time Frame: Baseline to week 104 ], Mean Monthly Volume of Blood Transfused [ Time Frame: Baseline to week 104 ], Time to First Use of ESA Rescue Therapy [ Time Frame: Baseline to week 104 ], Time to First Use of IV Iron [ Time Frame: Baseline to week 104 ], Change From BL to Each Post-Dosing Visit in Total Cholesterol [ Time Frame: Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 68, 84, 104 ], Change From BL to Each Post-Dosing Visit in Low Density Lipoprotein (LDL)/High-Density Lipoprotein (HDL) Ratio [ Time Frame: Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 68, 84, 104 ], Change From BL to Each Post-Dosing Visit in Non-HDL Cholesterol [ Time Frame: Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 68, 84, 104 ], Change From BL to Each Post-Dosing Visit in Apolipoproteins A1 (ApoA1) [ Time Frame: Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 68, 84, 104 ], Change From BL to Each Post-Dosing Visit in Apolipoproteins B (ApoB) [ Time Frame: Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 68, 84, 104 ], Change From BL to Each Post-Dosing Visit in Ratio ApoB/ApoA1 [ Time Frame: Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 68, 84, 104 ], Percentage of Participants With Mean LDL Cholesterol <100 mg/dL Calculated Over Weeks 12 to 28 [ Time Frame: Weeks 12 to 28 ], Percentage of Participants Who Have Achieved Antihypertensive Treatment Goal in CKD Participants Over Weeks 12-28 [ Time Frame: Weeks 12 to 28 ], Change From BL to the Average Value of Weeks 12-28 in Quality of Life (QoL) SF-36 Physical Component Score (PCS) [ Time Frame: Baseline and weeks 12 to 28 ], Change From BL to the Average Value of Weeks 12-28 in Anemia Subscale (Ans) of Functional Assessment of Cancer Therapy (FACT-An) Score [ Time Frame: Baseline and weeks 12 to 28 ], Change From BL to the Average Value of Weeks 12-28 in Total FACT-An Score [ Time Frame: Baseline and weeks 12 to 28 ], Change From BL to the Average Value of Weeks 12-28 in the Euroqol Questionnaire - 5 Dimensions 5 Levels (EQ-5D 5L) Visual Analogue Scale (VAS) Score [ Time Frame: Baseline and weeks 12 to 28 ], Change From BL to the Average Value of Weeks 12-28 in Overall Work Impairment Due to Anaemic Symptoms [ Time Frame: Baseline and weeks 12 to 28 ], Percentage of Participants in Each Category in Patients' Global Impression of Change (PGIC) [ Time Frame: Week 12 to 28 ], Change From BL to Each Study Visit in Serum Hepcidin [ Time Frame: Baseline and weeks 4,12,20,36,52,104 ], Change From BL to Each Study Visit in Serum Ferritin [ Time Frame: Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104 ], Change From BL to Each Study Visit in Serum Transferrin Saturation (TSAT) [ Time Frame: Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104 ], Change From BL to Each Study Visit in Serum HbA1c Level [ Time Frame: Baseline and weeks 12, 28, 36, 44, 60, 84, 104 ], Change From BL to Each Study Visit in Fasting Blood Glucose [ Time Frame: Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104 ], Change From BL to Each Study Visit in Albumin/Creatinine Ratio in Urine [ Time Frame: Baseline and weeks 12, 24, 36, 52, 64, 76, 88, 104 ], Change From BL to Each Study Visit in Serum Creatinine (Cr) Ratio [ Time Frame: Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104 ], Time to Doubling of Serum Creatinine or Chronic Dialysis or Renal Transplant Compared to Baseline [ Time Frame: Baseline and year 0.5, year 1, year 1.5 and year 2 ], Time to CKD Progression (Composite of Doubling Serum Creatinine, Chronic Dialysis or Renal Transplant, and Death) [ Time Frame: Baseline and year 0.5, year 1, year 1.5 and year 2 ], Time to at Least 40% Decrease in eGFR From Baseline, Chronic Dialysis or Renal Transplant [ Time Frame: Baseline and year 0.5, year 1, year 1.5 and year 2 ]. All trials on the list are supported by NCI.. NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Listing a study does not mean it has been evaluated by the U.S. Federal Government. The Hb values from visit windows at weeks 28, 32 and 36 were used for the calculation of the average of weeks 28 to 36. 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. Participant has a history of alcohol or drug abuse within 2 years prior to randomization. Data analysis was completed using Kaplan-Meier estimate for cumulative proportion. The ALPS study is the first of three Astellas Phase 3 studies conducted mainly in EMEA to report. The Euroqol Questionnaire - 5 Dimensions 5 Levels (EQ-5D 5L) is a self-reported questionnaire. Participants received matching placebo for at least 52 weeks up to a maximum of 104 weeks. It provides an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures. The First event date was defined as Date of first dose of rescue medication during the efficacy emergent period and Analysis date of first dose intake was defined as date of first study drug dose intake collected on day 1. To compute the geometric mean of serum Cr (ratio) and associated 95% CI, the mean of log-transformed serum Cr (ratio) values and associated 95% CI are back-transformed to the raw scale. However, these drugs are linked with thromboses and cardiovascular events. Participant has a known untreated proliferative diabetic retinopathy, diabetic macular edema, macular degeneration and retinal vein occlusion. Data analysis was completed using Kaplan-Meier estimate for cumulative proportion. Data analysis was completed using Kaplan-Meier estimate for cumulative proportion. Dose-titration based upon regular measurement of Hb levels was performed until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. The study forms part of a wider large-scale global Phase 3 development program for roxadustat conducted in collaboration with its partner FibroGen, Inc. (NASDAQ: FGEN), and will ultimately support filing and reimbursement in Europe. Change from baseline to each planned assessment for non-HDL is reported. The study consisted of three study periods as follows: Choosing to participate in a study is an important personal decision. ROCKIES, SIERRAS and HIMALAYAS, evaluated roxadustat compared to epoetin alfa in DD patients. Fibrogen has a lot riding on pivotal data for roxadustat, its project for anaemia in chronic kidney disease. FG-4592 is a new-generation hypoxia-inducible factor prolyl hydroxylase inhibitor in early clinical trials at FibroGen for the oral treatment of iron deficiency anemia and renal failure anemia. The mean of the Participant's three most recent Hb values during the Screening period, obtained at least 4 days apart, must be less than or equal to 10.0 g/dL, with a difference of less than or equal to 1.0 g/dL between the highest and the lowest values. Study record managers: refer to the Data Element Definitions if submitting registration or results information. The Efficacy Emergent Period was defined as the evaluation period from the analysis date of first dose intake up to 7 days after the analysis date of last dose or EOT visit, whichever occured first. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com. Medication onset date was the date of the first use of rescue medication. Controlled Study (ALPS) ... LAPIS Phase 3 clinical trial … Participants received roxadustat according to the tiered weight-based approach, with starting doses of 70 mg given thrice weekly (TIW) to participants weighing up to 70 kg and 100 mg given TIW to participants weighing more than 70 kg. HIMALAYAS evaluated roxadustat compared to epoetin alfa in incident dialysis (ID) patients; there were ID patients in ROCKIES and SIERRAS. Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ): Anemia in Chronic Kidney Disease in Non-dialysis Patients. Participant has active or chronic gastrointestinal bleeding. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Scores were calculated with the formula to derive the overall work impairment on each timepoints in percentage, and then changes of the percentage from baseline are reported. Participants without RBC transfusion were included with a value of zero. Roxadustat was administered initially according to the tiered weight-based dosing, where participants with weight from ≥ 45 to ≤ 70 kg received 70 mg and participants with > 70 to ≤ 160 kg received 100 mg of roxadustat. Baseline assessment was the assessment on day 1 (average of the three readings). All assessments collected after initiation of chronic dialysis (acute or chronic) are excluded from the analysis. Roxadustat is under regulatory review for the treatment of anemia of chronic Analysis date of first dose intake was defined as the date of first study drug intake collected on day 1 visit. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887600. AstraZeneca in CVRM Roxadustat was dosed TIW throughout the Treatment Period, except if a subject required <20 mg TIW (i.e., <60 mg per week) to maintain Hb levels in the Maintenance Phase, then the dosing frequency could have been reduced in a step-wise fashion (e.g., TIW to BIW, BIW to QW, QW to Q-2 Week [every 2 weeks]). It is thought that, compared with ESAs, they could lead to lower but more consistent blood erythropoietin levels, thus having better cardiovascular safety. Data was analysed using Kaplan-Meier estimate for cumulative proportion. • Strong Fourth Quarter China Roxadustat Net Sales of $29.2 Million and 2020 full-year Net Sales of $72.5 Million • FDA to hold Advisory Committee Meeting on Roxadustat New Drug Application SAN FRANCISCO, March 01, 2021 (GLOBE NEWSWIRE) -- … Leerink analysts noted that roxadustat’s efficacy now looked “more or less certain”. Time to First Use of ESA Rescue Therapy during efficacy emergent period. Time to first hospitalization was defined in years as the First event date during the Efficacy Emergent Period - (Analysis date of first dose intake +1)/365.25. Hb response was measured as Yes or No; Yes was defined as Hb ≥11.0 g/dL and Hb increase from baseline by ≥ 1.0 g/dL, for participants with baseline Hb > 8.0 g/dL; or Hb increase from baseline by ≥ 2.0 g/dL, for participants with baseline Hb ≤ 8.0 g/dL. Topline results were announced demonstrating superiority in efficacy vs. placebo in both Hb response rate in the 1st 24 weeks and Hb change from baseline at Weeks 28 to 52. The Hb values from visit windows from weeks 28 to 36 were used for the calculation of the average regardless of rescue therapy. The nondialysis CKD trials – OLYMPUS, ANDES, and ALPS – involved 2391 roxadustat-treated patients with nondialysis-dependent CKD who had baseline Hb of 10 g/dL or less. Realistically, roxadustat needs to show a better safety profile to have a chance of meeting the high expectations set by the sellside. Talk with your doctor and family members or friends about deciding to join a study. The safety emergent period was defined as the evaluation period from the analysis date of first drug intake up to 28 days after the analysis date of last dose or end of study (EOS), whichever occurred first. By using this site, you agree that we may store and access cookies on your device. The percentage of Hb values measured during weeks 28-36 within 10.0 -12.0 g/dL, without having received rescue therapy within 6 weeks prior to and during the 8-week evaluation period is reported. Participant has been treated with iron-chelating agents within 4 weeks prior to randomization. The efficacy emergent period was defined as the evaluation period from the analysis date of first dose intake up to 7 days after the analysis date of last dose or EOT visit, whichever occurred first. The data evaluated until the safety emergent period, which was defined as the evaluation period from analysis date of first drug intake up to 28 days after the analysis last dose, and results were presented for every 6 months up to 2 years. The Hb values from visit windows from weeks 96 to 104 were used for the calculation of the average regardless of rescue therapy. Time to first occurrence of hypertension was defined as first date where SBP criterion or DBP criterion is met, whichever occurred first.
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