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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
| Astellas Pharma Inc | INDUSTRY |
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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.
This study consists of three periods:
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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 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roxadustat | Drug | Roxadustat will be administered per schedule specified in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Change in Hb Within 16 Weeks From Baseline Without Red Blood Cell (RBC) Transfusion | 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. | Baseline, up to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Hb Level From Baseline to Week 16 (Without RBC Transfusion) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Center | Los Alamitos | California | 90720 | United States | ||
| Research Center |
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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 16 weeks. The starting dose of roxadustat was 2.0 milligrams (mg)/kilogram (kg). The dose was updated with Amendment 3 (dated 22 May 2020) for newly enrolled participants by 1 level that is, from 2.0 mg/kg to 2.5 mg/kg level to achieve an improved hemoglobin (Hb) response. |
| 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 | May 22, 2020 | May 10, 2022 |
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| Baseline, Week 16 |
| Change in Hb From Baseline at Weeks 9, 13, and 16 (Without RBC Transfusion) | 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. | Baseline, Weeks 9, 13, and 16 |
| Percentage of Participants Who Achieved a ≥1 g/dL Increase in Hb From 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. | Baseline through Week 16 |
| Time to Achieve a ≥1 g/dL Increase in Hb From 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. | Baseline through Week 16 |
| Percentage of Participants Who Achieved a ≥1.5 g/dL Increase in Hb From 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. | Baseline through Week 16 |
| Percentage of Participants Who Achieved a Hematopoietic Response | 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. | Baseline through Week 16 |
| Percentage of Participants Who Achieved a ≥2 g/dL Increase in Hb From 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. | Baseline through Week 16 |
| Percentage of Participants Who Had an RBC Transfusion From Beginning of Week 5 (Day 29) to Week 16 | Week 5 to Week 16 |
| Los Angeles |
| California |
| 90024 |
| United States |
| Research Center | Torrance | California | 90505 | United States |
| Research Center | Jacksonville | Florida | 32256 | United States |
| Research Center | Plantation | Florida | 33322 | United States |
| Research Center | Fort Wayne | Indiana | 46804 | United States |
| Research Center | Ashland | Kentucky | 41101 | United States |
| Research Center | Covington | Louisiana | 70433 | United States |
| Research Center | Bethesda | Maryland | 20817 | United States |
| Research Center | Livingston | New Jersey | 07039 | United States |
| Research Center | Port Jefferson Station | New York | 11776 | United States |
| Research Center | The Bronx | New York | 10469 | United States |
| Research Center | Canton | Ohio | 44718 | United States |
| Research Center | Gettysburg | Pennsylvania | 17325 | United States |
| Research Center | Philadelphia | Pennsylvania | 19106 | United States |
| Received at Least 1 Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat (ITT) population included all participants enrolled in the roxadustat treatment period and received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Roxadustat | Participants received roxadustat as an oral tablet, TIW for up to a maximum of 16 weeks. The starting dose of roxadustat was 2.0 mg/kg. The dose was updated with Amendment 3 (dated 22 May 2020) for newly enrolled participants by 1 level that is, from 2.0 mg/kg to 2.5 mg/kg level to achieve an improved Hb response. |
| Units | Counts |
|---|---|
| Participants |
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| 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 Hemoglobin (Hb) | Mean | Standard Deviation | grams (g)/deciliter (dL) |
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| 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 | Maximum Change in Hb Within 16 Weeks From Baseline Without Red Blood Cell (RBC) Transfusion | 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. | Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period. | Posted | Mean | Standard Deviation | g/dL | Baseline, up to Week 16 |
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| Secondary | Mean Change in Hb Level From Baseline to Week 16 (Without RBC Transfusion) | 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. | Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period. | Posted | Mean | Standard Deviation | g/dL | Baseline, Week 16 |
|
| ||||||||||||||||||||||||||
| Secondary | Change in Hb From Baseline at Weeks 9, 13, and 16 (Without RBC Transfusion) | 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. | Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | Posted | Mean | Standard Deviation | g/dL | Baseline, Weeks 9, 13, and 16 |
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| Secondary | Percentage of Participants Who Achieved a ≥1 g/dL Increase in Hb From 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. | Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline through Week 16 |
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| ||||||||||||||||||||||||||
| Secondary | Time to Achieve a ≥1 g/dL Increase in Hb From 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. | Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period. | Posted | Median | 95% Confidence Interval | days | Baseline through Week 16 |
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| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a ≥1.5 g/dL Increase in Hb From 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. | Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline through Week 16 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a Hematopoietic Response | 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. | Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline through Week 16 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a ≥2 g/dL Increase in Hb From 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. | Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline through Week 16 |
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| Secondary | Percentage of Participants Who Had an RBC Transfusion From Beginning of Week 5 (Day 29) to Week 16 | Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Number | percentage of participants | Week 5 to Week 16 |
|
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Baseline up to Week 20
Safety population included all participants who took at least 1 dose of study medication.
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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 16 weeks. The starting dose of roxadustat was 2.0 mg/kg. The dose was updated with Amendment 3 (dated 22 May 2020) for newly enrolled participants by 1 level that is, from 2.0 mg/kg to 2.5 mg/kg level to achieve an improved Hb response. | 17 | 92 | 40 | 92 | 71 | 92 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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| Odynophagia | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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| Proctalgia | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 24 | Systematic Assessment |
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| Chills | General disorders | MedDRA 24 | Systematic Assessment |
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| Disease progression | General disorders | MedDRA 24 | Systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Retroperitoneal abscess | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Staphylococcal infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Delayed haemolytic transfusion reaction | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
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| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
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| Bone cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
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| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
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| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
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| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
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| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
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| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
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| Small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
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| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA 24 | Systematic Assessment |
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| Status epilepticus | Nervous system disorders | MedDRA 24 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 24 | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA 24 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 24 | Systematic Assessment |
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| Bladder pain | Renal and urinary disorders | MedDRA 24 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
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| Anoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 24 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 24 | Systematic Assessment |
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| Vena cava embolism | Vascular disorders | MedDRA 24 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 24 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 24 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 24 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 24 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 24 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 24 | Systematic Assessment |
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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 | FG4592-092Study@fibrogen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 14, 2021 | May 10, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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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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| Other |
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