Trial Outcomes & Findings for Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD (EU) (NCT NCT00453973)
NCT ID: NCT00453973
Last Updated: 2012-06-29
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
114 participants
Primary outcome timeframe
Up to 54 months
Results posted on
2012-06-29
Participant Flow
Participant milestones
| Measure |
Maintenance Switch in Dialysis Participants
Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as "Maintenance Switch in Dialysis Participants" regardless of dialysis status at the start of or during this study.
|
Treatment Initiation in Non-Dialysis Participants
Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as "Initiation of Treatment in Non-Dialysis Participants" regardless of dialysis status at the start of or during this study.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
63
|
|
Overall Study
COMPLETED
|
0
|
15
|
|
Overall Study
NOT COMPLETED
|
51
|
48
|
Reasons for withdrawal
| Measure |
Maintenance Switch in Dialysis Participants
Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as "Maintenance Switch in Dialysis Participants" regardless of dialysis status at the start of or during this study.
|
Treatment Initiation in Non-Dialysis Participants
Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as "Initiation of Treatment in Non-Dialysis Participants" regardless of dialysis status at the start of or during this study.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
9
|
|
Overall Study
Withdrawal by Subject
|
7
|
6
|
|
Overall Study
PI Decision
|
0
|
2
|
|
Overall Study
Relocation
|
1
|
0
|
|
Overall Study
Renal transplant
|
1
|
1
|
|
Overall Study
Site closed by sponsor
|
3
|
0
|
|
Overall Study
Sponsor Decision to Terminate Study
|
35
|
30
|
Baseline Characteristics
Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD (EU)
Baseline characteristics by cohort
| Measure |
Maintenance Switch in Dialysis Participants
n=51 Participants
Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as "Maintenance Switch in Dialysis Participants" regardless of dialysis status at the start of or during this study.
|
Treatment Initiation in Non-Dialysis Participants
n=63 Participants
Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as "Initiation of Treatment in Non-Dialysis Participants" regardless of dialysis status at the start of or during this study.
|
Pooled AF37702 Inj.
n=114 Participants
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age Continuous
|
53.2 years
STANDARD_DEVIATION 11.92 • n=5 Participants
|
66.4 years
STANDARD_DEVIATION 13.48 • n=7 Participants
|
60.5 years
STANDARD_DEVIATION 14.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
61 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 |
Maintenance Switch in Dialysis Participants
n=28 Participants
Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as "Maintenance Switch in Dialysis Participants" regardless of dialysis status at the start of or during this study.
|
Treatment Initiation in Non-Dialysis Participants
n=40 Participants
Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as "Initiation of Treatment in Non-Dialysis Participants" regardless of dialysis status at the start of or during this study.
|
|---|---|---|
|
Proportion of Participants With Mean Hemoglobin in the Target Range of 10.0-12.0 Grams Per Deciliter (g/dL) After Final Dosing Guideline Change
|
0.786 percentage of participants
|
0.875 percentage of participants
|
Adverse Events
Maintenance Switch in Dialysis Participants
Serious events: 10 serious events
Other events: 46 other events
Deaths: 0 deaths
Treatment Initiation in Non-Dialysis Participants
Serious events: 31 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Maintenance Switch in Dialysis Participants
n=51 participants at risk
Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as "Maintenance Switch in Dialysis Participants" regardless of dialysis status at the start of or during this study.
|
Treatment Initiation in Non-Dialysis Participants
n=63 participants at risk
Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as "Initiation of Treatment in Non-Dialysis Participants" regardless of dialysis status at the start of or during this study.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
3.9%
2/51
|
1.6%
1/63
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/51
|
3.2%
2/63
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/51
|
3.2%
2/63
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/51
|
3.2%
2/63
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/51
|
1.6%
1/63
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/51
|
1.6%
1/63
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/51
|
1.6%
1/63
|
|
Cardiac disorders
Cardiac tamponade
|
2.0%
1/51
|
0.00%
0/63
|
|
Cardiac disorders
Cardiogenic shock
|
2.0%
1/51
|
0.00%
0/63
|
|
Cardiac disorders
Cardiopulmonary failure
|
2.0%
1/51
|
0.00%
0/63
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/51
|
1.6%
1/63
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/51
|
1.6%
1/63
|
|
Cardiac disorders
Pericardial haemorrhage
|
2.0%
1/51
|
0.00%
0/63
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/51
|
1.6%
1/63
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/51
|
1.6%
1/63
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/51
|
1.6%
1/63
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/51
|
1.6%
1/63
|
|
General disorders
Catheter related complication
|
0.00%
0/51
|
3.2%
2/63
|
|
General disorders
Pyrexia
|
0.00%
0/51
|
1.6%
1/63
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/51
|
1.6%
1/63
|
|
Infections and infestations
Pneumonia
|
2.0%
1/51
|
1.6%
1/63
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/51
|
3.2%
2/63
|
|
Infections and infestations
Arteriovenous fistula site infection
|
2.0%
1/51
|
0.00%
0/63
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/51
|
1.6%
1/63
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/51
|
1.6%
1/63
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/51
|
1.6%
1/63
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/51
|
1.6%
1/63
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/51
|
1.6%
1/63
|
|
Infections and infestations
Localised infection
|
2.0%
1/51
|
0.00%
0/63
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/51
|
1.6%
1/63
|
|
Infections and infestations
Lung infection
|
2.0%
1/51
|
0.00%
0/63
|
|
Infections and infestations
Pyelonephritis chronic
|
2.0%
1/51
|
0.00%
0/63
|
|
Infections and infestations
Sepsis
|
0.00%
0/51
|
1.6%
1/63
|
|
Infections and infestations
Staphylococcal sepsis
|
2.0%
1/51
|
0.00%
0/63
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/51
|
1.6%
1/63
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/51
|
1.6%
1/63
|
|
Injury, poisoning and procedural complications
Joint sprain
|
2.0%
1/51
|
0.00%
0/63
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/51
|
1.6%
1/63
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.0%
1/51
|
4.8%
3/63
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/51
|
1.6%
1/63
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.00%
0/51
|
1.6%
1/63
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/51
|
1.6%
1/63
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/51
|
1.6%
1/63
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/51
|
1.6%
1/63
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/51
|
1.6%
1/63
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/51
|
1.6%
1/63
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
2.0%
1/51
|
0.00%
0/63
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/51
|
1.6%
1/63
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/51
|
1.6%
1/63
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.00%
0/51
|
1.6%
1/63
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/51
|
1.6%
1/63
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/51
|
3.2%
2/63
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/51
|
1.6%
1/63
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/51
|
1.6%
1/63
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/51
|
1.6%
1/63
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/51
|
1.6%
1/63
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.0%
1/51
|
1.6%
1/63
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/51
|
1.6%
1/63
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/51
|
3.2%
2/63
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/51
|
1.6%
1/63
|
|
Vascular disorders
Hypertension
|
0.00%
0/51
|
3.2%
2/63
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/51
|
1.6%
1/63
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/51
|
1.6%
1/63
|
|
Vascular disorders
Haematoma
|
2.0%
1/51
|
0.00%
0/63
|
|
Vascular disorders
Hypertensive crisis
|
2.0%
1/51
|
0.00%
0/63
|
Other adverse events
| Measure |
Maintenance Switch in Dialysis Participants
n=51 participants at risk
Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as "Maintenance Switch in Dialysis Participants" regardless of dialysis status at the start of or during this study.
|
Treatment Initiation in Non-Dialysis Participants
n=63 participants at risk
Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as "Initiation of Treatment in Non-Dialysis Participants" regardless of dialysis status at the start of or during this study.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
5.9%
3/51
|
3.2%
2/63
|
|
Ear and labyrinth disorders
Vertigo
|
7.8%
4/51
|
1.6%
1/63
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
7.8%
4/51
|
0.00%
0/63
|
|
Gastrointestinal disorders
Nausea
|
19.6%
10/51
|
15.9%
10/63
|
|
Gastrointestinal disorders
Abdominal pain
|
17.6%
9/51
|
4.8%
3/63
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.8%
6/51
|
1.6%
1/63
|
|
Gastrointestinal disorders
Diarrhoea
|
9.8%
5/51
|
6.3%
4/63
|
|
Gastrointestinal disorders
Vomiting
|
9.8%
5/51
|
7.9%
5/63
|
|
Gastrointestinal disorders
Toothache
|
7.8%
4/51
|
0.00%
0/63
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/51
|
6.3%
4/63
|
|
General disorders
Chest pain
|
9.8%
5/51
|
1.6%
1/63
|
|
General disorders
Catheter site haemorrhage
|
7.8%
4/51
|
0.00%
0/63
|
|
General disorders
Influenza like illness
|
3.9%
2/51
|
6.3%
4/63
|
|
General disorders
Fatigue
|
2.0%
1/51
|
9.5%
6/63
|
|
General disorders
Oedema peripheral
|
2.0%
1/51
|
19.0%
12/63
|
|
Infections and infestations
Bronchitis
|
17.6%
9/51
|
11.1%
7/63
|
|
Infections and infestations
Tracheobronchitis
|
11.8%
6/51
|
0.00%
0/63
|
|
Infections and infestations
Hepatitis C
|
9.8%
5/51
|
0.00%
0/63
|
|
Infections and infestations
Tooth abscess
|
9.8%
5/51
|
0.00%
0/63
|
|
Infections and infestations
Respiratory tract infection viral
|
7.8%
4/51
|
0.00%
0/63
|
|
Infections and infestations
Urinary tract infection
|
7.8%
4/51
|
11.1%
7/63
|
|
Infections and infestations
Catheter related infection
|
5.9%
3/51
|
0.00%
0/63
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/51
|
20.6%
13/63
|
|
Infections and infestations
Influenza
|
0.00%
0/51
|
14.3%
9/63
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/51
|
7.9%
5/63
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
17.6%
9/51
|
0.00%
0/63
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
13.7%
7/51
|
1.6%
1/63
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
11.8%
6/51
|
0.00%
0/63
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
11.8%
6/51
|
3.2%
2/63
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
7.8%
4/51
|
1.6%
1/63
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haematoma
|
5.9%
3/51
|
0.00%
0/63
|
|
Injury, poisoning and procedural complications
Procedural headache
|
5.9%
3/51
|
0.00%
0/63
|
|
Injury, poisoning and procedural complications
Contusion
|
3.9%
2/51
|
6.3%
4/63
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/51
|
6.3%
4/63
|
|
Investigations
Blood pressure increased
|
11.8%
6/51
|
4.8%
3/63
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.9%
3/51
|
0.00%
0/63
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.9%
2/51
|
6.3%
4/63
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/51
|
7.9%
5/63
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/51
|
6.3%
4/63
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
43.1%
22/51
|
4.8%
3/63
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
6/51
|
9.5%
6/63
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.8%
4/51
|
11.1%
7/63
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.8%
4/51
|
3.2%
2/63
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
3/51
|
7.9%
5/63
|
|
Nervous system disorders
Headache
|
54.9%
28/51
|
7.9%
5/63
|
|
Nervous system disorders
Dizziness
|
5.9%
3/51
|
7.9%
5/63
|
|
Psychiatric disorders
Insomnia
|
7.8%
4/51
|
4.8%
3/63
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/51
|
7.9%
5/63
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.8%
6/51
|
6.3%
4/63
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.8%
4/51
|
1.6%
1/63
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
7.8%
4/51
|
0.00%
0/63
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/51
|
9.5%
6/63
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/51
|
6.3%
4/63
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
21.6%
11/51
|
0.00%
0/63
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.8%
5/51
|
9.5%
6/63
|
|
Vascular disorders
Hypertensive crisis
|
37.3%
19/51
|
0.00%
0/63
|
|
Vascular disorders
Hypotension
|
37.3%
19/51
|
6.3%
4/63
|
|
Vascular disorders
Hypertension
|
7.8%
4/51
|
20.6%
13/63
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publications may not contain Sponsor confidential information, and will be subject to Sponsor review prior to submission for publication.
- Publication restrictions are in place
Restriction type: OTHER