Vafseo (vadadustat)
Research Synopsis
- - Vafseo (vadadustat) is a novel oral medication designed to treat anemia associated with chronic kidney disease (CKD), specifically targeting non-dialysis-dependent and dialysis-dependent patients.
- - Recent research, including the PROTECT trials, indicates that while vadadustat shows comparable efficacy to darbepoetin alfa in improving hemoglobin levels, it presents a higher risk of serious cardiovascular issues in certain global regions, particularly in Europe and South America.
- - In phase 2 clinical trials, vadadustat demonstrated significant improvements in hemoglobin levels over placebo, with a notable minority reaching target hemoglobin levels in 6 weeks, suggesting potential as an effective treatment option.
- - A systematic review exploring HIF-PHIs indicated that vadadustat is generally well-tolerated with minimal serious adverse events, revealing that it does not significantly increase all-cause mortality among CKD patients.
- - Economic analyses suggest that treating anemia in CKD patients effectively improves health-related quality of life (HRQoL) and reduces treatment costs, advocating for the adoption of vadadustat.
- - Concerns remain about the long-term safety profile of vadadustat, especially related to cardiovascular risks, necessitating ongoing evaluation in diverse populations beyond current clinical trial settings.
- - Additional studies support the role of vadadustat in enhancing iron mobilization, unlike traditional treatments that may lead to unstable hemoglobin levels and high erythropoietin levels.
- - The partnership of Akebia Therapeutics with Mitsubishi Tanabe Pharma and Otsuka Pharmaceutical Co. aims to expedite the regulatory process for vadadustat in Japan, the USA, and the EU, highlighting its commercial importance.
- - Emerging evidence also proposes that vadadustat may enhance the immunomodulatory properties of mesenchymal stromal cells, indicating potential broader therapeutic applications beyond anemia treatment.
- - Future research efforts are expected to focus on larger, longer-term studies to clarify the safety profile and efficacy of vadadustat, especially post-approval and in real-world clinical scenarios.
Vafseo (vadadustat)
Safety Endpoints With Vadadustat Versus Darbepoetin Alfa in Patients With Non-Dialysis-Dependent CKD: A Post Hoc Regional Analysis of the PROTECT Randomized Clinical Trial of ESA-Naïve Patients.
London, UK
2 hours ago
1 Received
- The PROTECT trials studied how safe a new kidney disease treatment called vadadustat is compared to another treatment called darbepoetin alfa in patients who don't need dialysis.
- The results showed no difference in major heart-related problems among patients in the U.S., but those treated with vadadustat outside the U.S. had more issues, especially in Brazil and South Africa.
- The study included over 1,700 patients who had never been treated before, and they looked at different factors like kidney function and deaths related to kidney failure in those regions.
$100 - $150
Hourly Rate
Safety Endpoints With Vadadustat Versus Darbepoetin Alfa in Patients With NonDialysis-Dependent CKD: A Post Hoc Regional Analysis of the PROTECT Randomized Clinical Trial of ESA-Treated Patients.
London, UK
2 hours ago
1 Received
- In the PROTECT trials, a new drug called vadadustat was compared to a drug named darbepoetin alfa for treating patients with kidney disease and anemia.
- They found that while vadadustat worked similarly for improving blood health, it had more risks for serious heart problems in certain regions, especially in Europe.
- Overall, patients in Europe experienced a higher rate of heart problems compared to those in the US and other regions, suggesting location may affect treatment outcomes.
$100 - $150
Hourly Rate
Vadadustat, a novel oral HIF stabilizer, provides effective anemia treatment in nondialysis-dependent chronic kidney disease.
London, UK
2 hours ago
1 Received
- Current treatments for anemia in chronic kidney disease (CKD) can cause unstable hemoglobin levels and high erythropoietin.
- A study evaluated the effectiveness and safety of vadadustat, a new oral medication, in stages 3a to 5 CKD patients, showing significant improvement in hemoglobin levels compared to a placebo.
- Vadadustat also boosted iron mobilization and showed a similar rate of adverse events as the placebo, despite three deaths in the vadadustat group.
$100 - $150
Hourly Rate
Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors: A Potential New Treatment for Anemia in Patients With CKD.
London, UK
2 hours ago
1 Received
- Erythropoiesis-stimulating agents (ESAs) have been used since 1989 to treat anemia in chronic kidney disease (CKD) by increasing hemoglobin and reducing transfusions; however, they carry risks of cardiovascular issues and other complications.
- New HIF prolyl hydroxylase (PH) enzyme inhibitors are emerging as an alternative, working by enhancing natural erythropoietin production and improving iron availability, with the added benefit of being taken orally, which could be more convenient for patients.
- Although HIF-PH inhibitors show promise for safer blood management with fewer side effects compared to ESAs, long-term studies are needed to confirm their effects, especially concerning potential risks like tumor growth
$100 - $150
Hourly Rate
HIF-prolyl hydroxylases as therapeutic targets in erythropoiesis and iron metabolism.
London, UK
2 hours ago
1 Received
- A primary response to low oxygen levels (systemic hypoxia) is the body’s increase in red blood cell production, managed by the HIF pathway.
- The HIF pathway plays a significant role in various cellular functions, and its discovery has spurred the creation of small molecules that boost the natural production of erythropoietin and improve iron metabolism.
- This review highlights the cellular and molecular processes involved in HIF-induced production of red blood cells and discusses recent clinical findings on treatments targeting HIF-prolyl hydroxylases for treating anemia.
$100 - $150
Hourly Rate
Targeting Hypoxia-Inducible Factors for the Treatment of Anemia in Chronic Kidney Disease Patients.
London, UK
2 hours ago
1 Received
- Anemia is a common issue in chronic kidney disease (CKD), traditionally linked to low erythropoietin production, but now also associated with problems in iron metabolism and increased hepcidin activity.
- Current treatments include erythropoiesis-stimulating agents, iron supplements, and blood transfusions, but there are safety concerns, prompting the exploration of new options like targeting hypoxia-inducible factors (HIFs).
- The review highlights the HIF pathway's role in regulating erythropoiesis and iron metabolism, discussing the development and clinical trials of HIF prolyl hydroxylase inhibitors as a promising alternative for managing anemia in CKD patients.
$100 - $150
Hourly Rate
Clinical Trial of Vadadustat in Patients with Anemia Secondary to Stage 3 or 4 Chronic Kidney Disease.
London, UK
2 hours ago
1 Received
- Vadadustat is an oral medication being tested to treat anemia in patients with chronic kidney disease (CKD), particularly those in stages 3 and 4, as current treatment options are limited.
- A phase 2a clinical trial involved 93 adults who took varying doses of vadadustat or a placebo for 6 weeks, with results showing that vadadustat significantly increased hemoglobin levels compared to the placebo.
- While vadadustat improved iron metrics and did not significantly increase adverse effects, the study had limitations such as a small sample size and a short duration, leading to further phase 3 trials in more patients.
$100 - $150
Hourly Rate
Prolyl Hydroxylase Inhibitors: A Breakthrough in the Therapy of Anemia Associated with Chronic Diseases.
London, UK
2 hours ago
1 Received
- * Hypoxia triggers the production of hypoxia-inducible factor (HIF), which increases erythropoietin (EPO) levels and helps stimulate red blood cell formation.
- * Prolyl hydroxylase domain (PHD) inhibitors, which stabilize HIF and lower hepcidin levels (regulating iron), are being tested in clinical trials as a new oral treatment for anemia linked to chronic diseases, with several compounds such as roxadustat and vadadustat in advanced trial phases.
$100 - $150
Hourly Rate
Effects of vadadustat on hemoglobin concentrations in patients receiving hemodialysis previously treated with erythropoiesis-stimulating agents.
London, UK
2 hours ago
1 Received
- * In a Phase 2 trial with 94 participants, different dosing regimens of vadadustat were administered; however, no significant changes in hemoglobin levels were found during the study.
- * The drug was generally well tolerated, with 83% of participants experiencing adverse events, most commonly nausea and diarrhea, but no serious adverse events were linked to vadadustat, suggesting further research is needed.
$100 - $150
Hourly Rate
Hypoxia-Inducible Factor Activators in Renal Anemia: Current Clinical Experience.
London, UK
2 hours ago
1 Received
- * Small molecule inhibitors of these sensors, known as HIF-PHIs, can boost erythropoietin production and enhance iron metabolism, offering an effective treatment for anemia in chronic kidney disease (CKD) patients.
- * Three HIF-PHIs—daprodustat, roxadustat, and vadadustat—are currently in advanced clinical stages, with roxadustat recently approved for use in China, although ongoing discussions about the safety of long-term use
$100 - $150
Hourly Rate
Economic Burden and Health-Related Quality of Life Associated with Current Treatments for Anaemia in Patients with CKD not on Dialysis: A Systematic Review.
London, UK
2 hours ago
1 Received
- The study explores the costs and health-related quality of life (HRQoL) impacts of treating anaemia in non-dialysis-dependent (NDD) patients with chronic kidney disease (CKD).
- Researchers reviewed literature from various databases and focused on studies that involved treatments like iron supplementation or erythropoiesis-stimulating agents (ESAs) and their effects on HRQoL and costs.
- Findings indicated that treating anaemia generally improved HRQoL and reduced costs compared to no treatment, but aiming for higher hemoglobin targets resulted in modest HRQoL gains while increasing healthcare resource use and costs.
$100 - $150
Hourly Rate
Aspartate/asparagine-β-hydroxylase: a high-throughput mass spectrometric assay for discovery of small molecule inhibitors.
London, UK
2 hours ago
1 Received
- The enzyme aspartate/asparagine-β-hydroxylase (AspH) plays a key role in cancer biology by modifying specific residues in growth factor-like domains, and its higher levels are linked to increased tumor invasiveness.
- A new synthetic thioether mimic was developed to enhance high-throughput screening assays for AspH inhibition, showing reliable performance in identifying potential inhibitors.
- The study screened about 1500 small molecules to find effective AspH inhibitors, which could lead to safer and more selective treatments, including for other similar enzymes like prolyl-hydroxylase.
$100 - $150
Hourly Rate
Prolyl-hydroxylase inhibitors reconstitute tumor blood vessels in mice.
London, UK
2 hours ago
1 Received
- Tumor blood vessels are often leaky and have poor blood flow, resulting in low oxygen and nutrient levels in the tumor microenvironment (TME).
- The PHD inhibitor Roxadustat was found to normalize these blood vessels, enhance blood flow, and increase oxygen levels in tumors.
- Other PHD inhibitors like Daprodustat, Molidustat, and Vadadustat were tested and showed varying effects on tumor blood vessels in mouse models, suggesting they could improve the TME as well.
$100 - $150
Hourly Rate
Mannose Binding Lectin Is Hydroxylated by Collagen Prolyl-4-hydroxylase and Inhibited by Some PHD Inhibitors.
London, UK
2 hours ago
1 Received
- Mannose-binding lectin (MBL) is crucial for immune defense and requires oligomerization to effectively recognize and opsonize pathogens, but the role of prolyl hydroxylation in this process needs further investigation.
- Researchers expressed Myc-DDK tagged MBL in HEK293S cells and used inhibitors to pinpoint the enzyme responsible for prolyl hydroxylation, discovering that prolyl-4-hydroxylase subunit 1 is essential for MBL secretion.
- The study indicates that certain prolyl hydroxylase domain inhibitors can reduce MBL activity, suggesting the potential need for more selective inhibitors to avoid interfering with MBL production while still targeting other processes.
$100 - $150
Hourly Rate
Vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for treatment of anemia of chronic kidney disease: two randomized Phase 2 trials in Japanese patients.
London, UK
2 hours ago
1 Received
- * In clinical trials, vadadustat showed significant improvements in hemoglobin levels after 6 weeks of treatment, with a majority of patients reaching target hemoglobin levels by week 16.
- * The treatment was generally well-tolerated, with some common side effects like nausea and hypertension, and the results suggest it is a promising option for managing CKD-related anemia.
$100 - $150
Hourly Rate
Efficacy and safety of HIF prolyl-hydroxylase inhibitor vs epoetin and darbepoetin for anemia in chronic kidney disease patients not undergoing dialysis: A network meta-analysis.
London, UK
2 hours ago
1 Received
- HIF-PHIs are new oral medications designed to treat anemia in patients with chronic kidney disease (CKD) who are not on dialysis, compared against epoetin and darbepoetin.
- A review of 19 clinical trials showed that all HIF-PHIs, except for vadadustat, significantly increased hemoglobin levels compared to placebo, with no notable differences in efficacy among them.
- Additionally, there were no significant associations found between these medications and all-cause mortality, indicating they are effective and relatively safe for this patient group, although further research is needed.
$100 - $150
Hourly Rate
Vadadustat: First Approval.
London, UK
2 hours ago
1 Received
- - Vadadustat (VAFSEO) is a prolyl hydroxylase inhibitor designed to treat anemia related to chronic kidney disease (CKD), developed by Akebia Therapeutics, Inc.
- - Akebia is partnering with Mitsubishi Tanabe Pharma for development and commercialization in Japan, and with Otsuka Pharmaceutical Co. for the USA, EU, and other regions.
- - The drug is already approved in Japan for adults with CKD-related anemia, with plans for regulatory submissions in the USA and EU.
$100 - $150
Hourly Rate
Roxadustat (FG-4592) accelerates pulmonary growth, development, and function in a compensatory lung growth model.
London, UK
2 hours ago
1 Received
- Children with congenital diaphragmatic hernia (CDH) suffer from serious lung issues, leading to high rates of illness and death, especially in severe cases where current treatments have not improved in decades.* -
- A study explored the drug Roxadustat, which boosts vascular endothelial growth factor (VEGF), showing promising results in increasing lung growth and function after surgery to remove a lung.* -
- Unlike Roxadustat, another similar drug, Vadadustat, did not improve lung growth, suggesting Roxadustat's unique effects could offer a new treatment path for kids with lung disease, leveraging its existing clinical studies for faster approval.*
$100 - $150
Hourly Rate
Vadadustat, a HIF Prolyl Hydroxylase Inhibitor, Improves Immunomodulatory Properties of Human Mesenchymal Stromal Cells.
London, UK
2 hours ago
1 Received
- Mesenchymal stromal cells (MSCs) have therapeutic potential due to their ability to modulate the immune response, which can be enhanced by preconditioning them with Vadadustat under low oxygen conditions.
- The study involved analyzing gene expression in six human bone marrow-derived MSC populations after 6 hours of Vadadustat treatment, showing significant changes in the expression of immune-related genes.
- Results indicated that Vadadustat reduced the secretion of several pro-inflammatory factors and enhanced MSCs' ability to inhibit the growth of activated immune cells, suggesting it could be an effective method to boost the immunomodulatory effects of MSCs.
$100 - $150
Hourly Rate
HIF Prolyl Hydroxylase Inhibitors for COVID-19 Treatment: Pros and Cons.
London, UK
2 hours ago
1 Received
- The review discusses the potential benefits and drawbacks of using HIF prolyl hydroxylase inhibitors as a treatment option for COVID-19.
- These inhibitors can enhance the production of erythropoietin (Epo), which has anti-inflammatory and healing effects, possibly helping patients with moderate to severe symptoms.
- However, while they may address complications arising from the disease, they are not expected to be effective in preventing the initial stages of COVID-19 infection.
$100 - $150
Hourly Rate