Trial Outcomes & Findings for Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants (NCT NCT04484857)
NCT ID: NCT04484857
Last Updated: 2022-07-26
Results Overview
Percentage of participants with mean Hb value ≥10 g/dL, averaged from Week 16 through Week 24 has been reported. 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. 95% confidence interval (CI) was calculated based on the normal approximation to the binomial distribution.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
283 participants
Primary outcome timeframe
Week 16 through Week 24
Results posted on
2022-07-26
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 an erythropoiesis stimulating agent (ESA), the initial roxadustat dose was based on the average prescribed ESA dose in the last 4 weeks (for epoetin alfa and darbepoetin alfa) or 8 weeks (for methoxy polyethylene glycol-epoetin beta \[Mircera®\]). For participants with \<6 weeks of prior ESA 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
|
283
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
283
|
|
Overall Study
Full Analysis Set
|
282
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
247
|
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 an erythropoiesis stimulating agent (ESA), the initial roxadustat dose was based on the average prescribed ESA dose in the last 4 weeks (for epoetin alfa and darbepoetin alfa) or 8 weeks (for methoxy polyethylene glycol-epoetin beta \[Mircera®\]). For participants with \<6 weeks of prior ESA 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
Adverse Event
|
2
|
|
Overall Study
Death
|
10
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Transferred/Relocation
|
5
|
|
Overall Study
Kidney Transplant
|
7
|
|
Overall Study
Other than specified
|
4
|
|
Overall Study
Participants continued an Optional Extension of Roxadustat Treatment
|
216
|
Baseline Characteristics
Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants
Baseline characteristics by cohort
| Measure |
Roxadustat
n=283 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 an ESA, the initial roxadustat dose was based on the average prescribed ESA dose in the last 4 weeks (for epoetin alfa and darbepoetin alfa) or 8 weeks (for Mircera®). For participants with \<6 weeks of prior ESA 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
|
59.0 years
STANDARD_DEVIATION 13.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
167 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
91 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
191 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
113 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
131 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
2 Participants
n=5 Participants
|
|
Baseline Hb
|
10.554 grams (g)/deciliter (dL)
STANDARD_DEVIATION 0.7228 • n=5 Participants
|
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. 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. 95% confidence interval (CI) was calculated based on the normal approximation to the binomial distribution.
Outcome measures
| Measure |
Roxadustat
n=282 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 an ESA, the initial roxadustat dose was based on the average prescribed ESA dose in the last 4 weeks (for epoetin alfa and darbepoetin alfa) or 8 weeks (for Mircera®). For participants with \<6 weeks of prior ESA 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
|
83.7 percentage of participants
Interval 78.9 to 88.6
|
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=282 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 an ESA, the initial roxadustat dose was based on the average prescribed ESA dose in the last 4 weeks (for epoetin alfa and darbepoetin alfa) or 8 weeks (for Mircera®). For participants with \<6 weeks of prior ESA 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
|
0.22 g/dL
Standard Deviation 1.029
|
Adverse Events
Roxadustat
Serious events: 82 serious events
Other events: 19 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Roxadustat
n=283 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 an ESA, the initial roxadustat dose was based on the average prescribed ESA dose in the last 4 weeks (for epoetin alfa and darbepoetin alfa) or 8 weeks (for Mircera®). For participants with \<6 weeks of prior ESA 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
Anaemia
|
0.35%
1/283 • 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
|
2.5%
7/283 • 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
|
1.8%
5/283 • 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
|
1.4%
4/283 • 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 acute
|
0.71%
2/283 • 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 disease
|
0.71%
2/283 • 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
|
0.35%
1/283 • 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
|
0.35%
1/283 • 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
Atrioventricular block complete
|
0.35%
1/283 • 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
Cardiogenic shock
|
0.35%
1/283 • 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 stenosis
|
0.35%
1/283 • 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
Mitral valve incompetence
|
0.35%
1/283 • 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
Myocardial infarction
|
0.35%
1/283 • 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
Pulseless electrical activity
|
0.35%
1/283 • 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
Orbital haematoma
|
0.35%
1/283 • 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
Upper gastrointestinal haemorrhage
|
0.71%
2/283 • 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
Abdominal discomfort
|
0.35%
1/283 • 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
Abdominal pain
|
0.35%
1/283 • 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
Colitis
|
0.35%
1/283 • 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
Duodenitis
|
0.35%
1/283 • 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
Gastritis
|
0.35%
1/283 • 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
|
0.35%
1/283 • 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
Haemorrhoids
|
0.35%
1/283 • 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
|
0.35%
1/283 • 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
Rectal haemorrhage
|
0.35%
1/283 • 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
|
0.35%
1/283 • 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
Non-cardiac chest pain
|
0.71%
2/283 • 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
General physical health deterioration
|
0.35%
1/283 • 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
Organ failure
|
0.35%
1/283 • 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
Treatment noncompliance
|
0.35%
1/283 • 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.
|
|
Hepatobiliary disorders
Haemorrhagic hepatic cyst
|
0.35%
1/283 • 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.
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.35%
1/283 • 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
|
3.5%
10/283 • 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%
7/283 • 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
|
1.8%
5/283 • 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
Urinary tract infection
|
1.8%
5/283 • 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
|
0.71%
2/283 • 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
|
0.35%
1/283 • 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
Bone abscess
|
0.35%
1/283 • 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
|
0.35%
1/283 • 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
Diabetic foot infection
|
0.35%
1/283 • 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
Enterobacter sepsis
|
0.35%
1/283 • 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
Enterococcal infection
|
0.35%
1/283 • 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
Escherichia infection
|
0.35%
1/283 • 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
|
0.35%
1/283 • 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
Helicobacter infection
|
0.35%
1/283 • 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
Herpes zoster
|
0.35%
1/283 • 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
Pseudomonal bacteraemia
|
0.35%
1/283 • 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
Pyelonephritis
|
0.35%
1/283 • 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
Pyelonephritis acute
|
0.35%
1/283 • 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
|
0.35%
1/283 • 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
Skin infection
|
0.35%
1/283 • 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
|
1.1%
3/283 • 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
|
0.71%
2/283 • 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 thrombosis
|
0.35%
1/283 • 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 graft site pseudoaneurysm
|
0.35%
1/283 • 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 graft thrombosis
|
0.35%
1/283 • 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
Concussion
|
0.35%
1/283 • 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
Postoperative respiratory failure
|
0.35%
1/283 • 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
Skin laceration
|
0.35%
1/283 • 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
Toxicity to various agents
|
0.35%
1/283 • 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
Upper limb fracture
|
0.35%
1/283 • 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 site pain
|
0.35%
1/283 • 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
|
2.1%
6/283 • 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
|
1.1%
3/283 • 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
|
0.71%
2/283 • 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
Hypervolaemia
|
0.35%
1/283 • 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
Cervical spinal stenosis
|
0.35%
1/283 • 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
Pain in extremityvvv
|
0.35%
1/283 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.35%
1/283 • 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
Cerebrovascular accident
|
0.71%
2/283 • 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
Basal ganglia haemorrhage
|
0.35%
1/283 • 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
Dysarthria
|
0.35%
1/283 • 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
|
0.35%
1/283 • 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
Ischaemic stroke
|
0.35%
1/283 • 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
|
0.35%
1/283 • 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
Confusional state
|
0.35%
1/283 • 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
|
0.35%
1/283 • 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
|
0.35%
1/283 • 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
Hydroureter
|
0.35%
1/283 • 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.
|
|
Reproductive system and breast disorders
Scrotal swelling
|
0.35%
1/283 • 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
|
3.2%
9/283 • 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
|
1.8%
5/283 • 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
Pleural effusion
|
1.4%
4/283 • 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
|
1.1%
3/283 • 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 oedema
|
0.71%
2/283 • 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 pulmonary oedema
|
0.35%
1/283 • 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
Chronic obstructive pulmonary disease
|
0.35%
1/283 • 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
|
0.35%
1/283 • 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
|
0.35%
1/283 • 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
Diabetic foot
|
0.35%
1/283 • 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
|
0.35%
1/283 • 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.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.35%
1/283 • 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
|
1.8%
5/283 • 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
|
1.4%
4/283 • 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
|
1.1%
3/283 • 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
Hypertension
|
0.71%
2/283 • 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
Deep vein thrombosis
|
0.35%
1/283 • 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
Embolism
|
0.35%
1/283 • 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
Peripheral vascular disorder
|
0.35%
1/283 • 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=283 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 an ESA, the initial roxadustat dose was based on the average prescribed ESA dose in the last 4 weeks (for epoetin alfa and darbepoetin alfa) or 8 weeks (for Mircera®). For participants with \<6 weeks of prior ESA 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.
|
|---|---|
|
Infections and infestations
COVID-19
|
6.7%
19/283 • 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