Trial Outcomes & Findings for HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD) (NCT NCT01576341)
NCT ID: NCT01576341
Last Updated: 2017-06-19
Results Overview
The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
417 participants
Primary outcome timeframe
52 weeks
Results posted on
2017-06-19
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
417
|
|
Overall Study
COMPLETED
|
324
|
|
Overall Study
NOT COMPLETED
|
93
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
24
|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
Death
|
21
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Kidney transplantation
|
10
|
|
Overall Study
Protocol Violation
|
12
|
|
Overall Study
Other
|
12
|
Baseline Characteristics
HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD)
Baseline characteristics by cohort
| Measure |
HX575, Safety Population
n=416 Participants
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.
|
|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 15.78 • n=5 Participants
|
|
Sex: Female, Male
Female
|
218 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
198 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
416 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
107 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
40 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
33 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
179 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
47 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
5 participants
n=5 Participants
|
|
Height
|
166.9 cm
STANDARD_DEVIATION 9.44 • n=5 Participants
|
|
Weight
|
70.6 kg
STANDARD_DEVIATION 15.92 • n=5 Participants
|
|
Body Mass Index (BMI)
|
25.26 kg/m^2
STANDARD_DEVIATION 5.073 • n=5 Participants
|
|
ESA pre-treatment
ESA naive
|
250 participants
n=5 Participants
|
|
ESA pre-treatment
ESA maintenance
|
166 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Safety population: The safety population consists of all patients that received at least one dose of study drug
The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay
Outcome measures
| Measure |
HX575
n=416 Participants
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
|
HX575 - ESA Maintenance
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. At study start patients were either ESA (Erythropoiesis Stimulating Agent) naive or on ESA maintenance treatment. This group only contains patients that were on ESA maintenance treatment at study start, e.g. did receive at least one dose of commercial ESA treatment within 2 months prior to first screening visit.
|
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.
|
|---|---|---|---|
|
Anti-Erythropoietin (EPO) Antibodies
|
1.7 percentage of participants
Interval 0.7 to 3.4
|
—
|
—
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: 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).
Actual values of hemoglobin levels at end of study visit and change from Baseline Period (Week -4 to Week -1)
Outcome measures
| Measure |
HX575
n=199 Participants
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
|
HX575 - ESA Maintenance
n=144 Participants
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. At study start patients were either ESA (Erythropoiesis Stimulating Agent) naive or on ESA maintenance treatment. This group only contains patients that were on ESA maintenance treatment at study start, e.g. did receive at least one dose of commercial ESA treatment within 2 months prior to first screening visit.
|
HX575
n=343 Participants
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.
|
|---|---|---|---|
|
Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study)
Actual Value
|
10.81 g/dL
Standard Deviation 1.336
|
10.86 g/dL
Standard Deviation 1.060
|
10.83 g/dL
Standard Deviation 1.226
|
|
Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study)
Change from Baseline Period
|
1.61 g/dL
Standard Deviation 1.601
|
0.22 g/dL
Standard Deviation 1.223
|
1.02 g/dL
Standard Deviation 1.606
|
Adverse Events
HX575, Safety Population
Serious events: 103 serious events
Other events: 121 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
HX575, Safety Population
n=416 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Cardiac disorders
Acute coronary syndrome
|
0.48%
2/416 • Number of events 2 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Cardiac disorders
Acute left ventricular failure
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.48%
2/416 • Number of events 2 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Cardiac disorders
Angina pectoris
|
0.72%
3/416 • Number of events 3 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Cardiac disorders
Angina unstable
|
0.48%
2/416 • Number of events 3 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Cardiac disorders
Atrial fibrillation
|
0.48%
2/416 • Number of events 2 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Cardiac disorders
Atrial tachycardia
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Cardiac disorders
Cardiac arrest
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Cardiac disorders
Cardiac failure
|
0.48%
2/416 • Number of events 2 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Cardiac disorders
Cardiac failure acute
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Cardiac disorders
Cardiac failure chronic
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Cardiac disorders
Cardiomyopathy
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.48%
2/416 • Number of events 2 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Cardiac disorders
Carditis
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Cardiac disorders
Coronary artery stenosis
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
5/416 • Number of events 5 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Cardiac disorders
Myocardial ischaemia
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Cardiac disorders
Myocarditis
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Endocrine disorders
Adrenal mass
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Endocrine disorders
Hyperparathyroidism
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
0.48%
2/416 • Number of events 2 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Gastrointestinal disorders
Gastritis
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.24%
1/416 • Number of events 2 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Gastrointestinal disorders
Oesophagitis
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
General disorders
Calcinosis
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
General disorders
Death
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
General disorders
Multi-organ failure
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
General disorders
Systemic inflammatory response syndrome
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Hepatobiliary disorders
Bile duct stone
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Immune system disorders
Hypersensitivity
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Infections and infestations
Acute hepatitis b
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Infections and infestations
Appendicitis
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Infections and infestations
Bronchopneumonia
|
0.48%
2/416 • Number of events 2 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Infections and infestations
Carbuncle
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Infections and infestations
Cellulitis
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Infections and infestations
Device related infection
|
0.48%
2/416 • Number of events 3 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Infections and infestations
Endocarditis
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Infections and infestations
Erysipelas
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Infections and infestations
Intervertebral discitis
|
0.48%
2/416 • Number of events 2 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Infections and infestations
Laryngitis
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Infections and infestations
Lobar pneumonia
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Infections and infestations
Orchitis
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Infections and infestations
Osteomyelitis
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Infections and infestations
Peritonitis
|
1.2%
5/416 • Number of events 6 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Infections and infestations
Pneumonia
|
1.2%
5/416 • Number of events 5 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Infections and infestations
Pyelonephritis chronic
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Infections and infestations
Sepsis
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Infections and infestations
Staphylococcal sepsis
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.48%
2/416 • Number of events 2 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Metabolism and nutrition disorders
Acidosis
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebral haemangioma
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.72%
3/416 • Number of events 3 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Nervous system disorders
Ischaemic stroke
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Nervous system disorders
Transient ischaemic attack
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Renal and urinary disorders
Azotaemia
|
0.48%
2/416 • Number of events 2 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.24%
1/416 • Number of events 2 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Renal and urinary disorders
Renal cyst
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Renal and urinary disorders
Renal failure
|
0.48%
2/416 • Number of events 2 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Renal and urinary disorders
Renal failure chronic
|
4.8%
20/416 • Number of events 24 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Renal and urinary disorders
Urinary retention
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.24%
1/416 • Number of events 2 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.48%
2/416 • Number of events 2 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.48%
2/416 • Number of events 2 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.48%
2/416 • Number of events 2 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Vascular disorders
Arteriosclerosis
|
0.24%
1/416 • Number of events 2 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Vascular disorders
Extremity necrosis
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Vascular disorders
Haematoma
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Vascular disorders
Hypertension
|
1.2%
5/416 • Number of events 5 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Vascular disorders
Hypertensive crisis
|
0.48%
2/416 • Number of events 2 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Vascular disorders
Hypertensive emergency
|
0.24%
1/416 • Number of events 1 • 4 weeks (screening period) + 52 weeks (treatment period)
|
Other adverse events
| Measure |
HX575, Safety Population
n=416 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
9/416 • Number of events 11 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
General disorders
Oedema peripheral
|
2.2%
9/416 • Number of events 13 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
13/416 • Number of events 15 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Infections and infestations
Pneumonia
|
2.4%
10/416 • Number of events 13 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Infections and infestations
Urinary tract infection
|
2.2%
9/416 • Number of events 11 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.6%
19/416 • Number of events 25 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Renal and urinary disorders
Renal failure chronic
|
9.4%
39/416 • Number of events 42 • 4 weeks (screening period) + 52 weeks (treatment period)
|
|
Vascular disorders
Hypertension
|
10.1%
42/416 • Number of events 75 • 4 weeks (screening period) + 52 weeks (treatment period)
|
Additional Information
Biopharmaceutical Clinical Development, Strategic Planning
Sandoz
Phone: 0049 80244760
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER