To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please remove one or more studies before adding more. Participant has participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives or limit set by national law, whichever is longer, prior to the initiation of Screening. Total Fact-An score is composed of FACT-G and Ans scales. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Patients in the roxadustat arm had a hemoglobin response rate of 88.2% compared with 84.4% in the epoetin alfa arm, meeting EU’s primary end point noninferiority criterion. 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. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887600. Participants can have more than one hospitalization. Change from baseline to each planned assessment for LDL/HDL ratio is reported. ROCKIES, SIERRAS and HIMALAYAS evaluated roxadustat vs. epoetin alfa in DD patients. 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. 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. 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). Data analysis was completed using Kaplan-Meier estimate for cumulative proportion. Derived only for participants with at least one hospitalization. But the main questions over the asset now involve its side-effect profile. Baseline was defined as the value on day 1. The time to first use of rescue therapy was calculated (in years) as: (First event date - Analysis date of first dose intake + 1) / 365.25. Participant has been treated with iron-chelating agents within 4 weeks prior to randomization. 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. Participant is positive for any of the following: Human Immunodeficiency Virus (HIV); hepatitis B surface antigen (HBsAg); or anti-hepatitis C virus antibody (anti-HCV Ab). Time to event was defined as (First event date - Analysis date of first dose intake + 1) / 365.25. HIMALAYAS evaluated roxadustat compared to epoetin alfa in incident dialysis (ID) patients; there were ID patients in ROCKIES and SIERRAS. The Hb values from visit windows from weeks 44 to 52 were used for the calculation of the average regardless of rescue therapy. EudraCT number. Data analysis was completed using Kaplan-Meier estimate for cumulative proportion. A higher score indicates better QoL. Annualized eGFR slope over time was estimated by a random slopes and intercepts model using all available eGFR values (one baseline and all post-treatment values up to EOT period or start of dialysis adjusted on baseline Hb, region, CV history at baseline and the interaction terms (baseline eGFR by timepoint and baseline Hb by timepoint). 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). Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ): Anemia in Chronic Kidney Disease in Non-dialysis Patients. The nondialysis CKD trials – OLYMPUS, ANDES, and ALPS – involved 2368 roxadustat and 1865 placebo recipients, both with mean baseline hemoglobin (Hb) values of 9.10 g/dL. Medication onset date was the date of the first use of rescue medication. Participant has a transferrin saturation (TSAT) level greater than or equal to 5% at screening. The survey measures eight dimensions or scales: (1) physical functioning (PF) (10 items); (2) role limitations due to physical health problems (RP) (3 items); (3) bodily pain (BP) (2 items); (4) social functioning (SF) (2 items); (5) general health perceptions (GH) (5 items); (6) role limitations due to emotional problems (RE) (3 items); (7) vitality, energy or fatigue (VT) (4 items); and (8) mental health (MH) (5 items). The global Phase III programme consists of more than 9,000 patients in trials conducted by AstraZeneca, FibroGen and Astellas. Hemoglobin is important for the transport of oxygen in your blood. 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. Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor that increases endogenous erythropoietin and enhances iron utilization. HIF causes the physiological response to low oxygen conditions. Still, the emergence of biosimilar ESAs would make this tough. Baseline assessment was the assessment from day 1 visit. Readout was delayed earlier this year (More patience needed for novel anaemia class’s biggest test, February 28, 2018). HIMALAYAS evaluated roxadustat compared to epoetin alfa in ID patients; ROCKIES and SIERRAS included ID patients. If roxadustat ends up with a similar label to the ESAs, the former's greater convenience as an oral drug could help it gain market share in the non-dialysis population, Bernstein analysts believe. Baseline was defined as the value on day 1. Positive top-line data from the ALPS study confirms the efficacy and safety of roxadustat, a Phase III-stage product which could be the first a new class of orally active agents with potential in the treatment of anemia associated with chronic kidney disease. The Euroqol Questionnaire - 5 Dimensions 5 Levels (EQ-5D 5L) is a self-reported questionnaire. 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. It is thought that, compared with ESAs, they could lead to lower but more consistent blood erythropoietin levels, thus having better cardiovascular safety. 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 on day 1 (average of the three readings). Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participant has a diagnosis or suspicion (e.g., complex kidney cyst of Bosniak Category 2F or higher) of renal cell carcinoma on renal ultrasound within 12 weeks prior to randomization. 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. Today's win in the European Alps trial will help its cause – but a safety analysis of the global pivotal programme, due in early 2019, is what investors are really waiting for. Change from BL in SF-36 VT sub-score to the average value in weeks 12-28 was calculated using the physical component scores (PCS) of SF-36. By using this site, you agree that we may store and access cookies on your device. 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. Fibrogen has a lot riding on pivotal data for roxadustat, its project for anaemia in chronic kidney disease. [18,19] The Hb values from visit windows at weeks 28, 32, 36, 40, 44, 48 and 52 were used for the calculation of the average of weeks 28 to 52. Leerink analysts noted that roxadustat’s efficacy now looked “more or less certain”. Change from baseline in SF-36 PF normalized sub-score compared to the average PF sub-score of weeks 12 to 28. If the value was missing, the latest value prior to first study drug administration was used. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, extreme problems. The SF-36 scores ranged from 0-100 with higher scores indicating better health status. 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. Analysis was completed on all values collected on day 1 and weeks 12, 20 and 28. Participants without RBC transfusion were included with a value of zero. Participant has received any ESA treatment within 12 weeks prior to randomization. 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). 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. 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. 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. This was the primary efficacy endpoint for EU (EMA). Participant has a history of malignancy, except the following: cancers determined to be cured or in remission for greater than or equal to 5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps. The focus of the drug is on anemia. If baseline value was missing, the value from screening visit was used. Participants who discontinued or received rescue therapy prior to the first Hb response or before the second consecutive Hb value defined as a response were classified as non responders and were censored at week 24 or end of efficacy emergent period, whichever came first. ROCKIES, SIERRAS and HIMALAYAS, evaluated roxadustat compared to epoetin alfa in DD patients. Information provided by (Responsible Party): Astellas Pharma Inc ( Astellas Pharma Europe B.V. ). Two phase 3 European studies enrolled non–dialysis-dependent (NDD; ALPS) and dialysis-dependent (DD; PYRENEES) patients with CKD anemia. 1 March 2021 — AstraZeneca and FibroGen, Inc. (FibroGen) today announced that the US Food and Drug Administration (FDA) informed FibroGen that it will convene a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the new drug application for roxadustat. 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. 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. 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. 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. 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. Participant has had more than one dose of IV iron within 12 weeks prior to randomization. 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. First event date was defined as first occurrence of serum creatinine being doubled compared with baseline, first occurrence of chronic dialysis or renal transplant, occurrence of participants who died (whichever occurred first). 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. ROCKIES, SIERRAS and HIMALAYAS, evaluated roxadustat compared to epoetin alfa in DD patients. Change from baseline to each planned assessment for apolipoproteins B is reported. 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. Participant has had any prior organ transplant (that has not been explanted) or a scheduled organ transplantation. HIF causes the physiological response to low oxygen conditions. Roxadustat met its objectives in the PIII randomised, double-blind, placebo-controlled ALPS study (NCT01887600) in 597 CKD pts with Anemia not on Dialysis. 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. AstraZeneca in CVRM Participants without ESA rescue were censored at the end of treatment. 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. Talk with your doctor and family members or friends about deciding to join a study. Read our, ClinicalTrials.gov Identifier: NCT01887600, Interventional Fibrogen’s roxadustat has its first European win from the Alps trial, but the most important event is still to come. ROCKIES, SIERRAS and HIMALAYAS, evaluated roxadustat compared to epoetin alfa in DD patients. The last Hb value must be within 10 days prior to randomization. Crucially, there did not appear to be any safety signals. Oral iron was allowed in this study. If this value was missing, the latest value prior to first study drug administration was used. 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]). ROCKIES, SIERRAS and HIMALAYAS evaluated roxadustat compared to epoetin alfa in DD and incident dialysis (ID) patients. Participant has a serum vitamin B12 level greater than or equal to lower limit of normal at screening. 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 ]. Oncology decisions ahead for the FDA, More patience needed for novel anaemia class’s biggest test. Methods. Baseline was defined as the value on day 1. The EQ-5D 5L is used as a measure of respondents' Health Related Quality of Life (HRQoL). For each scale scores range from 0-100. Occurrence of achieved antihypertensive treatment goal was defined as the average SBP < 130 mmHg and the average DBP < 80 mmHg over the period of weeks 12-28. Baseline was assessed on Day 1 visit. The OLYMPUS, ALPS and ANDES trials evaluated roxadustat vs. placebo in NDD patients. A mean blood pressure reduction of 2.6 ± 9.6 mm Hg from baseline was observed in the phase 2b trial of 16 and 24 weeks of treatment with roxadustat. Participants received matching placebo 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. Getting a clean safety label will be particularly important if roxadustat is to be used in the less sick non-dialysis-dependent kidney disease population, which the Leerink analysts forecast will account for 45% of the drug’s sales. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Baseline assessment was the assessment from day 1 visit. 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 MAP was derived for each visit from the average systolic (SBP) and diastolic blood pressure (DBP) calculated for each visit using the three readings and the following equation: MAP = (2/3) * DBP + (1/3) * SBP. 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. Roxadustat is an oral HIF-PHI in late-stage development for treatment of CKD anemia. If this value was missing, the latest value prior to first study drug administration was used. For a participant without rescue therapy before Hb response (defined in 1 primary outcome), the time to achieve Hb response was calculated (in weeks) as: (First event date - Analysis date of first dose intake + 1) / 7 where First event date was defined as First date of both values that met the criteria for response. HIMALAYAS evaluated roxadustat compared to epoetin alfa in incident dialysis (ID) patients; there were ID patients in ROCKIES and SIERRAS.” The clinical trials on this list are studying Roxadustat. For participants who experienced more than one hospitalization, only their first event following study treatment was used. 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 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. 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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. Patients were given roxadustat twice weekly or TIW in doses ranging from 0.7 and 2.0 mg/kg. If baseline value was missing, value from screening visit was used. The Hb values from visit windows from weeks 96 to 104 were used for the calculation of the average regardless of rescue therapy. Participant has a known history of myelodysplastic syndrome or multiple myeloma. Participant has received a RBC transfusion within 8 weeks prior to randomization. Why Should I Register and Submit Results? AstraZeneca in CVRM Study record managers: refer to the Data Element Definitions if submitting registration or results information. It provides an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures. HIMALAYAS evaluated roxadustat compared to epoetin alfa in incident dialysis (ID) patients; there were ID patients in ROCKIES and SIERRAS. This theory will be put to the test when the full phase III programme for roxadustat reads out. The AnS scale contains 13 fatigue specific items (the Fatigue Score) plus 7 items related to anemia. Realistically, roxadustat needs to show a better safety profile to have a chance of meeting the high expectations set by the sellside. Hemoglobin (Hb) response was measured as Yes or No. The sum of the durations of all hospitalizations in days was adjusted for the duration of exposure. In case of missing data, no imputation rules were applied. 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. Update on US regulatory review of roxadustat in anaemia of chronic kidney disease fre, dec 18, 2020 23:05 CET. Participant has chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosus, rheumatoid arthritis, celiac disease) even if it is currently in remission. Clinical trials are research studies that involve people. 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. Baseline assessment was the assessment from day 1 visit. The SF-36 scores ranged from 0-100 with higher scores indicating better health status. The VAS records the respondent's self-rated health status on a graduated (0-100) scale, where the answers are labeled 'Best imaginable health state' and 'Worst imaginable health state' with higher scores for higher HRQoL.