18 and older, any sex, with Chemotherapy Induced Anemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum Change in Hb Within 16 Weeks From Baseline Without Red Blood Cell (RBC) TransfusionPrimary· Baseline, up to Week 16
Baseline Hb was defined as the mean of the assessments from central lab prior to first dose of the study treatment, which included up to 2 latest screening values prior to Day 1 and a value on Day 1. All central lab assessments from Day 1 to end of treatment (EOT) or early termination (ET) were included in the evaluation of this endpoint. Hb values within 4 weeks after an RBC transfusion were excluded.
Group
Value
95% CI
Roxadustat
2.47
± 1.510
Mean Change in Hb Level From Baseline to Week 16 (Without RBC Transfusion)Secondary· Baseline, Week 16
Baseline Hb was defined as the mean of the assessments from central lab prior to first dose of the study treatment, which included up to 2 latest screening values prior to Day 1 and a value on Day 1. Mean Hb during treatment was computed using the mean area-under-the-curve trapezoid method, from Day 1 to EOT or ET Hb assessment.
Group
Value
95% CI
Roxadustat
1.20
± 1.012
Change in Hb From Baseline at Weeks 9, 13, and 16 (Without RBC Transfusion)Secondary· Baseline, Weeks 9, 13, and 16
Baseline Hb was defined as the mean of the assessments from central lab prior to first dose of the study treatment, which included up to 2 latest screening values prior to Day 1 and a value on Day 1.
Change at Week 9
Group
Value
95% CI
Roxadustat
1.43
± 1.421
Change at Week 13
Group
Value
95% CI
Roxadustat
2.15
± 1.921
Change at Week 16
Group
Value
95% CI
Roxadustat
2.52
± 1.700
Percentage of Participants Who Achieved a ≥1 g/dL Increase in Hb From Baseline Through Week 16Secondary· Baseline through Week 16
The 95% confidence interval (CI) was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded.
Group
Value
95% CI
Roxadustat
82.0
72.5 – 89.4
Time to Achieve a ≥1 g/dL Increase in Hb From Baseline Through Week 16Secondary· Baseline through Week 16
Median was calculated using Kaplan-Meier product limit method. 95% CI was calculated using the method of Brookmeyer and Crowley. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion were excluded.
Group
Value
95% CI
Roxadustat
41.0
29.0 – 46.0
Percentage of Participants Who Achieved a ≥1.5 g/dL Increase in Hb From Baseline Through Week 16Secondary· Baseline through Week 16
The 95% CI was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded.
Group
Value
95% CI
Roxadustat
73.0
62.6 – 81.9
Percentage of Participants Who Achieved a Hematopoietic ResponseSecondary· Baseline through Week 16
Hematopoietic response was defined as an increase in Hb of 1.5 g/dL from baseline or attaining a Hb of 11 g/dL. The 95% CI was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded.
Group
Value
95% CI
Roxadustat
75.3
65.0 – 83.8
Percentage of Participants Who Achieved a ≥2 g/dL Increase in Hb From Baseline Through Week 16Secondary· Baseline through Week 16
The 95% CI was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded.
Group
Value
95% CI
Roxadustat
60.7
49.7 – 70.9
Percentage of Participants Who Had an RBC Transfusion From Beginning of Week 5 (Day 29) to Week 16Secondary· Week 5 to Week 16
Group
Value
95% CI
Roxadustat
14.5
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up to Week 20.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Roxadustat
Serious: 40/92 (43%)
Deaths: 17/92
Serious adverse events (53 terms)
Reaction
System
Roxadustat
Pancreatic carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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 participants receiving chemotherapy treatment for cancer.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07268807 — Effect of Roxadustat on Heart Failure Patients With Anaemia and Moderate-to-Severe Chronic Kidney Disease
· not yet recruiting
NCT07162090 — Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitors on Sarcopenia in Hemodialysis Patients
· Phase 4
· not yet recruiting
NCT05810311 — The Effect of Roxadustat on Renal Oxygenation in Diabetes Nephropathy
· Phase 2
· not yet recruiting
NCT06903559 — Roxadustat's Effect on Heart, Nutrition, and Inflammation in Hemodialysis Patients
· Phase 1, PHASE2
· recruiting
NCT06917950 — Roxadustat for Bone and Neuropsychiatric Aspects in Hemodialysis Patients
· Phase 1, PHASE2
· recruiting
Other Kyntra Bio trials
Trials by the same sponsor.
NCT06842498 — A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
· Phase 2
· recruiting
NCT04621331 — Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD
· Phase 3
· withdrawn
NCT05301517 — A Study to Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Participants Receiving Chemothe
· Phase 3
· completed
NCT04632940 — Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids in Participants With Ambulatory DMD
· Phase 3
· terminated
NCT04419558 — Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
· Phase 3
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kyntra Bio
Last refreshed: 3 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04076943.