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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The purpose of this study is to assess the safety and effectiveness of Roxadustat dosing regimens among chronic dialysis participants converted from ESA therapy or who are ESA-naïve.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roxadustat | Experimental | Participants will receive roxadustat as an oral tablet, 3 times per week (TIW) for up to a maximum of 24 weeks. If a participant requires roxadustat <60 milligrams (mg)/week to maintain Hb levels, the dose frequency will be reduced in a stepwise manner, for example, to BIW, and then QW. For participants converted from CERA, the initial roxadustat dose will be 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 will be based on a 2-tiered, weight-based dosing scheme. Dose adjustment evaluations will be made every 4 weeks and doses will be titrated based on Hb level and rate of Hb change. The prescribed dose will not exceed the maximum allowable dose of 3.0 mg/kilogram (kg)/dose or 400 mg per dose, whichever is lower. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roxadustat | Drug | Roxadustat will be administered per dose and schedule specified in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Mean Hb Value ≥10 g/dL | 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. | Week 16 through Week 24 |
| Mean Hb Change From Baseline to Average Hb From Weeks 16-24 | 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. | Baseline, Weeks 16-24 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Eisner | Kyntra Bio | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Englewood | Colorado | 80110 | United States | ||
| Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 20, 2020 | Jun 24, 2022 |
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| Caldwell |
| Idaho |
| 83642 |
| United States |
| Investigational Site | Baton Rouge | Louisiana | 70808 | United States |
| Investigational Site | Kalamazoo | Michigan | 49009 | United States |
| Investigational Site | Tupelo | Mississippi | 38801 | United States |
| Investigational Site | Saint Ann | Missouri | 63074 | United States |
| Investigational Site | Las Vegas | Nevada | 89106 | United States |
| Investigational Site | Sugar Land | Texas | 77479 | United States |
| Investigational Site | St. George | Utah | 84790 | United States |
| Received at Least 1 Dose of Study Drug |
|
| Full Analysis Set | All enrolled participants who provided baseline Hb data and data for at least 1 postbaseline Hb time point. |
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| COMPLETED |
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| NOT COMPLETED |
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The safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Roxadustat | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Baseline Hb | Here, Number analyzed = Participants evaluable for this baseline measure. | Mean | Standard Deviation | grams (g)/deciliter (dL) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Mean Hb Value ≥10 g/dL | 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. | The full analysis set included all enrolled participants who provided baseline Hb data and data for at least 1 postbaseline Hb time point. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 through Week 24 |
|
|
| |||||||||||||||||||||||||
| Primary | Mean Hb Change From Baseline to Average Hb From Weeks 16-24 | 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. | The full analysis set included all enrolled participants who provided baseline Hb data and data for at least 1 postbaseline Hb time point. | Posted | Mean | Standard Deviation | g/dL | Baseline, Weeks 16-24 |
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Roxadustat | 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. | 10 | 203 | 52 | 203 | 34 | 203 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vitritis | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pancreatic pseudocyst | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pancreatitis relapsing | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Medical device site haemorrhage | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Systemic inflammatory response syndrome | General disorders | MedDRA 24.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Arteriovenous graft site infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Atypical pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Coronavirus infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Endophthalmitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Gangrene | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Staphylococcal sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Arteriovenous fistula aneurysm | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Arteriovenous fistula occlusion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Vascular access malfunction | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Vascular access steal syndrome | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperammonaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Brain injury | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Neurotoxicity | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Post cardiac arrest syndrome | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Spinal cord infarction | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Status epilepticus | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Device malfunction | Product Issues | MedDRA 24.0 | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Azotaemia | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
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).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Information Desk | FibroGen, Inc. | 415-978-1441 | FG4592-097Study@fibrogen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 9, 2021 | Jun 24, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C584543 | roxadustat |
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|
| Unknown or Not Reported |
|
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Other |
|
|
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