Trial Outcomes & Findings for Study of Roxadustat Conversion in Participants Receiving Stable Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis Participants (NCT NCT04410198)
NCT ID: NCT04410198
Last Updated: 2022-09-13
Results Overview
Percentage of participants with mean Hb value ≥10 g/dL, averaged from Week 16 through Week 24 has been reported. 95% confidence interval (CI) was calculated based on the normal approximation to the binomial distribution.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
203 participants
Primary outcome timeframe
Week 16 through Week 24
Results posted on
2022-09-13
Participant Flow
Participant milestones
| Measure |
Roxadustat
Participants received roxadustat as an oral tablet, 3 times per week (TIW) for up to a maximum of 24 weeks. If a participant required roxadustat \<60 milligrams (mg)/week to maintain hemoglobin (Hb) levels, the dose frequency was reduced in a stepwise manner, for example, to twice weekly (BIW), and then once weekly (QW). For participants converted from continuous erythropoietin receptor activator (CERA), the initial roxadustat dose was based on the average prescribed CERA dose in the last 8 weeks prior to conversion. For participants with \<6 weeks of prior CERA use, the initial roxadustat dose was based on a 2-tiered, weight-based dosing scheme. Dose adjustment evaluations were made every 4 weeks and doses were titrated based on Hb level and rate of Hb change. The prescribed dose did not exceed the maximum allowable dose of 3.0 mg/kilogram (kg)/dose or 400 mg per dose, whichever was lower.
|
|---|---|
|
Overall Study
STARTED
|
203
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
203
|
|
Overall Study
Full Analysis Set
|
201
|
|
Overall Study
COMPLETED
|
166
|
|
Overall Study
NOT COMPLETED
|
37
|
Reasons for withdrawal
| Measure |
Roxadustat
Participants received roxadustat as an oral tablet, 3 times per week (TIW) for up to a maximum of 24 weeks. If a participant required roxadustat \<60 milligrams (mg)/week to maintain hemoglobin (Hb) levels, the dose frequency was reduced in a stepwise manner, for example, to twice weekly (BIW), and then once weekly (QW). For participants converted from continuous erythropoietin receptor activator (CERA), the initial roxadustat dose was based on the average prescribed CERA dose in the last 8 weeks prior to conversion. For participants with \<6 weeks of prior CERA use, the initial roxadustat dose was based on a 2-tiered, weight-based dosing scheme. Dose adjustment evaluations were made every 4 weeks and doses were titrated based on Hb level and rate of Hb change. The prescribed dose did not exceed the maximum allowable dose of 3.0 mg/kilogram (kg)/dose or 400 mg per dose, whichever was lower.
|
|---|---|
|
Overall Study
Death
|
10
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Transferred/Relocation
|
4
|
|
Overall Study
Kidney Transplant
|
9
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Other than specified
|
1
|
Baseline Characteristics
Here, Number analyzed = Participants evaluable for this baseline measure.
Baseline characteristics by cohort
| Measure |
Roxadustat
n=203 Participants
Participants received roxadustat as an oral tablet, TIW for up to a maximum of 24 weeks. If a participant required roxadustat \<60 mg/week to maintain Hb levels, the dose frequency was reduced in a stepwise manner, for example, to BIW, and then QW. For participants converted from CERA, the initial roxadustat dose was based on the average prescribed CERA dose in the last 8 weeks prior to conversion. For participants with \<6 weeks of prior CERA use, the initial roxadustat dose was based on a 2-tiered, weight-based dosing scheme. Dose adjustment evaluations were made every 4 weeks and doses were titrated based on Hb level and rate of Hb change. The prescribed dose did not exceed the maximum allowable dose of 3.0 mg/kg/dose or 400 mg per dose, whichever was lower.
|
|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 14.13 • n=203 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=203 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=203 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=203 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
168 Participants
n=203 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=203 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
84 Participants
n=203 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
3 Participants
n=203 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
4 Participants
n=203 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
3 Participants
n=203 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
105 Participants
n=203 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
4 Participants
n=203 Participants
|
|
Baseline Hb
|
10.402 grams (g)/deciliter (dL)
STANDARD_DEVIATION 0.8159 • n=202 Participants • Here, Number analyzed = Participants evaluable for this baseline measure.
|
PRIMARY outcome
Timeframe: Week 16 through Week 24Population: The full analysis set included all enrolled participants who provided baseline Hb data and data for at least 1 postbaseline Hb time point.
Percentage of participants with mean Hb value ≥10 g/dL, averaged from Week 16 through Week 24 has been reported. 95% confidence interval (CI) was calculated based on the normal approximation to the binomial distribution.
Outcome measures
| Measure |
Roxadustat
n=201 Participants
Participants received roxadustat as an oral tablet, TIW for up to a maximum of 24 weeks. If a participant required roxadustat \<60 mg/week to maintain Hb levels, the dose frequency was reduced in a stepwise manner, for example, to BIW, and then QW. For participants converted from CERA, the initial roxadustat dose was based on the average prescribed CERA dose in the last 8 weeks prior to conversion. For participants with \<6 weeks of prior CERA use, the initial roxadustat dose was based on a 2-tiered, weight-based dosing scheme. Dose adjustment evaluations were made every 4 weeks and doses were titrated based on Hb level and rate of Hb change. The prescribed dose did not exceed the maximum allowable dose of 3.0 mg/kg/dose or 400 mg per dose, whichever was lower.
|
|---|---|
|
Percentage of Participants With Mean Hb Value ≥10 g/dL
|
84.7 percentage of participants
Interval 79.1 to 90.2
|
PRIMARY outcome
Timeframe: Baseline, Weeks 16-24Population: The full analysis set included all enrolled participants who provided baseline Hb data and data for at least 1 postbaseline Hb time point.
Baseline Hb was defined as the mean of available central laboratory Hb values prior to first dose of study medication including the predose Hb value collected on Day 1. Missing data was imputed using Monte Carlo Markov Chain (MCMC) imputation model.
Outcome measures
| Measure |
Roxadustat
n=201 Participants
Participants received roxadustat as an oral tablet, TIW for up to a maximum of 24 weeks. If a participant required roxadustat \<60 mg/week to maintain Hb levels, the dose frequency was reduced in a stepwise manner, for example, to BIW, and then QW. For participants converted from CERA, the initial roxadustat dose was based on the average prescribed CERA dose in the last 8 weeks prior to conversion. For participants with \<6 weeks of prior CERA use, the initial roxadustat dose was based on a 2-tiered, weight-based dosing scheme. Dose adjustment evaluations were made every 4 weeks and doses were titrated based on Hb level and rate of Hb change. The prescribed dose did not exceed the maximum allowable dose of 3.0 mg/kg/dose or 400 mg per dose, whichever was lower.
|
|---|---|
|
Mean Hb Change From Baseline to Average Hb From Weeks 16-24
|
0.46 g/dL
Standard Deviation 1.007
|
Adverse Events
Roxadustat
Serious events: 52 serious events
Other events: 34 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Roxadustat
n=203 participants at risk
Participants received roxadustat as an oral tablet, TIW for up to a maximum of 24 weeks. If a participant required roxadustat \<60 mg/week to maintain Hb levels, the dose frequency was reduced in a stepwise manner, for example, to BIW, and then QW. For participants converted from CERA, the initial roxadustat dose was based on the average prescribed CERA dose in the last 8 weeks prior to conversion. For participants with \<6 weeks of prior CERA use, the initial roxadustat dose was based on a 2-tiered, weight-based dosing scheme. Dose adjustment evaluations were made every 4 weeks and doses were titrated based on Hb level and rate of Hb change. The prescribed dose did not exceed the maximum allowable dose of 3.0 mg/kg/dose or 400 mg per dose, whichever was lower.
|
|---|---|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
2.0%
4/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
1.5%
3/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Angina unstable
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Bradycardia
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Vitritis
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Food poisoning
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
General disorders
Asthenia
|
1.5%
3/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
General disorders
Death
|
0.99%
2/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
General disorders
Catheter site haemorrhage
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
General disorders
Hypothermia
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
General disorders
Medical device site haemorrhage
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
General disorders
Pain
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19
|
2.5%
5/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
2.0%
4/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Sepsis
|
2.0%
4/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Arteriovenous graft site infection
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Atypical pneumonia
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Bacteraemia
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Coronavirus infection
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Endophthalmitis
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Gangrene
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Osteomyelitis
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Septic shock
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Vascular access malfunction
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Vascular access steal syndrome
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Investigations
Haemoglobin decreased
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.5%
3/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.99%
2/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Syncope
|
0.99%
2/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Brain injury
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Encephalopathy
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Neurotoxicity
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Post cardiac arrest syndrome
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Seizure
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Spinal cord infarction
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Status epilepticus
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Product Issues
Device malfunction
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Bipolar disorder
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Mental status changes
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Azotaemia
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypotension
|
0.99%
2/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Haematoma
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertensive emergency
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertensive urgency
|
0.49%
1/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Roxadustat
n=203 participants at risk
Participants received roxadustat as an oral tablet, TIW for up to a maximum of 24 weeks. If a participant required roxadustat \<60 mg/week to maintain Hb levels, the dose frequency was reduced in a stepwise manner, for example, to BIW, and then QW. For participants converted from CERA, the initial roxadustat dose was based on the average prescribed CERA dose in the last 8 weeks prior to conversion. For participants with \<6 weeks of prior CERA use, the initial roxadustat dose was based on a 2-tiered, weight-based dosing scheme. Dose adjustment evaluations were made every 4 weeks and doses were titrated based on Hb level and rate of Hb change. The prescribed dose did not exceed the maximum allowable dose of 3.0 mg/kg/dose or 400 mg per dose, whichever was lower.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
15/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19
|
5.4%
11/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
12/203 • Baseline up to 28 days post last dose of roxadustat (Week 28)
The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The multisite consortium can publish any time after the data is collected and analyzed by FibroGen. The investigator can only publish after the multisite consortium publishes (or tries to publish and fails). FibroGen has 60 days to review a publication and can extend the embargo up to an additional 120 days (or 180 total).
- Publication restrictions are in place
Restriction type: OTHER