Effects of vadadustat: A Synthesis of Findings from 26 Studies

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Original Abstract of the Article

Major Research Findings

Vadadustat, an oral hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor, has shown promising results in treating anemia in patients with chronic kidney disease (CKD) who are not undergoing dialysis. 19 Studies have indicated that vadadustat can effectively increase hemoglobin levels and improve iron utilization, while potentially being better tolerated than traditional injectable erythropoiesis-stimulating agents (ESAs). 18 Furthermore, research suggests that vadadustat might have a role in slowing down CKD progression. 13

Benefits and Risks

Benefits Summary

Potential benefits of vadadustat for treating anemia in CKD patients include:

  • Increased hemoglobin levels
  • Improved iron utilization
  • Lower incidence of side effects
  • Potential to slow CKD progression

Risks Summary

Potential risks associated with vadadustat include:

  • Diarrhea
  • Increased risk of adverse events leading to treatment withdrawal
  • Potential increased risk of cardiovascular events
  • Potential to promote tumor growth

Comparison between Studies

Commonalities between Studies

Multiple studies have shown that vadadustat is an effective and safe treatment option for anemia in CKD patients, potentially offering advantages over traditional ESAs. 25 11 2 23 6 3 5

Differences between Studies

Some research suggests that vadadustat might be associated with a higher risk of cardiovascular events compared to ESAs. 6 However, other studies haven't found a significant difference in cardiovascular risk between vadadustat and ESAs. 25

Consistency and Inconsistencies of Findings

While numerous studies consistently show that vadadustat is effective and safe for treating anemia in CKD patients, there is some inconsistency regarding its cardiovascular risk. Further research is needed to clarify this aspect.

Application to Real-Life Scenarios: Points to Consider

Vadadustat holds the potential to be a viable treatment option for anemia in CKD patients. However, considering the inconsistent findings regarding cardiovascular risk, it's important to weigh this potential risk when deciding to use vadadustat. 10

Limitations of Current Research

The research on vadadustat is still ongoing, and further studies are required to comprehensively assess its long-term safety and further evaluate cardiovascular risk.

Future Research Directions

Larger-scale clinical trials are needed to evaluate the long-term safety of vadadustat. Additional research is essential to clarify its cardiovascular risk profile. Further research is also needed to definitively determine vadadustat's impact on CKD progression.

Conclusion

Vadadustat shows potential as a valuable treatment option for anemia in CKD patients, offering advantages over traditional ESAs. However, its cardiovascular risk profile requires further investigation, and the long-term safety needs to be established through larger-scale clinical trials.

Literature analysis of 26 papers
Positive Content
26
Neutral Content
0
Negative Content
0
Article Type
6
3
0
5
26
1.

Effects of vadadustat on hemoglobin concentrations in patients receiving hemodialysis previously treated with erythropoiesis-stimulating agents.

Author: HaaseVolker H, ChertowGlenn M, BlockGeoffrey A, PergolaPablo E, deGomaEmil M, KhawajaZeeshan, SharmaAmit, MaroniBradley J, McCulloughPeter A

Maintained Hb concentrations
Diarrhea
Nausea
Vomiting

Vadadustat maintained mean hemoglobin concentrations in subjects on hemodialysis previously receiving epoetin. These data support further investigation of vadadustat to assess its long-term safety and efficacy in subjects on hemodialysis.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

2.

Efficacy and safety of vadadustat compared with darbepoetin alfa in Japanese anemic patients on hemodialysis: a Phase 3, multicenter, randomized, double-blind study.

Author: NangakuMasaomi, KondoKazuoki, UetaKiichiro, KokadoYoshimasa, KanekoGenki, MatsudaHiroki, KawaguchiYutaka, KomatsuYasuhiro

Effective treatment
Well-tolerated

Vadadustat was as effective and well-tolerated as darbepoetin alfa in maintaining hemoglobin (Hb) levels within the target range in Japanese anemic patients on hemodialysis.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

A phase 3, open-label, single-arm study of vadadustat for anemia in chronic kidney disease for Japanese patients on hemodialysis not receiving erythropoiesis-stimulating agents.

Author: NangakuMasaomi, KondoKazuoki, TakabeSouichirou, UetaKiichiro, TandaiTsubasa, KawaguchiYutaka, KomatsuYasuhiro

Anemia treatment
Hb increase
Diarrhea
Shunt stenosis
Vomiting

This study evaluated the efficacy and safety of vadadustat, a new drug for treating anemia in patients with chronic kidney disease (CKD), in Japanese patients on dialysis who were not receiving other anemia treatments. The study found that vadadustat effectively increased and maintained hemoglobin levels within the target range and was generally well-tolerated. While shunt stenosis was the most common side effect, it was mild and manageable.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

5.

Vadadustat for anemia in chronic kidney disease patients on peritoneal dialysis: A phase 3 open-label study in Japan.

Author: NangakuMasaomi, KondoKazuoki, TakabeSouichirou, UetaKiichiro, KanekoGenki, OtsukaMakiko, KawaguchiYutaka, KomatsuYasuhiro

Effective Hb control
Well-tolerated
Catheter site infections

This phase 3 study evaluated the efficacy and safety of vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for the treatment of anemia in Japanese CKD patients undergoing peritoneal dialysis. Vadadustat was well-tolerated and effective in controlling hemoglobin levels within the target range.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

6.

Safety and Efficacy of Vadadustat for Anemia in Patients Undergoing Dialysis.

Author: EckardtKai-Uwe, AgarwalRajiv, AswadAhmad, AwadAhmed, BlockGeoffrey A, BacciMarcelo R, FaragYoussef M K, FishbaneSteven, HubertHarold, JardineAlan, KhawajaZeeshan, KouryMark J, MaroniBradley J, MatsushitaKunihiro, McCulloughPeter A, LewisEldrin F, LuoWenli, ParfreyPatrick S, PergolaPablo, SarnakMark J, SpinowitzBruce, TumlinJames, VargoDennis L, WaltersKimberly A, WinkelmayerWolfgang C, WittesJanet, ZwiechRafal, ChertowGlenn M

Cardiovascular safety
Hemoglobin correction

Vadadustat was compared to darbepoetin alfa in two phase 3 trials for the treatment of anemia in patients with dialysis-dependent chronic kidney disease (DD-CKD). Vadadustat was noninferior to darbepoetin alfa with respect to cardiovascular safety and correction and maintenance of hemoglobin concentrations.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Equivalence TrialA clinical trial designed to show that a new treatment is equivalent in efficacy/safety to an existing treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Effect of Moderate Hepatic Impairment on the Pharmacokinetics of Vadadustat, an Oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor.

Author: ChavanAjit, BurkeLeontia, SawantRishikesh, Navarro-GonzalesPamela, VargoDennis, PaulsonSusan K

Treat anemia

Vadadustat is a drug in development for the treatment of anemia in people with chronic kidney disease. A study in adults with moderate liver problems found that the drug was safe and well tolerated. While the drug was found to have higher levels in the blood of people with liver problems, these levels were not concerning and should not affect how the drug works.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

8.

Overall Adverse Event Profile of Vadadustat versus Darbepoetin Alfa for the Treatment of Anemia Associated with Chronic Kidney Disease in Phase 3 Trials.

Author: AgarwalRajiv, AnandSanjeev, EckardtKai-Uwe, LuoWenli, ParfreyPatrick S, SarnakMark J, SolinskyChristine M, VargoDennis L, WinkelmayerWolfgang C, ChertowGlenn M

CKD anemia treatment
Cardiovascular events
Mortality

This study explores the potential benefits of vadadustat, an orally active hypoxia-inducible factor prolyl hydroxylase inhibitor, for the treatment of anemia in patients with chronic kidney disease (CKD). Vadaustat may offer advantages over erythropoiesis-stimulating agents due to its oral administration and potential for improved safety.

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

9.

Vadadustat in Patients with Anemia and Non-Dialysis-Dependent CKD.

Author: ChertowGlenn M, PergolaPablo E, FaragYoussef M K, AgarwalRajiv, ArnoldSusan, BakoGabriel, BlockGeoffrey A, BurkeSteven, CastilloFausto P, JardineAlan G, KhawajaZeeshan, KouryMark J, LewisEldrin F, LinTim, LuoWenli, MaroniBradley J, MatsushitaKunihiro, McCulloughPeter A, ParfreyPatrick S, Roy-ChaudhuryPrabir, SarnakMark J, SharmaAmit, SpinowitzBruce, TsengCarol, TumlinJames, VargoDennis L, WaltersKimberly A, WinkelmayerWolfgang C, WittesJanet, EckardtKai-Uwe,

Hematologic efficacy
Red-cell production
Cardiovascular safety

Vadadustat was compared to darbepoetin alfa in two phase 3 trials for the treatment of anemia in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD). Vadadustat was noninferior to darbepoetin alfa for hematologic efficacy but did not meet the prespecified noninferiority criterion for cardiovascular safety.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

11.

Safety and Efficacy of Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitors vs. Erythropoietin-Stimulating Agents in Treating Anemia in Renal Patients (With or Without Dialysis): A Meta-Analysis and Systematic Review.

Author: DamarlapallyNanush, ThimmappaVijaylaxmi, IrfanHamza, SikandariMuhammad, MadhuKrupa, DesaiAayushi, PavaniPeddi, ZakirSyeda, GuptaManvi, KhosaMaha Mushtaq, KotakSohny, VarrassiGiustino, KhatriMahima, KumarSatesh

Decreased iron usage
Increased Hb levels
Renal anemia treatment
Adverse events leading to withdrawal
Diarrhea

This meta-analysis compared the safety and efficacy of hypoxia-inducible factor-prolyl hydroxylase domain inhibitors (HIF-PHIs) with erythropoiesis-stimulating agents (ESAs) for treating renal anemia in patients with chronic kidney disease (CKD), finding that HIF-PHIs offer a potentially safer and more effective alternative.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

12.

A network meta-analysis of the efficacy of hypoxia-inducible factor prolyl-hydroxylase inhibitors in dialysis chronic kidney disease.

Author: ChenJun, ShouXinyang, XuYanyan, JinLie, ZhuChaoyong, YeXiaolan, MeiZiwei, ChenPeipei

Treats anemia

This study reviewed randomized controlled trials (RCTs) comparing the benefits and risks of HIF-PHIs (hypoxia-inducible factor prolyl hydroxylase inhibitors) and ESAs (erythropoiesis-stimulating agents) for anemia treatment in dialysis CKD patients.

Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

13.

Amelioration of chronic kidney disease-associated anemia by vadadustat in mice is not dependent on erythroferrone.

Author: HanudelMark R, WongShirley, JungGrace, QiaoBo, GabayanVictoria, ZukAnna, GanzTomas

Hemoglobin increase
Iron mobilization
Kidney function improvement

This study investigated the dependence of vadadustat's effects on erythropoiesis and iron metabolism on erythroferrone (ERFE).

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

14.

Segmental analysis and long-term monitoring of vadadustat in equine hair for the purpose of doping control.

Author: IshiiHideaki, ShibuyaMariko, KusanoKanichi, SoneYu, KamiyaTakahiro, WakunoAi, ItoHideki, MiyataKenji, YamadaMasayuki, LeungGary Ngai-Wa

Anti-anemia effects
Erythropoietic effects
Doping control

Vadadustat, a hypoxia-inducible factor stabilizer used for treating anemia in horses, can be detected in horse hair up to 6 months after administration. This extended detection window has implications for doping control and the interpretation of positive doping cases in equine sports.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

16.

Prolyl-hydroxylase inhibitors reconstitute tumor blood vessels in mice.

Author: NishideShunji, UchidaJunji, MatsunagaShinji, TokudomeKentaro, YamaguchiTakehiro, KabeiKazuya, MoriyaTaiki, MiuraKatsuyuki, NakataniTatsuya, TomitaShuhei

Tumor blood vessel normalization
Tumor perfusion

Prolyl-hydroxylase (PHD) inhibitors, such as Roxadustat, Daprodustat, Molidustat, and Vadadustat, are approved for treating renal anemia and have been shown to improve tumor blood vessels and the tumor microenvironment (TME) in mouse models. This suggests that PHD inhibitors may have potential as anticancer therapies.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

17.

In Vitro and Clinical Pharmacokinetic Studies of the Effects of Iron-containing Agents on Vadadustat, an Oral Hypoxia-inducible Factor-Prolyl Hydroxylase Inhibitor.

Author: KokadoYoshimasa, KawaiKouji, NanjoTakehiro, KinoshitaShuji, KondoKazuoki

Anemia treatment
Drug interactions

This study investigated drug-drug interactions between vadadustat and oral iron supplements or iron-containing phosphate binders.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

18.

Erythropoietic effects of vadadustat in patients with anemia associated with chronic kidney disease.

Author: KouryMark J, AgarwalRajiv, ChertowGlenn M, EckardtKai-Uwe, FishbaneSteven, GanzTomas, HaaseVolker H, HanudelMark R, ParfreyPatrick S, PergolaPablo E, Roy-ChaudhuryPrabir, TumlinJames A, AndersRobert, FaragYoussef M K, LuoWenli, MingaTodd, SolinskyChristine, VargoDennis L, WinkelmayerWolfgang C

Improved iron availability
Increased EPO production
Increased reticulocytes

This study examines the effects of vadadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor, in treating anemia associated with chronic kidney disease (CKD) in dialysis-dependent and non-dialysis-dependent patients. The study compares vadadustat to darbepoetin alfa, an erythropoiesis-stimulating agent, and finds that vadadustat is noninferior in increasing and maintaining target hemoglobin concentrations, while also improving iron availability to erythroid cells.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

19.

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.

Author: ZhengQiyan, YangHuisheng, SunLuying, WeiRuojun, FuXinwen, WangYahui, HuangYishan, LiuYu Ning, LiuWei Jing

Increased hemoglobin
Reduced mortality

Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) are a new class of oral medications for treating anemia in chronic kidney disease (CKD). This study compared the efficacy and safety of HIF-PHIs with epoetin and darbepoetin in CKD patients with anemia not undergoing dialysis. The results showed that HIF-PHIs were effective in raising hemoglobin levels and did not significantly increase all-cause mortality. Further research is needed to evaluate the value of HIF-PHIs in clinical practice.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

20.

Mannose Binding Lectin Is Hydroxylated by Collagen Prolyl-4-hydroxylase and Inhibited by Some PHD Inhibitors.

Author: BhuteVijesh J, HarteJames, HoughtonJack W, MaxwellPatrick H

Immune defense
Microorganism detection

Mannose-binding lectin (MBL) is a key innate immune defense protein that oligomerizes to detect and opsonize microorganisms. Prolyl hydroxylation is known to affect MBL oligomerization, but the specific enzymes involved and its exact significance remain unclear.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

22.

Novel roles of HIF-PHIs in chronic kidney disease: the link between iron metabolism, kidney function, and FGF23.

Author: IkedaYasumasa

CKD treatment
HIF-PHI side effects

This study investigates the effects of vadadustat, an HIF-PHI, on iron metabolism in a chronic kidney disease mouse model.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
CommentA short article/note that provides an opinion/perspective/interpretation on a published paper/topic.

Language : English

23.

Efficacy and safety of vadadustat compared to darbepoetin alfa on anemia in patients with chronic kidney disease: a meta-analysis.

Author: HuangQiong, LiaoZhenyi, LiuXiaoyan, XiaYun, WangJing

Anemia treatment

Vadadustat is a new drug that treats anemia caused by chronic kidney disease. It is a promising new treatment option that has been shown to be effective and safe in clinical trials.

Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

24.

Vadadustat, a HIF Prolyl Hydroxylase Inhibitor, Improves Immunomodulatory Properties of Human Mesenchymal Stromal Cells.

Author: ZielniokKatarzyna, BurdzinskaAnna, KaletaBeata, ZagozdzonRadoslaw, PaczekLeszek

Immunomodulatory properties
Improved MSC therapy

This study investigated the immunomodulatory properties of mesenchymal stromal cells (MSCs) preconditioned with hypoxia-mimetic Vadadustat. Vadadustat preconditioning significantly enhanced the immunomodulatory activity of MSCs, suggesting its potential to improve the therapeutic properties of MSCs.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

25.

Vadadustat for treatment of anemia in patients with dialysis-dependent chronic kidney disease receiving peritoneal dialysis.

Author: SarnakMark J, AgarwalRajiv, BoudvilleNeil, ChowdhuryPradip C P, EckardtKai-Uwe, GonzalezCarlos R, KooiengaLaura A, KouryMark J, NtosoKwabena A, LuoWenli, ParfreyPatrick S, VargoDennis L, WinkelmayerWolfgang C, ZhangZhiqun, ChertowGlenn M

Cardiovascular safety
Hematological efficacy
Oral anemia treatment
Unclear peritoneal dialysis effects

This article discusses the use of vadadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor, as an oral alternative to injectable erythropoiesis-stimulating agents for treating anemia in patients receiving peritoneal dialysis.

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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