Akebia Therapeutics — Biomedical Watch V2

Traitements5programmes

Essais2liés

Publications4liées

SourceDBlocale

Traitements

5

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
ADX-097A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 16 Years or Older with Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G)	Lupus	Phase 2	À vérifier	United States, Brazil	À vérifier
Erythropoiesis-Stimulating Agent (ESA)This is a multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the efficacy of vadadustat administered three times a week compared to standard of care erythropoiesis-stimulating agent for the treatment of anemia in in-center hemodialysis participants with end-stage kidney disease (ESKD). A subset of sites will participate in a red blood cell (RBC) sub-study where changes in the phenotype of RBCs in response to vadadustat treatment relative to methoxy polyethylene glycol-epoetin beta treatment in DD-CKD participants with anemia will be assessed. A separate informed consent form (ICF) will be signed by these participants who opt to be in the RBC sub-study. Of the 350 participants in the main study, approximately 28 participants will also be enrolled into the RBC sub-study. The total duration of the study is approximately 35 Weeks including screening and follow-up.	Maladie rénale chronique	Phase 3	À vérifier	United States	À vérifier
VadadustatThis is a multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the efficacy of vadadustat administered three times a week compared to standard of care erythropoiesis-stimulating agent for the treatment of anemia in in-center hemodialysis participants with end-stage kidney disease (ESKD). A subset of sites will participate in a red blood cell (RBC) sub-study where changes in the phenotype of RBCs in response to vadadustat treatment relative to methoxy polyethylene glycol-epoetin beta treatment in DD-CKD participants with anemia will be assessed. A separate informed consent form (ICF) will be signed by these participants who opt to be in the RBC sub-study. Of the 350 participants in the main study, approximately 28 participants will also be enrolled into the RBC sub-study. The total duration of the study is approximately 35 Weeks including screening and follow-up.	Maladie rénale chronique	Phase 3	À vérifier	United States	À vérifier
ADX-097A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 16 Years or Older with Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G)	Lupus	Phase 2	À vérifier	United States, Brazil	À vérifier
Erythropoiesis-Stimulating Agent (ESA)This is a multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the efficacy of vadadustat administered three times a week compared to standard of care erythropoiesis-stimulating agent for the treatment of anemia in in-center hemodialysis participants with end-stage kidney disease (ESKD). A subset of sites will participate in a red blood cell (RBC) sub-study where changes in the phenotype of RBCs in response to vadadustat treatment relative to methoxy polyethylene glycol-epoetin beta treatment in DD-CKD participants with anemia will be assessed. A separate informed consent form (ICF) will be signed by these participants who opt to be in the RBC sub-study. Of the 350 participants in the main study, approximately 28 participants will also be enrolled into the RBC sub-study. The total duration of the study is approximately 35 Weeks including screening and follow-up.	Maladie rénale chronique	Phase 3	À vérifier	United States	À vérifier

Essais cliniques

2

Molécule	Indication / population	Phase	NCT	Titre	Statut
Erythropoiesis-Stimulating Agent (ESA)	Maladie rénale chronique	Phase 3	NCT06901505	To Evaluate the Efficacy of Three Times Weekly (TIW) Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis	COMPLETED
ADX-097	Lupus	Phase 2	NCT06419205	A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G	RECRUITING

Publications

4

Molécule	Indication / population	Titre	Journal	Date
Erythropoiesis-Stimulating Agent (ESA)		Effect of hemoperfusion plus hemodialysis on uremic toxins and anemia in patients with maintenance hemodialysis.	Renal failure
Erythropoiesis-Stimulating Agent (ESA)		Post-transplant anemia as a persistent risk factor for graft dysfunction in kidney transplant recipients.	Renal failure
Erythropoiesis-Stimulating Agent (ESA)		Outcomes of patients with myelofibrosis treated with ruxolitinib and anemia-supporting medications.	Hematology (Amsterdam, Netherlands)
ADX-097		C3d-Targeted factor H inhibits tissue complement in disease models and reduces glomerular injury without affecting circulating complement.	Molecular therapy : the journal of the American Society of Gene Therapy