Phase 3 N=40 Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure
Anemia · Renal Failure
Primary: Hemoglobin Concentration at 6 Months — 117; 113 g/L
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=312 Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID)
Anaemia
Primary: Mean Change From Baseline in Hemoglobin (Hgb) During Evaluation Period (Week 28 to Week 52) — 1.02; 1.12 Grams per deciliter
N/A N=441 Anemia Management in Chronic Kidney Disease Not on Dialysis Patients After the European Renal Best Practice (ERBP) Working Group Recommendations
ANEMIA
Primary: % Patients Achieving Target Hemoglobin Levels — 42.5; 35.3 percentage of participants
Phase 3 N=4 Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P)
Anaemia
Primary: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) — 2; 2; 1; 0 Participants
Phase 3 N=2,964 Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)
Anaemia · Aspergillosis, Allergic Bronchopulmonary
Primary: Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period: Non-inferiority Analysis…
Phase 2 N=22 Efficacy and Safety of Peginesatide (AF37702) in the Treatment of Anemia in Participants With Chronic Kidney Disease
Anemia · Chronic Kidney Disease · Chronic Renal Failure
Primary: Percentage of Participants Who Experienced Increase and Maintain Hemoglobin Levels (Two Consecutive Values) Greater Than or Equal to the Lower Limit of the Target Range…
Phase 2 N=15 Anemia Studies in CKD: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat- Iron (ASCEND: Fe)
Anaemia
Primary: Percentage of Fractional Oral Iron Absorption Following Treatment With Daprodustat and rhEPO — 20.64; 20.62 Percentage (%) of iron absorbed — p=0.9971
Phase 3 N=594 Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis
Anemia in Chronic Kidney Disease in Non-dialysis Patients
Primary: Percentage of Participants With a Hemoglobin (Hb) Response to Treatment at Two Consecutive Visits During the First 24 Weeks of Treatment Without Rescue Therapy Prior to…
Phase 3 N=823 Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis
Chronic Renal Failure · Chronic Kidney Disease · Anemia
Primary: Mean Change in Hemoglobin Between Baseline and the Evaluation Period — 11.20; 11.21; 11.13; 11.05 g/dL
Phase 3 N=121 Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis
Anemia
Primary: Mean Change From Baseline to the Highest Hemoglobin up to Day 71 — 1.3; .7 g/dL
Phase 3 N=3,872 Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)
Anaemia
Primary: Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period (Non-inferiority Analysis)…
Phase 3 N=803 Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis
Chronic Renal Failure · Chronic Kidney Disease · Anemia
Primary: Mean Change in Hemoglobin Between Baseline and the Evaluation Period — 11.30; 11.32; 11.06; 11.25 g/dL
Phase 3 N=836 Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis
Anemia · End Stage Renal Disease (ESRD)
Primary: Change From Baseline (BL) to the Average Hemoglobin (Hb) in Weeks 28-36 Without Rescue Therapy [EU (EMA)] — 0.428; 0.193 g/dL — p=<0.001
Phase 3 N=42 Efficacy and Safety Study to Evaluate MT-6548 in Peritoneal Dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
Anemia; Peritoneal Dialysis Dependent Chronic Kidney Disease
Primary: Mean Hb Level of Week 20 and Week 24 — 11.35 g/dL
Phase 2 N=114 Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving an ESA
Anemia · Chronic Renal Failure · Chronic Kidney Disease
Primary: Mean Change in Hemoglobin Between Baseline and the Evaluation Period — 9.34; 9.20; 9.07; 11.45 g/dL
Phase 3 N=493 Safety and Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis
Chronic Renal Failure · Chronic Kidney Disease · Anemia
Primary: Mean Change in Hemoglobin Between Baseline and the Evaluation Period — 10.02; 10.03; 10.03; 11.55 g/dL
Phase 2 N=59 Efficacy and Safety of Peginesatide Injection for the Maintenance Treatment of Anemia in Peritoneal Dialysis Participants Previously Treated With Epoetin.
Anemia
Primary: Mean Change in Hemoglobin Between Baseline and the Evaluation Period — 11.22; 11.33; 0.10 g/dL
N/A N=196 Survey on Anemia Therapy in Participants With Chronic Kidney Disease (CKD) Not on Dialysis
Chronic Kidney Diseases
Primary: Percentage of Participants by ESA Types at Baseline — 51.5; 17.3; 10.7; 20.4 percentage of participants
Phase 3 N=614 Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)
Anaemia
Primary: Mean Change in Hemoglobin From Baseline and Over the Evaluation Period (Mean Over Week 24 and 28) — 0.19; 1.58 Grams per deciliter — p=<0.0001
Phase 3 N=490 Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis
Chronic Renal Failure · Chronic Kidney Disease · Anemia
Primary: Mean Change in Hemoglobin Between Baseline and the Evaluation Period — 10.05; 9.95; 10.05; 11.47 g/dL
Phase 4 N=55 Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients
Hyperphosphatemia
Primary: Phosphorus Levels — 5.3; 5.6; 5.4; 6 mg/dL
Phase 3 N=407 Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)
Anaemia
Primary: Mean Change From Baseline in Hemoglobin Levels Over the Evaluation Period (Week 28 to Week 52) — -0.04; 0.02 Grams per deciliter (g/dL)
Phase 1 N=30 Study of Intraperitoneal Triferic in Patients on Chronic Peritoneal Dialysis
Peritoneal Dialysis (PD) · Anemia · Chronic Kidney Disease
Primary: Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Maximum Concentration (Cmax) of Serum Total Iron After Intraperitoneal…
Phase 4 N=184 Treatment Response in Dialysis Anaemia
Anaemia · Haemodialysis
Primary: Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment — 53; 61 Participants
Phase 1 N=8 Study to Assess the Pharmacokinetics of GSK1278863 in Subjects With End Stage Renal Disease Undergoing Peritoneal Dialysis
Anaemia
Primary: Area Under the Concentration-time Curve (AUC) Over the Dosing Interval (AUC[0-tau]) of GSK1278863 and Its Metabolites — 184.9863; 138.6511; 162.9366; 131.2826 Hour into…
Phase 4 N=89 Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients
Anemia, Iron-Deficiency · Kidney Failure, Chronic
Primary: Change in Hemoglobin (Hgb) — 0.6; 0.2 g/dL
Phase 3 N=146 2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.
Iron Deficiency Anemia
Primary: Hemoglobin — 1.49; 0.89; 1.02 ng/mL
Phase 3 N=96 A Study of Monthly Subcutaneous (SC) Mircera for Maintenance Treatment of Participants With Chronic Kidney Disease on Peritoneal Dialysis
Anemia
Primary: Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP — 50.0 percentage of participants
Phase 3 N=250 VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
Anemia
Primary: Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL — 87; 35 participants
Phase 4 N=52 Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents
Anemia, Iron-Deficiency · Kidney Failure, Chronic
Primary: Baseline Hemoglobin Concentration — 10.3; 10.4 g/dL