alps clinical trial roxadustat

Two more European trials are set to report, while five trials are ongoing in the US, where the project is partnered with Astrazeneca. Change from baseline to each planned assessment for total cholesterol is reported. Participant has a ferritin level greater than or equal to 30 ng/mL (greater than or equal to 67.4 pmol/L) at screening. Fibrogen has a lot riding on pivotal data for roxadustat, its project for anaemia in chronic kidney disease. 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. Two phase 3 European studies enrolled non–dialysis-dependent (NDD; ALPS) and dialysis-dependent (DD; PYRENEES) patients with CKD anemia. Trials in China and Japan have already read out positively, and an approval decision in China is expected by the end of the year. 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. Participants without ESA rescue were censored at the end of treatment. If this value was missing, the latest value prior to first study drug administration was used. 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. Mean LDL cholesterol <100 mg/dL over weeks 12 to 28 was defined as a binary variable (Yes/No), where Yes was defined as mean LDL cholesterol <100 mg/dL over weeks 12 to 28. Baseline was defined as the value on day 1. 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. Placebo 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. Roxadustat is currently approved in China for the treatment of patients with anaemia in DD CKD. 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). Work productivity and activity impairment: anemic symptoms (WPAI:ANS) questionnaire version 2 was used to measure work and activity impairment during the last seven days due to anemia. Participant has had more than one dose of IV iron within 12 weeks prior to randomization. For the last 2 questions, they were scored from 0-10 with 0 identifying no effect on work and 10 completely prevented from working. Oncology decisions ahead for the FDA, More patience needed for novel anaemia class’s biggest test. 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 the end of treatment (EOT) visit, whichever occurred first. 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. AstraZeneca in CVRM Participant has received a RBC transfusion within 8 weeks prior to randomization. Update on US regulatory review of roxadustat in anaemia of chronic kidney disease fre, dec 18, 2020 23:05 CET. The Hb values from visit windows from weeks 28 to 36 were used for the calculation of the average regardless of rescue therapy. 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. 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. Roxadustat inhibits hypoxia inducible factor (HIF) prolyl hydroxylase activity. A higher score indicates better QoL. For participants who experienced more than one hospitalization, only their first event following study treatment was used. If baseline value was missing, the value from screening visit was used. Participant has a serum folate level greater than or equal to lower limit of normal at screening. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Change from baseline to each planned assessment for apolipoproteins A1 is reported. 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. The EQ-5D 5L is used as a measure of respondents' Health Related Quality of Life (HRQoL). During efficacy emergent period, the mean monthly number of RBC packs was calculated as the sum of 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. ROCKIES, SIERRAS and HIMALAYAS evaluated roxadustat compared to epoetin alfa in DD and incident dialysis (ID) patients. 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. 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. Data analysis was completed using Kaplan-Meier estimate for cumulative proportion. 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. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887600. The OLYMPUS, ALPS and ANDES trials evaluated roxadustat compared to placebo in NDD patients. Realistically, roxadustat needs to show a better safety profile to have a chance of meeting the high expectations set by the sellside. Read our, ClinicalTrials.gov Identifier: NCT01887600, Interventional Together with the Functional Assessment of Cancer Therapy - General (FACT-G), the Anemia Subscale (AnS) is referred to as the FACT-An Total. The overall safety profile was consistent with results seen in previous roxadustat trials; pooled safety findings were reported in a late breaker abstract at the meeting. Baseline assessment was the assessment from day 1 visit. This was the primary efficacy endpoint for EU (EMA). Analysis was completed on all values collected on day 1 and weeks 12, 20 and 28. 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. All scheduled and unscheduled hemoglobin values from weeks 44 to 52 were taken into account for calculating the average values. 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. 2012-005180-27: Trial protocol. The 36-Item short-form health survey (SF-36) is a multi-purpose survey with 36 questions. 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. ROCKIES, SIERRAS and HIMALAYAS, evaluated roxadustat compared to epoetin alfa in DD patients. The percentage of Hb values measured during weeks 44-52 with values 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. 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 endpoint was defined as time to doubling serum creatinine or chronic dialysis or renal transplant what ever came first. The Hb values from visit windows from weeks 96 to 104 were used for the calculation of the average regardless of rescue therapy. 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.Data analysis was completed using Kaplan-Meier estimate for cumulative proportion. HIMALAYAS evaluated roxadustat compared to epoetin alfa in incident dialysis (ID) patients; there were ID patients in ROCKIES and SIERRAS. HIMALAYAS evaluated roxadustat compared to epoetin alfa in incident dialysis (ID) patients; there were ID patients in ROCKIES and SIERRAS. They put peak roxadustat revenues at $5.8-8.1bn, depending on the drug’s performance on MACE. Roxadustat is not the only HIF-PH inhibitor in town. 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. Participant is anticipated to have elective surgery that is expected to lead to significant blood loss or anticipated elective coronary revascularization. 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. Medication onset date was the date of the first use of rescue medication. Participant has a known history of myelodysplastic syndrome or multiple myeloma. Baseline assessment was the assessment from day 1 visit. Participant's alanine aminotransferase (ALT), aspartate aminotransferase (AST) levels are less than or equal to 3 x upper limit of normal (ULN), and total bilirubin (TBL) is less than or equal to 1.5 x ULN. First event date was defined as date of dialysis or date of 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. Baseline was assessed on Day 1 visit. Link to results on Astellas Clinical Study Results website, U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. In September 2018, Astellas announced high-level results from the Phase III ALPS trial. Baseline was defined as the value on day 1. This suggests that roxadustat provides adistinct pharmacological and clinical profile that may provide a saferand more convenient treatment of CKD anemia. Data analysis was completed using Kaplan-Meier estimate for cumulative proportion. Participants received roxadustat for at least 52 weeks up to a maximum of 104 weeks. 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. 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. Information provided by (Responsible Party): Astellas Pharma Inc ( Astellas Pharma Europe B.V. ). 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. By Mark Terry . Roxadustat is an oral HIF-PHI in late-stage development for treatment of CKD anemia. Participant has a diagnosis of chronic kidney disease, with Kidney Disease Outcomes Quality Initiative (KDOQI) Stage 3, 4 or 5, not receiving dialysis; with an Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73 m^2 estimated using the abbreviated 4-variable Modification of Diet in Renal Disease (MDRD) equation. ROCKIES, SIERRAS and HIMALAYAS, evaluated roxadustat compared to epoetin alfa in DD patients. All assessments collected after initiation of chronic dialysis (acute or chronic) are excluded from the analysis. Roxadustat passes Alps test but has bigger mountains to climb, Akebia plays spot the difference with investors, Pivotal data on Akebia's anaemia project please, but safety concerns linger, ASN 2019 preview – fears grow that roxadustat could come up short, Akebia gets high with second Japanese partner, 2020 wins top of the froths for biotech stocks, Go or no go? 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]. 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. Participant has a history of alcohol or drug abuse within 2 years prior to randomization. Controlled Study (ALPS) ... LAPIS Phase 3 clinical trial … 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. Data analysis was completed using Kaplan-Meier estimate for cumulative proportion. 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. Roxadustat is under regulatory review for the treatment of anemia of chronic  (Clinical Trial), Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor), A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis, 18 Years and older   (Adult, Older Adult), La Fe Santo Domingo, Dominican Republic, 5072, Santiago de los Caballeros, Dominican Republic, 51000, Santo Domingo, Dominican Republic, 103201, Nizhny Novgorod, Russian Federation, 603032, Rostov-on-don, Russian Federation, 344029, Saint Petersburg, Russian Federation, 192242, Saint Petersburg, Russian Federation, 196247, Saint Petersburg, Russian Federation, 197089, Saint-Petersburg, Russian Federation, 194354, Observatory, Cape Town, South Africa, 7925, Bloemfontein, Free State, South Africa, 9324, Durban, Kwa Zulu Natal, South Africa, 4001, Welwyn Garden City, United Kingdom, AL7 4HQ, Westcliff-on-Sea, United Kingdom, SS0 0RY. Data analysis was completed using Kaplan-Meier estimate for cumulative proportion. 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 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. Participant has had any prior organ transplant (that has not been explanted) or a scheduled organ transplantation. This study was conducted to treat anemia in patients with chronic kidney disease. 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. The time to CKD progression was calculated (in years) as (First event date - Analysis date of first dose intake + 1) / 365.25. 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. 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. Baseline assessment was the assessment on day 1 (average of the three readings). Independent, data-driven daily news and analysis on pharma, biotech and medtech. The OLYMPUS, ALPS and ANDES trials evaluated roxadustat compared to placebo in NDD patients. Talk with your doctor and family members or friends about deciding to join a study. Overall work impairment due to ANS was calculated as 100 x Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]. If the baseline assessment was missing, then the latest available value prior to first drug administration was used. Participants without any blood pressure measurement were excluded. Analysis date of first dose intake was defined as date of first study drug dose intake collected on day 1 visit. Data analysis was completed using Kaplan-Meier estimate for cumulative proportion. Fibrogen’s roxadustat has its first European win from the Alps trial, but the most important event is still to come. Changes from baseline to each timepoint were reported in unit 'fraction of 1'. The clinical trials on this list are studying Roxadustat. Questions include asking if participant is working, how many hours the person missed work due to anemic symptoms, how many hours the person missed work due to other reasons, how many hours participant actually worked and how the anemic symptoms impacted their productivity and ability to do daily activities. Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ): Anemia in Chronic Kidney Disease in Non-dialysis Patients. 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. Baseline was defined as the value on day 1. The physical component score was calculated based on the results of the SF-36 scores. 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. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Baseline was defined as the value on day 1. Enrollment was completed in the WHITNEY US Phase 2 roxadustat clinical trial in chemotherapy-induced anemia (CIA) in 4Q 2020. Participant has been treated with iron-chelating agents within 4 weeks prior to randomization. The focus of the drug is on anemia. Individually, all six Phase 3 trials included in these pooled analyses (OLYMPUS, ANDES, ALPS, HIMALAYAS, SIERRAS, and ROCKIES) achieved the … Time to first use of rescue therapy in years. The SF-36 scores ranged from 0-100 with higher scores indicating better health status. Change from baseline to each planned assessment for ratio of ApoB/ApoA1 is reported. 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). Participant has received any ESA treatment within 12 weeks prior to randomization. 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. 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. 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. 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. In case of missing data, no imputation rules were applied. In case of missing data, no imputation rules were applied. Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis (ALPS) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. 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) -- … In case of missing data, no imputation rules were applied. 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. Clinical trials are research studies that involve people. The EQ-5D 5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (VAS). 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.

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