Conversion Study From Epoetin Alfa to Monthly Peginesatid... | NCT01478971

ID	Type	Description	Link
U1111-1150-2575	Registry Identifier	WHO

Name	Class
Affymax	INDUSTRY

Label	Type	Description	Intervention Names
peginesatide injection	Experimental	In the first 6 months participants received standard of care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1-week erythropoiesis-stimulating agent (ESA)-Free Period, followed by peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).	Drug: Epoetin Drug: Peginesatide

Name	Type	Description	Arm Group Labels	Other Names
Epoetin	Drug	Commercially available epoetin alfa administered weekly, twice weekly, or thrice weekly at an initial starting dose, frequency of administration, and mode of administration (intravenous [IV] or subcutaneous [SC]) individually determined for each participant using the site's usual standard of care. Subsequent dose adjustments or dose holds may have been made in order to maintain a hemoglobin concentration of <11 g/dL.

Measure	Description	Time Frame
Percentage of Participants Undergoing Conversion to Peginesatide Injection		6 months

Measure	Description	Time Frame
Peginesatide Dosing	The starting dose, mean dose throughout the study, and mean dose during the last week of treatment of peginesatide.	Month 6 - 12
Peginesatide Dose Deviations	Data collected by sponsor of study (Affymax), and sponsor did not provide aggregate summary data.

Name	Affiliation	Role
Medical Director, Clinical Science	Takeda	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Facility		Sacramento	California	95825	United States
Research Facility

ID	Title	Description
FG000	Peginesatide Injection	In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).

ID	Title	Description
BG000	Peginesatide Injection	In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).

Units	Counts
Participants	BG000178

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 Undergoing Conversion to Peginesatide Injection

All participants who received at least one dose of study treatment.

Posted

Number

percentage of participants

6 months

ID	Title	Description
OG000	Peginesatide Injection	In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).

Units	Counts
Participants	OG000178

Title

Denominators

Categories

Title	Measurements
	OG00088

Secondary

Peginesatide Dosing

The starting dose, mean dose throughout the study, and mean dose during the last week of treatment of peginesatide.

Participants who received at least 1 dose of study treatment during the Peginesatide Treatment Period.

Posted

Mean

Standard Deviation

Month 6 - 12

ID	Title	Description
OG000	Peginesatide Injection	In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).

Units	Counts
Participants	OG000

Secondary

Peginesatide Dose Deviations

Data collected by sponsor of study (Affymax), and sponsor did not provide aggregate summary data.

Posted

Months 6 - 12

ID	Title	Description
OG000	Peginesatide Injection	In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).

Units	Counts
Participants	OG0000

Secondary

Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL

Percentage of participants with hemoglobin values within the hemoglobin range of 10-11 g/dL.

Full Analysis Population included all enrolled participants who received at least 1 dose of study treatment during the Peginesatide Treatment Period. n indicates the number of participants with available data at each time point.

Posted

Number

percentage of participants

Months 1, 2, 3, 4, 5 and 6 of each treatment period

ID	Title	Description
OG000	Epoetin Standard of Care	In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]).
OG001	Peginesatide Treatment Period	In the second six months of the study participants transitioned to peginesatide injection (the Peginesatide Treatment Period [PTP]).

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Received at Least One Intravenous Iron Dose

Participants received iron supplementation during the study to prevent iron deficiency and to maintain iron stores.

Safety population

Posted

Number

percentage of participants

12 months

ID	Title	Description
OG000	Epoetin Standard of Care	In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]).
OG001	Peginesatide Treatment Period	In the second six months of the study participants transitioned to peginesatide injection (the Peginesatide Treatment Period [PTP]).

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion

Safety population

Posted

Number

percentage of participants

12 months

ID	Title	Description
OG000	Epoetin Standard of Care	In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]).
OG001	Peginesatide Treatment Period	In the second six months of the study participants transitioned to peginesatide injection (the Peginesatide Treatment Period [PTP]).

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0022 affected157 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected178 at risk EG0010 affected160 at risk EG0026 affected157 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected178 at risk EG0010 affected160 at risk EG0024 affected157 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected178 at risk EG0010 affected160 at risk EG0022 affected157 at risk
Cardiac arrest	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Angina pectoris	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0022 affected157 at risk
Myocardial infarction	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Atrial flutter	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Retinal detachment	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected178 at risk EG0010 affected160 at risk EG0023 affected157 at risk
Ascites	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected178 at risk EG0010 affected160 at risk EG0022 affected157 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Chest pain	General disorders	MedDRA 14.1	Systematic Assessment	EG0005 affected178 at risk EG0010 affected160 at risk EG0022 affected157 at risk
Asthenia	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0022 affected157 at risk
Pyrexia	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Device malfunction	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Fatigue	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Oedema peripheral	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0022 affected157 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Pneumonia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0008 affected178 at risk EG0010 affected160 at risk EG0022 affected157 at risk
Sepsis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0006 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0006 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Gangrene	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0003 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Arteriovenous fistula site infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0022 affected157 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0022 affected157 at risk
Cellulitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected178 at risk EG0011 affected160 at risk EG0021 affected157 at risk
Device related sepsis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Infectious peritonitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Septic shock	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Wound infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Abdominal abscess	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Appendicitis perforated	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Bronchitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Cholangitis suppurative	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Empyema	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Enterococcal infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Klebsiella sepsis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Lung abscess	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Osteomyelitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Peritonitis bacterial	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0003 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Troponin increased	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected178 at risk EG0011 affected160 at risk EG0025 affected157 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected178 at risk EG0011 affected160 at risk EG0023 affected157 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Spinal disorder	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Encephalopathy	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Syncope	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Convulsion	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Grand mal convulsion	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Myoclonus	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Mental status changes	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected178 at risk EG0010 affected160 at risk EG0024 affected157 at risk
Delirium	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Depression	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Hallucination	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0023 affected157 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected178 at risk EG0010 affected160 at risk EG0022 affected157 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Dry gangrene	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Hypertension	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0024 affected157 at risk
Hypotension	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected178 at risk EG0010 affected160 at risk EG0023 affected157 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Hypertensive crisis	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Ischaemia	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Raynaud's phenomenon	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected178 at risk EG0010 affected160 at risk EG0020 affected157 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Arrhythmia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Nodal rhythm	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Colitis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Gastric antral vascular ectasia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Oesophageal achalasia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Death	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Face oedema	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Generalised oedema	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Pain	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Arthritis infective	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Bacteraemia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Escherichia sepsis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Gastroenteritis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0022 affected157 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0022 affected157 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0023 affected157 at risk
Diabetic foot	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Hypoglycaemic seizure	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Gallbladder cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Renal cell carcinoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Confusional state	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Haematuria	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0022 affected157 at risk
Brachiocephalic vein stenosis	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected178 at risk EG0010 affected160 at risk EG0021 affected157 at risk

ID	Term
D051436	Renal Insufficiency, Chronic
D000740	Anemia
D007676	Kidney Failure, 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
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D004921	Erythropoietin
C556270	peginesatide
C514771	hematide

ID	Term
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

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Epoetin Standard of Care	In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]).	64	178	74	178
EG001	ESA Free Week	A one-week erythropoiesis-stimulating agent (ESA)-free period following 6 months of standard of care.	2	160	7	160
EG002	Peginesatide Treatment Period	In the second six months of the study participants transitioned to once monthly peginesatide injection (the Peginesatide Treatment Period [PTP]).	54	157	70	157