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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002871-40 | EudraCT Number |
Not provided
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The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HX575 epoetin alfa (Sandoz) | Experimental | Single arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HX575 epoetin alfa (Sandoz) | Drug | Eligible patients are scheduled to receive HX575 (INN: Epoetin alfa) as a solution for injection in order to achieve or maintain the correction of renal anemia. |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-Erythropoietin (EPO) Antibodies | The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study) | Actual values of hemoglobin levels at end of study visit and change from Baseline Period (Week -4 to Week -1) | 52 weeks |
Not provided
Main Inclusion Criteria:
Main Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Sandoz Biopharmaceuticals | Sandoz | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandoz Investigative Site | Düsseldorf | Germany | ||||
| Sandoz Investigative Site |
Male and female patients (ESA [Erythropoiesis Stimulating Agent]-naïve/on ESA-maintenance therapy, i.v./s.c.) aged 18 years/older, suffering from anemia assoc. with CKD, with/without dialysis treatment. Anemia: Mean Hb conc. <= 11.0 g/dL for ESA naïve, 9.0-12.0 g/dL for patients receiving ESA therapy.
Patients, suffering from anemia associated with chronic Kidney Disease (CKD), were treated s.c. with HX575 at least once per week in order to achieve and maintain Hb concentration within the target range of 10.0 to 12.0 g/dL. 417 patients were enrolled.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | HX575, Safety Population | In the single arm study, HX575 was tested as investigational medicinal product. The single arm includes ESA-naïve patients and patients on ESA-maintenance therapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Homberg (Efze) |
| Germany |
| Sandoz Investigative Site | Nettetal | Germany |
| Sandoz Investigative Site | Bari | Italy |
| Sandoz Investigative Site | Częstochowa | Poland |
| Sandoz Investigative Site | Gdansk | Poland |
| Sandoz Investigative Site | Gdynia | Poland |
| Sandoz Investigative Site | Olkusz | Poland |
| Sandoz Investigative Site | Poznan | Poland |
| Sandoz Investigative Site | Płock | Poland |
| Sandoz Investigative Site | Wadowice | Poland |
| Sandoz Investigative Site | Warzawa | Poland |
| Sandoz Investigative Site | Bucharest | Romania |
| Sandoz Investigative Site | Constanța | Romania |
| Sandoz Investigative Site | Lasi | Romania |
| Sandoz Investigative Site | Oradea | Romania |
| Sandoz Investigative Site | Timișoara | Romania |
| Sandoz Investigative Site | Chelyabinsk | Russia |
| Sandoz Investigative Site | Kemerovo | Russia |
| Sandoz Investigative Site | Kolomna | Russia |
| Sandoz Investigative Site | Moscow | Russia |
| Sandoz Investigative Site | Mytischi | Russia |
| Sandoz Investigative Site | Nizhny Novgorod | Russia |
| Sandoz Investigative Site | Novosibirsk | Russia |
| Sandoz Investigative Site | Orenburg | Russia |
| Sandoz Investigative Site | Petrozavodsk | Russia |
| Sandoz Investigative Site | Podolsk | Russia |
| Sandoz Investigative Site | Pyatigorsk | Russia |
| Sandoz Investigative Site | Ryazan | Russia |
| Sandoz Investigative Site | Saint Petersburg | Russia |
| Sandoz Investigative Site | Saratov | Russia |
| Sandoz Investigative Site | Smolensk | Russia |
| Sandoz Investigative Site | Yaroslavl | Russia |
| Sandoz Investigative Site | Yekaterinburg | Russia |
| Sandoz Investigative Site | Adana | Turkey (Türkiye) |
| Sandoz Investigative Site | Ankara | Turkey (Türkiye) |
| Sandoz Investigative Site | Istanbul | Turkey (Türkiye) |
| Sandoz Investigative Site | Chernivtsi | Ukraine |
| Sandoz Investigative Site | Dnipropetrovsk | Ukraine |
| Sandoz Investigative Site | Donetsk | Ukraine |
| Sandoz Investigative Site | Ivano-Frankivsk | Ukraine |
| Sandoz Investigative Site | Kharkiv | Ukraine |
| Sandoz Investigative Site | Kyiv | Ukraine |
| Sandoz Investigative Site | Luhansk | Ukraine |
| Sandoz Investigative Site | Mykolayiv | Ukraine |
| Sandoz Investigative Site | Poltava | Ukraine |
| Sandoz Investigative Site | Ternopil | Ukraine |
| Sandoz Investigative Site | Uzhhorod | Ukraine |
| Sandoz Investigative Site | Zaporizhya | Ukraine |
| Sandoz Investigative Site | Zhitomyr | Ukraine |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population: The safety population consists of all patients that received at least one dose of study drug
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | HX575, Safety Population | The Study was designed as single arm study with HX575 tested as investigational medicinal product. The safety population (SAF) consisted of all patients that received at least one dose of study drug. 417 patients enrolled, 416 treated. Group includes ESA-naïve patients and patients on ESA-maintenance therapy. |
| 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 |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| ||||||||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| ||||||||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||||||||||
| ESA pre-treatment | A patient is considered to be ESA naïve if the patient did not receive any ESA therapy within 2 months prior to first screening visit. | Number | participants |
|
| 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 | Anti-Erythropoietin (EPO) Antibodies | The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay | Safety population: The safety population consists of all patients that received at least one dose of study drug | Posted | Number | 95% Confidence Interval | percentage of participants | 52 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study) | Actual values of hemoglobin levels at end of study visit and change from Baseline Period (Week -4 to Week -1) | Per-protocol population (all patients that received at least one dose of study drug) with non-missing Hemoglobin value at Visit 16 (end of study). | Posted | Mean | Standard Deviation | g/dL | 52 weeks |
|
4 weeks (screening period) + 52 weeks (treatment period)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HX575, Safety Population | Study was designed as single arm study with HX575 tested as investigational medicinal product. Safety population includes ESA therapy naïve patients and ESA maintenance patients. Shown are all AEs including non-treatment related AEs. | 25 | 416 | 103 | 416 | 121 | 416 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Acute left ventricular failure | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Angina pectoris | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Angina unstable | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Atrial tachycardia | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Cardiac arrest | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Cardiac failure | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Cardiac failure acute | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Cardiomyopathy | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Cardiovascular insufficiency | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Carditis | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Congestive cardiomyopathy | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Myocardial infarction | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Myocarditis | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Adrenal mass | Endocrine disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Hyperparathyroidism | Endocrine disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Hyperparathyroidism secondary | Endocrine disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Gastritis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Haemorrhagic erosive gastritis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Calcinosis | General disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Death | General disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Multi-organ failure | General disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Systemic inflammatory response syndrome | General disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Hypersensitivity | Immune system disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Acute hepatitis b | Infections and infestations | MedDRA (17.0) | Systematic Assessment | † A |
|
| Appendicitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment | † A |
|
| Bronchopneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment | † A |
|
| Carbuncle | Infections and infestations | MedDRA (17.0) | Systematic Assessment | † A |
|
| Cellulitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment | † A |
|
| Device related infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment | † A |
|
| Endocarditis | Infections and infestations | MedDRA (17.0) | Systematic Assessment | † A |
|
| Erysipelas | Infections and infestations | MedDRA (17.0) | Systematic Assessment | † A |
|
| Intervertebral discitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment | † A |
|
| Laryngitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment | † A |
|
| Lobar pneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment | † A |
|
| Orchitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment | † A |
|
| Osteomyelitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment | † A |
|
| Peritonitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment | † A |
|
| Pneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment | † A |
|
| Pyelonephritis chronic | Infections and infestations | MedDRA (17.0) | Systematic Assessment | † A |
|
| Sepsis | Infections and infestations | MedDRA (17.0) | Systematic Assessment | † A |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA (17.0) | Systematic Assessment | † A |
|
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | † A |
|
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | † A |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | † A |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | † A |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | † A |
|
| Shunt occlusion | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | † A |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | † A |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | † A |
|
| Acidosis | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Cerebral haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment | † A |
|
| Glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment | † A |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Haemorrhagic cerebral infarction | Nervous system disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Ischaemic stroke | Nervous system disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Uraemic encephalopathy | Nervous system disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Azotaemia | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Diabetic nephropathy | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Renal cyst | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Renal failure | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Urinary retention | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Arteriosclerosis | Vascular disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Extremity necrosis | Vascular disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Haematoma | Vascular disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Hypertension | Vascular disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Hypertensive crisis | Vascular disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Hypertensive emergency | Vascular disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Oedema peripheral | General disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment | † A |
|
| Pneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment | † A |
|
| Urinary tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment | † A |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
| Hypertension | Vascular disorders | MedDRA (17.0) | Systematic Assessment | † A |
|
The Sponsor shall have the right to the first publication or presentation of the results of the study which is intended to be a joint, multi-center publication of the study results. Following the first publication, institutions and/or Principal Investigators may publish or present data or results from the study per the terms of the clinical trial agreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Biopharmaceutical Clinical Development, Strategic Planning | Sandoz | 0049 80244760 | biopharma.clinicaltrials@sandoz.com |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068817 | Epoetin Alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Turkey |
|
| Ukraine |
|
| Poland |
|
| Italy |
|
| Germany |
|
| OG002 |
| HX575 |
HX575 administered s.c. at least once per week. During the treatment period the dose was individually titrated to maintain hemoglobin levels between 10.0 and 12.0 g/dL. |
|
|