This trial (FGCL-4592-806) was a randomized, open-label, active-controlled, phase 3 trial evaluating the efficacy and safety of roxadustat ⦠This prevents HIF breakdown and promotes HIF activity. In exceptional cases, when patient participation in a clinical trial is not possible, and there are no other therapies available to treat the patientâs disease or condition, the patientâs physician may request access to one of our investigational drugs on humanitarian grounds. Roxadustat is in Phase 3 clinical development in the U.S. and Europe and in Phase 2/3 development in China for anemia associated with myelodysplastic syndromes (MDS), and in a Phase 2 U.S. trial for treatment of chemotherapy-induced anemia. The Institute for Clinical and Economic Review is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. Talk to your doctor for help in deciding if one is right for you. Roxadustat is progressing through a global Phase 3 clinical development program for the treatment of anemia in chronic kidney disease, is in Phase 3 development in the U.S. and Phase 2/3 development in China for treatment of anemia associated with myelodysplastic syndromes (MDS), and in a Phase 2 U.S. trial for treatment of chemotherapy-induced anemia (CIA). Roxadustat is approved in China, Japan (under the name Evrenzo), and Chile for the treatment of anemia in CKD in NDD and DD adult patients. Roxadustat Significantly Increased Hemoglobin Levels for Chronic Kidney Disease Patients ⦠Location: 2 locations, Complementary & Alternative Medicine (CAM), Coping with Your Feelings During Advanced Cancer, Late Effects of Childhood Cancer Treatment, Frederick National Laboratory for Cancer Research, Milestones in Cancer Research and Discovery, Tech Transfer & Small Business Partnerships, Step 1: Application Development & Submission, How to Work With Your Health Insurance Plan, Questions to Ask about Treatment Clinical Trials, Drugs Approved for Different Types of Cancer, Drugs Approved for Conditions Related to Cancer, Efficacy and Safety of FG-4592 for Treatment of Anemia in Patients With Lower Risk MDS With Low Red Blood Cell Transfusion Burden, Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia, U.S. Department of Health and Human Services. Our most advanced product candidate, roxadustat, is currently approved in both China and Japan for the treatment of anemia in CKD patients on dialysis and patients not on dialysis. This randomized, double-blind, placebo-controlled, Phase 3 study evaluated the efficacy and safety of roxadustat in patients with NDD-CKD and CKD-related anemia (ClinicalTrials.gov number, NCT01750190) (Figure 1). No serious drug-related adverse events had occurred in clinical trials to date. Full title of the trial. Before a new treatment can be made widely available, it must go through rigorous testing involving extensive preclinical and clinical studies. Clinical Trial Results: A Phase 1 Crossover Study to Assess the Relative Bioavailability of Roxadustat Following a Single Dose of Pediatric Azo Dye-free Tablet and Pediatric Azo Dye-free Mini-tablet (Solid and Suspension) Compared to a Single Dose of Azo Dye-containing Tablet in Healthy Adult Subjects Roxadustat also advanced into Phase I clinical trials in that same year. Clinical trials are research studies that involve people. These requests are sometimes referred to as âexpanded accessâ or âcompassionate useâ, though other terms may be used for the same request. In clinical trials ⦠Roxadustat Trials. In the OLYMPUS trial, roxadustat demonstrated a statistically significant improvement in Hb levels from baseline, with a mean increase of 1.75g/dL averaged over weeks 28 to 52, compared to 0.40g/dL with placebo, the primary efficacy endpoint. Should you locate a clinical study with a participating site that you are interested in, you or your physician may contact that site directly to request more information about enrollment. HIMALAYAS is a 1,043-patient global Phase 3 randomized, open-label, active-controlled trial to assess the efficacy and safety of roxadustat compared to epoetin alfa, an ⦠In addition, ... FG-4592-082 (Roxadustat) Clinical Trial Open to Recruitment. Upon administration, roxadustat binds to and inhibits HIF-PHI, an enzyme responsible for the degradation of transcription factors in the HIF family under normal oxygen conditions. 409 Illinois Street, San Francisco, CA 94158. A Phase 3 Randomized Double-Blind Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients with Lower Risk Myelodysplastic Syndrome (MDS) with Low Red Blood Cell (RBC) Transfusion Burden (LTB) A.3.1. The trial design shows vadadustat in contrast to its competitor, AstraZeneca / FibroGenâs roxadustat, which has established noninferior efficacy and safety in comparison to a placebo in nondialysis-dependent (NDD) CKD patients, as per recent data presented at the American Society of Nephrology (ASN) conference. SAN FRANCISCO, June 08, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) announced data from three roxadustat clinical trials, including the Phase 3 DOLOMITES study evaluating roxadustat for treatment of anemia in non-dialysis-dependent CKD patients compared to darbepoetin alfa, and ophthalmology findings from a Japan Phase 3 study evaluating roxadustat compared to darbepoetin ⦠Roxadustat is an orally bioavailable, hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), with potential anti-anemic activity. A.3. Thus, the structural features of roxadustat might affect thyroid hormone dynamics. Clinical trials have shown that roxadustat corrected anemia by stimulating the expression of endogenous erythropoietin, which promoted erythropoiesisb and was then non-inferior and superior to placebo and epoetin. AstraZeneca will present pooled efficacy and cardiovascular safety analyses from the Phase III clinical program of roxadustat for the treatment of ane. Two phase 3 clinical trials have verified the efficacy and safety of roxadustate as therapy for anemia in ⦠Roxadustat in Patients Not Receiving Dialysis This phase 3, randomized trial in China compared the efficacy and safety of roxadustat, an oral ⦠A Study to Assess the Relative Bioavailability of Roxadustat Following a Single Dose of Pediatric Azo Dye-free Tablet Formulation and Pediatric Azo Dye-free Mini-tablet Formulation Compared to a Single Dose of Azo Dye-containing Tablet Formulation in Healthy Adult Subjects However, if a particular clinical trial drug is considered an option by the haematologist, it is sometimes possible to obtain the drug outside the trial, on the basis of compassionate use. All trials on the list are supported by NCI. The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anemia in patients with Lower Risk Myelodysplastic Syndrome and Low Red Blood Cell Transfusion Burden. The clinical trials on this list are studying Roxadustat. For our policy on expanded access or for more information, please contact us here. In Japan, three types of HIF-PH inhibitors (daprodustat, roxadustat and vadadustat) are widely used, but hypothyroidism has been confirmed as an adverse event in clinical trials only in roxadustat. Clinical trials look at new ways to prevent, detect, or treat disease. Home » FG-4592-082 (Roxadustat) Clinical Trial Open to Recruitment. Patients who participate in clinical trials may gain access to investigational treatments before they are widely available, and play an important role in helping researchers and clinicians answer key questions about potential new products. Clinical Experience with Roxadustat, a HIF-PHI, in the Treatment of CKD-Associated Anemia Anatole Besarab MD Executive Director Clinical Research FibroGen, Inc., San Francisco CA, USA In 2007, Phase II clinical trials of FG-2216 for the treatment of renal anemia in Japan were terminated because a patient died from fulminant hepatitis; Phase II clinical trials of roxadustat ⦠Pamrevlumab is being evaluated in Phase 3 clinical studies for the treatment idiopathic pulmonary fibrosis, pancreatic cancer, and in Phase 2 for the treatment of Duchenne muscular dystrophy (DMD) and COVID-19. These studies are carefully conducted within guidelines set by the U.S. Food and Drug Administration (FDA) and corresponding regulatory authorities outside the U.S. The purpose of clinical trials is to evaluate the safety and effectiveness of promising new therapeutics. NCIâs basic information about clinical trials explains the types and phases of trials and how they are carried out. At FibroGen, we are dedicated to advancing first-in-class medicines that have the potential to provide new and effective treatment options to the patients who need them. Clinical trials are research studies that involve people. This review will summarize recent findings of roxadustat ⦠Research FOR Patients-For an informed and empowered opinion-All the trials listed in our site have been properly vetted for ⦠Please review the information found on this website as well as at clinicaltrials.gov. All trials on the list are supported by NCI.. NCIâs basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical Trials Nct Page A Study to Assess the Relative Bioavailability of Roxadustat Following a Single Dose of Pediatric Azo Dye-free Tablet Formulation and Pediatric Azo Dye-free Mini-tablet Formulation Compared to a Single Dose of Azo Dye ⦠AstraZeneca today announced that the Phase III OLYMPUS and ROCKIES trials for roxadustat each met their primary efficacy endpoints for the treatment of patients with anaemia in chronic kidney disease (CKD) that are either non-dialysis-dependent or dialysis-dependent, respectively. Roxadustat is also in clinical development for anemia associated with MDS and for chemotherapy-induced anemia. Roxadustat Clinical Trials, 43 Results, Page 1. We believe that participating in our clinical trials is the best way for patients to access our investigational medicines prior to regulatory approval. Roxadustat is an orally hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to promote erythropoiesis on patients with chronic kidney disease. Trial Design and Oversight. Roxadustat Trials Roxadustat is progressing through a global Phase 3 clinical development program for the treatment of anemia in chronic kidney disease, is in Phase 3 development in the U.S. and Phase 2/3 development in China for treatment of anemia associated with myelodysplastic syndromes (MDS), and in a Phase 2 U.S. trial for treatment of chemotherapy-induced anemia (CIA). FG-4592-082 (Roxadustat) Clinical Trial Open to Recruitment 16 Sep. 2019. Location: 6 locations, The purpose of this study is to find out if roxadustat (also known as FG-4592) is safe and effective for the treatment of anemia in people receiving chemotherapy treatment for cancer. The clinical trials on this list are studying Roxadustat. There are currently more than 15 phase 3 clinical trials worldwide assessing the efficacy and safety of roxadustat in CKD patients with anemia. Clinical trials look at new ways to prevent, detect, or treat disease. Roxadustat also improved Hb levels from baseline in a subgroup of patients with elevated high-sensitivity C-reactive protein (hsCRP) levels of greater ⦠The NDA for roxadustat is based on positive results from a global Phase 3 program encompassing more than 8,000 patients. Roxadustat is in global Phase 3 clinical development in the U.S. and Europe and in Phase 2/3 development in China for anemia associated with myelodysplastic syndromes (MDS), and in a Phase ⦠You may want to think about taking part in a clinical trial. Roxadustat, the first small-molecule HIF-PHD inhibitor, has completed the phase 3 trials. About Anemia of CKD AstraZenecaâs investigational anaemia treatment, roxadustat, has proved successful in two Phase III trials that evaluated the efficacy and safety of the drug. Roxadustat, an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, is the first HIF-PH inhibitor accepted by the FDA for review for the treatment of anemia of CKD. The study was conducted at 163 sites in the United States, South America, Australia, New Zealand, and Asia.