These requests are sometimes referred to as âexpanded accessâ or âcompassionate useâ, though other terms may be used for the same request. A.3. 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. 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. 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. Roxadustat Significantly Increased Hemoglobin Levels for Chronic Kidney Disease Patients ⦠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. 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). This review will summarize recent findings of roxadustat ⦠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 ⦠Before a new treatment can be made widely available, it must go through rigorous testing involving extensive preclinical and clinical studies. 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. 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). This prevents HIF breakdown and promotes HIF activity. 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. Trial Design and Oversight. 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 ⦠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 No serious drug-related adverse events had occurred in clinical trials to date. NCIâs basic information about clinical trials explains the types and phases of trials and how they are carried out. 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. 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 ⦠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 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. 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). 409 Illinois Street, San Francisco, CA 94158. Roxadustat Trials. Roxadustat is an orally hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to promote erythropoiesis on patients with chronic kidney disease. The purpose of clinical trials is to evaluate the safety and effectiveness of promising new therapeutics. 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. 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. We believe that participating in our clinical trials is the best way for patients to access our investigational medicines prior to regulatory approval. For our policy on expanded access or for more information, please contact us here. Full title of the trial. Roxadustat in Patients Not Receiving Dialysis This phase 3, randomized trial in China compared the efficacy and safety of roxadustat, an oral ⦠About Anemia of CKD AstraZeneca will present pooled efficacy and cardiovascular safety analyses from the Phase III clinical program of roxadustat for the treatment of ane. 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. 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. This trial (FGCL-4592-806) was a randomized, open-label, active-controlled, phase 3 trial evaluating the efficacy and safety of roxadustat ⦠Two phase 3 clinical trials have verified the efficacy and safety of roxadustate as therapy for anemia in ⦠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. Roxadustat also advanced into Phase I clinical trials in that same year. In clinical trials ⦠FG-4592-082 (Roxadustat) Clinical Trial Open to Recruitment 16 Sep. 2019. Thus, the structural features of roxadustat might affect thyroid hormone dynamics. 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 Clinical trials are research studies that involve people. 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. Talk to your doctor for help in deciding if one is right for you. Research FOR Patients-For an informed and empowered opinion-All the trials listed in our site have been properly vetted for ⦠Clinical trials look at new ways to prevent, detect, or treat disease. 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 ⦠There are currently more than 15 phase 3 clinical trials worldwide assessing the efficacy and safety of roxadustat in CKD patients with anemia. 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. 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. 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 Clinical Trials, 43 Results, Page 1. In addition, ... FG-4592-082 (Roxadustat) Clinical Trial Open to Recruitment. Clinical trials look at new ways to prevent, detect, or treat disease. The clinical trials on this list are studying Roxadustat. Roxadustat is an orally bioavailable, hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), with potential anti-anemic activity. Roxadustat is also in clinical development for anemia associated with MDS and for chemotherapy-induced anemia. AstraZenecaâs investigational anaemia treatment, roxadustat, has proved successful in two Phase III trials that evaluated the efficacy and safety of the drug. The clinical trials on this list are studying Roxadustat. Home » FG-4592-082 (Roxadustat) Clinical Trial Open to Recruitment. 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. 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. 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 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. All trials on the list are supported by NCI. The study was conducted at 163 sites in the United States, South America, Australia, New Zealand, and Asia. Clinical trials are research studies that involve people. 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. 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. You may want to think about taking part in a clinical trial. The NDA for roxadustat is based on positive results from a global Phase 3 program encompassing more than 8,000 patients. Roxadustat also improved Hb levels from baseline in a subgroup of patients with elevated high-sensitivity C-reactive protein (hsCRP) levels of greater ⦠Roxadustat, the first small-molecule HIF-PHD inhibitor, has completed the phase 3 trials.