Trial Outcomes & Findings for Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD (NCT NCT00372489)
NCT ID: NCT00372489
Last Updated: 2012-06-29
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
Up to 54 months
Results posted on
2012-06-29
Participant Flow
Participant milestones
| Measure |
Peginesatide
Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
|
|---|---|
|
Overall Study
STARTED
|
81
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
79
|
Reasons for withdrawal
| Measure |
Peginesatide
Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
|
|---|---|
|
Overall Study
Adverse Event
|
18
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Patient Relocation
|
2
|
|
Overall Study
Renal transplant
|
6
|
|
Overall Study
Sponsor Decision to Terminate Study
|
41
|
Baseline Characteristics
Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD
Baseline characteristics by cohort
| Measure |
Peginesatide
n=81 Participants
Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=5 Participants
|
|
Age Continuous
|
59.8 years
STANDARD_DEVIATION 15.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 54 monthsPopulation: Full Analysis - Number of participants with hemoglobin assessed after dosing guideline change
Outcome measures
| Measure |
Peginesatide
n=60 Participants
Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
|
|---|---|
|
Proportion of Participants With Mean Hemoglobin in the Target Range of 10.0-12.0 Grams Per Deciliter (g/dL) After Dosing Guideline Change
|
0.867 percentage of participants
|
Adverse Events
Peginesatide
Serious events: 58 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peginesatide
n=81 participants at risk
Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.4%
6/81
|
|
Cardiac disorders
Cardiac failure congestive
|
19.8%
16/81
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
4.9%
4/81
|
|
General disorders
Chest pain
|
2.5%
2/81
|
|
Hepatobiliary disorders
Cholecystitis
|
1.2%
1/81
|
|
Immune system disorders
Sarcoidosis
|
1.2%
1/81
|
|
Infections and infestations
Pneumonia
|
11.1%
9/81
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
3.7%
3/81
|
|
Metabolism and nutrition disorders
Fluid overload
|
9.9%
8/81
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/81
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
1.2%
1/81
|
|
Nervous system disorders
Syncope
|
3.7%
3/81
|
|
Psychiatric disorders
Mental status changes
|
2.5%
2/81
|
|
Renal and urinary disorders
Renal failure chronic
|
3.7%
3/81
|
|
Reproductive system and breast disorders
Balanitis
|
1.2%
1/81
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
3.7%
3/81
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
1.2%
1/81
|
|
Vascular disorders
Hypertensive crisis
|
4.9%
4/81
|
|
Cardiac disorders
Acute myocardial infarction
|
11.1%
9/81
|
|
Gastrointestinal disorders
Gastritis
|
2.5%
2/81
|
|
General disorders
Non-cardiac chest pain
|
2.5%
2/81
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.2%
1/81
|
|
Infections and infestations
Sepsis
|
6.2%
5/81
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
2.5%
2/81
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.9%
4/81
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
1.2%
1/81
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.2%
1/81
|
|
Psychiatric disorders
Delirium
|
1.2%
1/81
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.2%
1/81
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.2%
1/81
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.5%
2/81
|
|
Vascular disorders
Hypertension
|
3.7%
3/81
|
|
Cardiac disorders
Coronary artery disease
|
6.2%
5/81
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.5%
2/81
|
|
General disorders
Catheter related complication
|
1.2%
1/81
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
1.2%
1/81
|
|
Infections and infestations
Gangrene
|
4.9%
4/81
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
2.5%
2/81
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.7%
3/81
|
|
Nervous system disorders
Dementia
|
1.2%
1/81
|
|
Renal and urinary disorders
Renal failure
|
1.2%
1/81
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
2/81
|
|
Vascular disorders
Peripheral vascular disorder
|
3.7%
3/81
|
|
Cardiac disorders
Atrial fibrillation
|
4.9%
4/81
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/81
|
|
General disorders
Catheter site haemorrhage
|
1.2%
1/81
|
|
Infections and infestations
Arteriovenous graft site infection
|
3.7%
3/81
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
1.2%
1/81
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
1.2%
1/81
|
|
Nervous system disorders
Dizziness
|
1.2%
1/81
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.5%
2/81
|
|
Vascular disorders
Deep vein thrombosis
|
2.5%
2/81
|
|
Cardiac disorders
Myocardial infarction
|
4.9%
4/81
|
|
Gastrointestinal disorders
Ascites
|
1.2%
1/81
|
|
General disorders
Multi-organ failure
|
1.2%
1/81
|
|
Infections and infestations
Bacteraemia
|
3.7%
3/81
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
1.2%
1/81
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
1.2%
1/81
|
|
Nervous system disorders
Metabolic encephalopathy
|
1.2%
1/81
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.2%
1/81
|
|
Vascular disorders
Hypotension
|
2.5%
2/81
|
|
Cardiac disorders
Cardio-respiratory arrest
|
3.7%
3/81
|
|
Gastrointestinal disorders
Colitis
|
1.2%
1/81
|
|
Infections and infestations
Gastroenteritis
|
3.7%
3/81
|
|
Injury, poisoning and procedural complications
Arteriovenous graft aneurysm
|
1.2%
1/81
|
|
Nervous system disorders
Migraine
|
1.2%
1/81
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
1/81
|
|
Vascular disorders
Aortic dissection
|
1.2%
1/81
|
|
Cardiac disorders
Angina pectoris
|
2.5%
2/81
|
|
Gastrointestinal disorders
Constipation
|
1.2%
1/81
|
|
Infections and infestations
Urinary tract infection
|
3.7%
3/81
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
1/81
|
|
Nervous system disorders
Polyneuropathy
|
1.2%
1/81
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.2%
1/81
|
|
Vascular disorders
Aortic stenosis
|
1.2%
1/81
|
|
Cardiac disorders
Bradycardia
|
2.5%
2/81
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.2%
1/81
|
|
Infections and infestations
Cellulitis
|
2.5%
2/81
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.2%
1/81
|
|
Nervous system disorders
Presyncope
|
1.2%
1/81
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
1/81
|
|
Vascular disorders
Arteriosclerosis
|
1.2%
1/81
|
|
Cardiac disorders
Ventricular tachycardia
|
2.5%
2/81
|
|
Gastrointestinal disorders
Gastritis erosive
|
1.2%
1/81
|
|
Infections and infestations
Clostridium difficile colitis
|
2.5%
2/81
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.2%
1/81
|
|
Nervous system disorders
Transient ischaemic attack
|
1.2%
1/81
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
1.2%
1/81
|
|
Vascular disorders
Jugular vein thrombosis
|
1.2%
1/81
|
|
Cardiac disorders
Acute coronary syndrome
|
1.2%
1/81
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.2%
1/81
|
|
Infections and infestations
Bronchitis
|
1.2%
1/81
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
1.2%
1/81
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
1/81
|
|
Vascular disorders
Lymphocele
|
1.2%
1/81
|
|
Cardiac disorders
Angina unstable
|
1.2%
1/81
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
1.2%
1/81
|
|
Infections and infestations
Catheter sepsis
|
1.2%
1/81
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.2%
1/81
|
|
Cardiac disorders
Atrial thrombosis
|
1.2%
1/81
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.2%
1/81
|
|
Infections and infestations
Escherichia sepsis
|
1.2%
1/81
|
|
Injury, poisoning and procedural complications
Sternal injury
|
1.2%
1/81
|
|
Cardiac disorders
Cardiac arrest
|
1.2%
1/81
|
|
Gastrointestinal disorders
Hiatus hernia
|
1.2%
1/81
|
|
Infections and infestations
Extradural abscess
|
1.2%
1/81
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
1.2%
1/81
|
|
Cardiac disorders
Cardiogenic shock
|
1.2%
1/81
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.2%
1/81
|
|
Infections and infestations
Graft infection
|
1.2%
1/81
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
1.2%
1/81
|
|
Cardiac disorders
Cardiomyopathy
|
1.2%
1/81
|
|
Infections and infestations
Lobar pneumonia
|
1.2%
1/81
|
|
Cardiac disorders
Pericardial effusion
|
1.2%
1/81
|
|
Infections and infestations
Postoperative wound infection
|
1.2%
1/81
|
|
Cardiac disorders
Sinus tachycardia
|
1.2%
1/81
|
|
Infections and infestations
Pyelonephritis
|
1.2%
1/81
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.2%
1/81
|
|
Infections and infestations
Septic shock
|
1.2%
1/81
|
|
Cardiac disorders
Ventricular arrhythmia
|
1.2%
1/81
|
|
Infections and infestations
Staphylococcal infection
|
1.2%
1/81
|
|
Cardiac disorders
Ventricular fibrillation
|
1.2%
1/81
|
|
Infections and infestations
Staphylococcal sepsis
|
1.2%
1/81
|
|
Infections and infestations
Streptococcal sepsis
|
1.2%
1/81
|
|
Infections and infestations
Tubo-ovarian abscess
|
1.2%
1/81
|
|
Infections and infestations
Urosepsis
|
1.2%
1/81
|
|
Infections and infestations
Vulval abscess
|
1.2%
1/81
|
Other adverse events
| Measure |
Peginesatide
n=81 participants at risk
Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.3%
10/81
|
|
Cardiac disorders
Tachycardia
|
8.6%
7/81
|
|
Endocrine disorders
Hyperparathyroidism
|
7.4%
6/81
|
|
Eye disorders
Conjunctivitis
|
6.2%
5/81
|
|
Gastrointestinal disorders
Diarrhoea
|
24.7%
20/81
|
|
Gastrointestinal disorders
Vomiting
|
19.8%
16/81
|
|
Gastrointestinal disorders
Nausea
|
16.0%
13/81
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
9/81
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
5/81
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
5/81
|
|
General disorders
Pyrexia
|
19.8%
16/81
|
|
General disorders
Oedema peripheral
|
14.8%
12/81
|
|
General disorders
Chest pain
|
13.6%
11/81
|
|
General disorders
Asthenia
|
9.9%
8/81
|
|
General disorders
Chest discomfort
|
9.9%
8/81
|
|
General disorders
Fatigue
|
8.6%
7/81
|
|
General disorders
Chills
|
7.4%
6/81
|
|
General disorders
Pain
|
6.2%
5/81
|
|
Infections and infestations
Upper respiratory tract infection
|
28.4%
23/81
|
|
Infections and infestations
Nasopharyngitis
|
17.3%
14/81
|
|
Infections and infestations
Sinusitis
|
9.9%
8/81
|
|
Infections and infestations
Cellulitis
|
6.2%
5/81
|
|
Infections and infestations
Urinary tract infection
|
6.2%
5/81
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
28.4%
23/81
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
18.5%
15/81
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
14.8%
12/81
|
|
Injury, poisoning and procedural complications
Fall
|
7.4%
6/81
|
|
Injury, poisoning and procedural complications
Procedural headache
|
7.4%
6/81
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
6.2%
5/81
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
6.2%
5/81
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
6.2%
5/81
|
|
Injury, poisoning and procedural complications
Wound
|
6.2%
5/81
|
|
Investigations
Breath sounds abnormal
|
8.6%
7/81
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
17.3%
14/81
|
|
Metabolism and nutrition disorders
Iron deficiency
|
16.0%
13/81
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
13.6%
11/81
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
11.1%
9/81
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
8.6%
7/81
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
7.4%
6/81
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
23.5%
19/81
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
23.5%
19/81
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.6%
11/81
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.3%
10/81
|
|
Nervous system disorders
Dizziness
|
12.3%
10/81
|
|
Nervous system disorders
Headache
|
12.3%
10/81
|
|
Nervous system disorders
Hypoaesthesia
|
7.4%
6/81
|
|
Psychiatric disorders
Insomnia
|
13.6%
11/81
|
|
Psychiatric disorders
Anxiety
|
7.4%
6/81
|
|
Psychiatric disorders
Depression
|
7.4%
6/81
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
24.7%
20/81
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.8%
12/81
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.9%
8/81
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.2%
5/81
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
9/81
|
|
Vascular disorders
Hypertension
|
12.3%
10/81
|
|
Vascular disorders
Hypotension
|
7.4%
6/81
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publications may not contain Sponsor confidential information, and may be subject to Sponsor review 30 days prior to submission for publication.
- Publication restrictions are in place
Restriction type: OTHER